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A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in Extreme FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports. Another approach is to buy a basket of stocks well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume. As with previous installments, this article is neither an endorsement of the companies profiled nor a complete list of extreme trades included in the FDA Calendar at BioMedReports.

With shares of Human Genome Sciences (NASDAQ:HGSI) more than tripling today on positive Phase 3 results for its experimental lupus drug since being featured as an Extreme FDA Calendar trade in early July, the list below includes an updated selection of companies with stock prices below $5/share. Keep in mind that the FDA does not issue PDUFA decision date deadlines for medical device applications, which consist of the 510(k) and pre-market notification application (PMA) routes. Click here for more info at the FDA website regarding the regulatory approval process for medical devices.

On 7/20/09, Trinity Biotech (NASDAQ:TRIB) ($4.88) announced the submission of a CLIA application for its TRI-stat point-of-care HbA1c product to the FDA.TRI-stat is designed to measure HbA1c, also known as glycated hemoglobin, a measure of a patient's average blood sugar control over the trailing two to three month period. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration found with the other three competing products.

On 5/29/09, Theratechnologies (TSE:TH) (PINK:THTCF) ($2.00) filed a New Drug Application (NDA) with the FDA for tesamorelin, an analogue of the growth hormone releasing factor, proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy. Several factors including the antiretroviral drug regimen and the virus itself are thought to contribute to HIV-associated lipodystrophy, which is characterized by body composition changes, dyslipidemia and glucose intolerance. The changes in body composition include excess abdominal fat accumulation. There is currently no approved treatment available for the excess abdominal fat related to HIV-associated lipodystrophy, a condition that can stigmatize patients and discourage HIV treatment adherence. The estimated PDUFA decision date for a standard, 10-month review by the FDA is expected to occur in late 1Q10.

On 7/20/09, A.P. Pharma (NASDAQ:APPA) ($0.88) announced that the FDA accepted for review the Company's New Drug Application (NDA) for APF530 for the potential treatment of chemotherapy-induced nausea and vomiting (CINV) with a PDUFA action date set for late 1Q10 for a possible FDA decision. APF530 is a long-acting formulation of granisetron that utilizes the Company's proprietary Biochronomer drug delivery system. The NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA's prior safety and efficacy findings for APF530's active ingredient, granisetron, which is already approved by the Agency.

On 7/14/09, Genta (OTC:GETA) ($0.34) announced the publication of a paper that independently confirms the link of a key biomarker to overall survival in patients with advanced melanoma. The biomarker, a tumor-derived enzyme known as lactate dehydrogenase (LDH), is measured by a widely available blood test. Genta's recently completed Phase 3 trial of Genasense in advanced melanoma, known as AGENDA, specified low-normal LDH as an enrollment criterion. Results for progression-free survival (PFS), a co-primary endpoint of AGENDA along with overall survival (OS), are anticipated during 4Q09 and, if positive, are expected to support global regulatory applications for Genasense in this indication.

On 5/19/09, Genta announced that the independent Data Monitoring Board (DMB) for AGENDA notified the Company that the study passed its final futility analysis for progression-free survival (PFS). Accordingly, the Board has recommended that the study should continue to completion. Coincident with this recommendation, Genta submitted an "intent-to-file" notice via the centralized procedure to the European Medicines Agency (EMEA), which is required prior to submission of a Marketing Authorization Application (MAA) for marketing approval in Europe.

On 7/13/09, Genta began trading under a new ticker (GETA.OB) after implementing a previously announced one-for-fifty reverse stock split of its common stock which reduced the number of outstanding shares from about 5.4 billion to around 108 million shares.

On 6/30/09, AspenBio Pharma (NASDAQ:APPY) ($2.20) announced a 510(k) submission to the FDA for its AppyScore Test, which represents the first blood-based test designed as an aid in the diagnosis of human appendicitis with the proposed indication of use: AppyScore is an ELISA test system that is used to quantitatively measure S100A8/A9 heterodimer complex in blood. It is an in vitro diagnostic device that is intended to be used as an adjunctive tool for the diagnosis of acute appendicitis in conjunction with additional diagnostic modalities (such as clinical exam, basic lab testing, imaging) in patients with abdominal pain that is suspicious for acute appendicitis.

This filing advances the Company's commercialization plan for AppyScore, which involves initially filing the 510(k) based on the ELISA test format. Upon receiving market clearance for this device, the company plans to use the ELISA device as a predicate for a rapid assay device that includes a reader instrument. AspenBio plans to begin initial hospital testing of the rapid assay device in late 2009. Assuming the company receives FDA clearance of the AppyScore ELISA test and development work is completed, clinical trials of the rapid assay are planned to begin in early 2010.

Javelin Pharma (AMEX:JAV) ($1.60): Ereska is a non-opiate pain drug being developed by JAV for the acute treatment of moderate to severe pain in military, trauma, post-operative, and emergency room settings with the potential for treating breakthrough pain from cancer as well. The drug is delivered by a disposable manual pump with a rapid onset and duration of pain relief of about two hours without opiate side effects such as respiratory depression. JAV expects to release the primary endpoint data from the Ereska (intranasal ketamine) Phase 3 pivotal trial in mid-2009, which consists of 220 adult patients to evaluate the safety and effectiveness of the drug in the treatment of acute pain (arising from surgery, trauma, or injury). The stock price for JAV has increased by about 24% in the last five trading days and the volume was over 2X its average on 7/20/09.

In late March, Arena Pharma (NASDAQ:ARNA) ($4.25) announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin, and the Company expects to report results from the second pivotal trial, BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), by the end of September 2009 and expects to submit a NDA for FDA approval by year-end. Vivus (NASDAQ:VVUS) ($6.85) expects to report pivotal Phase 3 clinical trial results during 3Q09 for its experimental weight loss drug Qnexa.

On 7/20/09, Orexigen Therapeutics (NASDAQ:OREX) ($7.20) announced that all three remaining Phase 3 trials evaluating Contrave (bupropion SR/naltrexone SR) met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the FDA during 1H10. Contrave was generally well tolerated by patients across the COR Phase 3 program, and the data continue to be analyzed and compiled for submission to relevant scientific conferences, peer-reviewed journals and regulatory agencies.

Hemispherx Biopharma (AMEX:HEB) ($2.49): Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) and the drug has an Orphan Drug Status with a PDUFA decision date of 5/25/09. On 5/26/09, HEB announced that the FDA advised the Company that it may require up to 1-2 additional weeks to take action beyond the original PDUFA action date of 5/25/09. Click here for an exclusive interview of HEB's CEO, Dr. William A. Carter, which was posted at BioMedReports.com on 6/12/09.

On 7/20/09, Labopharm (NASDAQ:DDSS) ($2.00) announced it has received a complete response letter (CRL) from the FDA for its new drug application (NDA) for a novel formulation (rapid onset) of the antidepressant trazodone (DDS-04A). The CRL indicates the Company's application cannot be approved in its present form due to deficiencies following an FDA inspection of the active pharmaceutical ingredient (API) manufacturing facility, which was completed 7/3/09. The FDA letter states that, "Satisfactory resolution of these deficiencies is required before this application may be approved." No efficacy or safety issues were raised by the Agency for the NDA. The API manufacturer, Angelini, has informed DDSS that it can confirm that the observations raised by the FDA are not critical and that it has not been questioned about the continued supply of trazodone to the U.S. market. Angelini intends to address the observations raised by the FDA in an action plan to be submitted to the Agency by 7/24/09.

On 6/8/09, Dyax Corp. (NASDAQ:DYAX) ($3.26) announced today that the FDA accepted the Company's submission in response to the FDA's March 2009 Complete Response Letter (CRL), which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax's BLA a new PDUFA action date of 12/1/09, which represents a six-month, Class 2 Review. In the CRL received 3/25/09, the FDA requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. Dyax believes these issues are fully addressed in its reply, which was submitted 6/1/09, and the Company's share price has increased by about 58% in the past month.

On 6/11/09, Transcept Pharma (NASDAQ:TSPT) ($4.65) announced that the FDA has informed the Company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). The Intermezzo NDA had been assigned a PDUFA action date of 7/30/09. Under this revised timeline, TSPT now anticipates action from the FDA on the NDA on or before 10/31/09. In the normal course of the Intermezzo NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions. As both the request and the TSPT response occurred late in the review cycle, the FDA has informed the company that it will extend the NDA review cycle by three months to consider the new information.

On 6/4/09, Somaxon Pharma (NASDAQ:SOMX) ($1.22) announced that it has resubmitted its New Drug Application (NDA) to the FDA for Silenor (doxepin) for the treatment of insomnia in response to a 2/25/09 Complete Response Letter (CRL) and following a 4/6/09 meeting with the FDA. The resubmission includes additional statistical analyses of the Company's clinical data relating to the durability of subjective sleep maintenance efficacy. It also includes the results of the Company's completed clinical trial of doxepin that evaluated the potential for electrocardiogram (ECG) effects. The results of that clinical trial demonstrated that Silenor had no effect on QT interval prolongation when administered at 6 mg or under exaggerated exposure conditions of 50 mg. The FDA has indicated that the review cycle for the resubmission will be six months (a Class 2 Review designation) for an estimated decision date of 12/4/09 on the Silenor NDA resubmission. Shares of SOMX have increased by about 239% over the past three months and the Company raised $6 million in a private placement in early July - providing adequate liquidity through 2Q10.

On 7/8/09, Noveko (TSE:EKO) (PINK:NKOFF) ($1.39) announced that its management recently held constructive discussions with the FDA regarding its pending 510(k) submission for the Noveko 3xEZ Antibacterial Surgical Mask to obtain clarifications on and narrow FDA's remaining data requests so that the Company can timely respond to them. As such, the Company received confirmation that it has now until 10/23/09 to submit the requested remaining data. The Company believes that when the 510(k) is cleared for the Noveko 3xEZ Antibacterial Surgical Mask, it will likely be the first mover in the U.S. market, further protected by its underlying product patent portfolio.

On 6/24/09, Cell Therapeutics (NASDAQ:CTIC) ($1.46) announced that it has completed the submission of the New Drug Application (NDA) to the FDA for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTIC requested a six-month priority review, which if granted by the Agency would result in a possible FDA decision during 4Q09. On 5/5/09, CTIC announced that pixantrone is available on a named-patient basis for use in Europe to treat patients with aggressive NHL that has either relapsed or is refractory to standard treatment options. CTIC is now awaiting a likely mid to late August response from the FDA to accept the NDA filing, rule on the status of the priority review request, and issue a PDUFA action date for pixantrone.

Nuvo Research (PINK:NRIFF) (TSE:NRI) ($0.36) has a pending NDA re-submission for Pennsaid with a PDUFA action date of 8/5/09 for a possible FDA decision. On 6/16/09, Nuvo announced a deal with Covidien (NYSE:COV) granting it exclusive rights to market and sell Pennsaid, and its follow-on product, Pennsaid Plus, in the U.S. Pennsaid and Pennsaid Plus are Nuvo's topical non-steroidal anti-inflammatory drug (NSAID) candidates that deliver diclofenac through the skin directly to the site of pain. Nuvo receives an up-front, non-refundable payment of US$10 million and is also eligible to receive a US$15 million milestone payment on Pennsaid's approval by the FDA, which will increase to US$20 million if certain labeling criteria are agreed to by the FDA.

Advanced Life Sciences (OTC:ADLS) ($0.46): Cethromycin NDA (a once-daily antibiotic for the treatment of community acquired pneumonia - CAP) with an expected PDUFA decision date of 7/31/09. On 6/2/09, ADLS announced that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining).

On 7/1/09, CombinatoRx (NASDAQ:CRXX) ($0.75) and privately-held Neuromed Pharma announced they have entered into a definitive merger agreement under which CRXX and Neuromed will merge in an all-stock transaction. Under the terms of the merger agreement, CRXX is expected to issue approximately 36 million new shares of its common stock to Neuromed stockholders with each party owning approximately 50% of the voting power of the merged organization upon closing. Relative ownership of CRXX will then be adjusted based upon the outcome of a FDA review for Neuromed's New Drug Application (NDA) product candidate, Exalgo (a once-daily, extended-release oral formulation of the opiate pain drug hydromorphone).

The rights to Exalgo have been acquired by Mallinckrodt Inc., a subsidiary of Covidien (NYSE:COV), for $15 million in upfront payments, additional development funding of up to $16 million to cover internal and external costs associated with Exalgo, an approval milestone of $30 million, which could potentially increase up to $40 million, and tiered royalties on net sales after approval. Neuromed has a pending NDA for Exalgo with the FDA, which has a PDUFA action date during 4Q09 for a possible FDA decision.

On 7/8/09, Transdel Pharma (OTC:TDLP) ($1.40) announced the successful completion of patient enrollment in a pivotal Phase 3 clinical study for Ketotransdel, which is a topical cream based non-steroidal anti-inflammatory drug (NSAID) for the treatment of acute pain. As previously announced, TDLP.OB expects to report the top-line results from this Phase 3 trial later in 3Q09. The multi-center trial is being conducted at about 30 sites in the U.S. and has enrolled over 350 patients. The primary efficacy endpoint is the change from baseline in pain intensity as measured by a Visual Analog Scale (VAS) during daily activities over the past 24 hours at Day 3. The Company also stated that it is either engaged in or pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures to support Ketotransdel in the event that the product is approved and commercialized.

On 7/8/09, Vical (NASDAQ:VICL) ($2.68) announced that its TransVax therapeutic DNA cytomegalovirus (CMV) vaccine provided promising results compared with placebo across a broad range of clinical efficacy endpoints at the four-month interim analysis in an ongoing Phase 2 trial. The trial is evaluating the potential for TransVax to prevent CMV reactivation in immunosuppressed CMV-seropositive hematopoietic stem cell transplant (HCT) recipients, which could reduce antiviral usage and CMV-associated disease. The interim efficacy data for evaluable subjects, unblinded by treatment groups, also reinforced encouraging immunogenicity data from an initial group of HCT recipients in the trial reported previously in 4Q08. Vical expects the trial to be completed during 4Q09 with final data available during 1H10.

On 11/14/08, Nephros (OTC:NEPH) ($1.25) submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. Following its review of the application, the FDA requested additional information, and Nephros replied to the Agency on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company, but a response from the Agency is still pending for the OLpur H2H Hemodiafiltration (HDF) Module and OLpur MD 220 Hemodiafilter.

Disclosure: No positions.

On 7/8/09, Spectrum Pharma (NASDAQ:SPPI) submitted a formal response to the Complete Response Letter (CRL) it received from the FDA 7/2/09 regarding its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin's Lymphoma (NHL) patients. Zevalin is currently FDA approved and marketed by SPPI for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL. The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. On 7/20/09, SPPI announced that the FDA accepted the Company's CRL resubmission for filing as a Class 1 (60-day) review with a new PDUFA action date of 9/7/09 for a possible FDA decision.

On 7/20/09, Labopharm (NASDAQ:DDSS) announced it has received a complete response letter (CRL) from the FDA for its new drug application (NDA) for a novel formulation (rapid onset) of the antidepressant trazodone (DDS-04A). The CRL indicates the Company's application cannot be approved in its present form due to deficiencies following an FDA inspection of the active pharmaceutical ingredient (API) manufacturing facility, which was completed 7/3/09. The FDA letter states that, "Satisfactory resolution of these deficiencies is required before this application may be approved." No efficacy or safety issues were raised by the Agency for the NDA. The API manufacturer, Angelini, has informed DDSS that it can confirm that the observations raised by the FDA are not critical and that it has not been questioned about the continued supply of trazodone to the U.S. market. Angelini intends to address the observations raised by the FDA in an action plan to be submitted to the Agency by 7/24/09.

On 7/20/09, Human Genome Sciences (NASDAQ:HGSI) and GlaxoSmithKline (NYSE:GSK) announced that Benlysta (belimumab, formerly LymphoStat-B) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that Benlysta plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo groups. Assuming positive results in November 2009 from a second Phase 3 trial of Benlysta, the companies plan to submit marketing applications in the United States, Europe, and other regions during 1H10.

On 7/20/09, Orexigen Therapeutics (NASDAQ:OREX) announced that all three remaining Phase 3 trials evaluating Contrave (bupropion SR/naltrexone SR) met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the FDA during 1H10. Contrave was generally well tolerated by patients across the COR Phase 3 program, and the data continue to be analyzed and compiled for submission to relevant scientific conferences, peer-reviewed journals and regulatory agencies.

On 7/20/09, Trinity Biotech (NASDAQ:TRIB) announced the submission of a CLIA application for its TRI-stat point-of-care HbA1c product to the FDA.TRI-stat is designed to measure HbA1c, also known as glycated hemoglobin, a measure of a patient's average blood sugar control over the trailing two to three month period. Utilizing a patented boronate affinity and two-phase optical system, together with a simple, fully automated, plug-and-play instrument design, TRI-stat offers highly accurate results in minutes while eliminating the need for refrigeration found with the other three competing products.

Disclosure: Long SPPI

On 3/30/09, Arena Pharma (NASDAQ:ARNA) announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin. The BLOOM results satisfied the efficacy benchmark in the most recent FDA draft guidance for the development of drugs for weight management. Lorcaserin treatment for up to two years was not associated with evidence of heart valve damage and rates for the development of echocardiographic FDA-defined valvulopathy were similar to placebo throughout the study. Arena is on track to report results from the second pivotal trial, BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), by the end of September 2009 and expects to submit a NDA for FDA approval by year-end.

Vivus (NASDAQ:VVUS) expects to report pivotal Phase 3 clinical trial results during 3Q09 for its experimental weight loss drug Qnexa. Qnexa is a once-daily, combination drug (phentermine 15 mg immediate-release + topiramate 92 mg controlled-release) in Phase 3 clinical development for weight loss in obese patients and improving blood sugar control in diabetics. Phentermine is the most widely prescribed prescription weight loss drug which is available in generic forms and has a database of 1.8 million patient years of usage.

Topiramate is better known as Topamax, which has 5.8 million patient years of use and was originally developed as a seizure drug and is also used for the prevention of migraine headaches. While both components of Qnexa will be available in generic forms, topiramate is not indicated for weight loss and the dosages being evaluated in clinical trials would make dosing difficult using the two drugs individually.

Vivus holds composition of matter and method of use patents for Qnexa as a combination treatment for obesity in the unique dosage forms being evaluated in Phase 3 clinical trials, with more than 4,500 patients currently enrolled in late-stage studies for weight loss and Type 2 diabetes control. Last year, Vivus reported results for Qnexa from the 28-week EQUATE Phase 3 clinical trial which met its primary endpoint by demonstrating superior weight loss with both the full-dose and mid-dose of Qnexa, as compared to the drugs used individually and placebo.

On 7/20/09, Orexigen Therapeutics (NASDAQ:OREX) announced that all three remaining Phase 3 trials evaluating Contrave (bupropion SR/naltrexone SR) met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the FDA during 1H10. Contrave was generally well tolerated by patients across the COR Phase 3 program, and the data continue to be analyzed and compiled for submission to relevant scientific conferences, peer-reviewed journals and regulatory agencies.

OREX is continuing to follow patients in a Phase 2b clinical trial of Empatic (zonisamide SR/bupropion SR), ZB-202. The trial is designed to build on the results from a previous Phase 2b trial of Empatic, ZB-201. In the current trial, which measures weight loss after 24 weeks of treatment, two different dosages of Empatic are being studied along with the individual constituents. The Company expects to report results from this Phase 2b clinical trial during 3Q09.

EnteroMedics (NASDAQ:ETRM) is developing implantable systems to treat obesity and other gastrointestinal disorders. VBLOC Therapy intermittently blocks nerve signaling between the brain and stomach over the vagus nerves using high-frequency, low-energy electrical impulses. The vagus nerves are known to control digestive functions including food processing and feelings of hunger and fullness. In blocking nerve function, VBLOC is designed to help patients feel hungry less and feel full sooner, therefore reducing how much they eat.

The effect of VBLOC Therapy has been demonstrated in early clinical trials, where patients reported reduced time to feelings of fullness at meals, as well as reduced feelings of hunger between meals out to six months with resultant reduced calorie intake. The EMPOWER study is a randomized, double-blind, placebo-controlled pivotal clinical trial that reached its target enrollment of 294 patients in September 2008. ETRM expects results from the blinded portion of the study during 2H09, which will be used for a Premarket Approval (PMA) Class III medical device submission to the FDA for marketing clearance.

On 6/8/09, NeuroSearch (CPH:NEUR) announced that it has successfully completed its End of Phase 2 meeting with the FDA for tesofensine, a monoamine reuptake inhibitor in development as a novel treatment for obesity (weight management). The FDA endorses the overall Phase 3 plan for tesofensine in obesity, including the filing of an NDA based on 12 months safety and efficacy data. NeuroSearch will now finalize Phase 3 preparations and an SPA (Special Protocol Assessment) request for submission to the FDA, while continuing discussions with potential license partners.

The main conclusions from the End of Phase II discussions with the FDA include the following: (1) The proposed dose regimen of 0.25 mg or 0.5 mg tesofensine daily in Phase III was endorsed. (2) The proposed pivotal Phase 3 program for tesofensine in weight management was endorsed by the FDA and will consist of four placebo-controlled clinical studies, comprising a total of approximately 5,700 obese patients with and without co-morbidities (such as Type 2 diabetes, hypertension and dislipidemia). (3) Two of the four trials are powered to show superior weight loss effectiveness for tesofensine compared to sibutramine (marketed as Reductil and Meridia). (4) The safety and efficacy assessment within and across the Phase 3 studies and the filing of the NDA for tesofensine for weight management based on 12 months data were also endorsed by the FDA.

Earlier results from a Phase II Proof of Concept study with tesofensine in obesity, TIPO-1, has shown a placebo-corrected average weight loss of approximately 10% after 24 weeks of daily treatment with 0.5 mg tesofensine. The results from TIPO-1 have been published in The Lancet (The Lancet, Volume 372, Issue 9653, Pages 1906-1913, 29 November 2008) with the conclusion that tesofensine produces a weight loss at least twice that of currently approved anti-obesity drugs. The safety data base for tesofensine includes more than 1,500 patients having been exposed to treatment with tesofensine and hereof more than 1,300 on relevant dosing.

Disclosure: No positions

"While it was always unrealistic to expect continued uninterrupted improvement in economic indicators, in particular as the recovery in some series had broken previous records, the confluence of these negative releases comes at a sensitive time when markets have begun to question underpinnings of the six-month long equity rally and when the sustainability of the broader recovery remains in question," said Michael Hart, a currency strategist for Citigroup, in a note to clients.

In healthcare, shares of Caraco Pharmaceutical Laboratories Ltd.(AMEX:CPD) shot up 20% to $5.09 +0.88, to lead healthcare stocks on Wednesday. The company agreed to a consent decree that allows them to resume operations at its Detroit plant if it receives a written notice from the FDA and independent experts monitoring its compliance with manufacturing regulations. Senomyx Inc.(NASDAQ:SNMX) shares rose to $4.03+0.28 (7.47%) thanks after analyst Andrew Vaino with Roth Capital Partners initiated coverage with a "buy" rating and a 12-month price target of $5. Most biomedical investors had never really heard about the company, because while they are focused on using taste receptor-based assays, they spend most of their time on screening technologies to discover and develop flavors, flavor enhancers and bitter blockers for the packaged food, beverage and ingredient supply industries.Sucampo Pharmaceuticals, Inc.(NASDAQ:SCMP), a bio-pharmaceutical company focused on the discovery, development and commercialization of its own drugs based on prostones, a class of compounds derived from functional fatty acids that occur naturally in the human body saw it's shares rise modestly to $5.83 +0.31, but on a day when most stocks closed in the red it was good enough to get them into the top 5 gainers list. Two weeks ago they started an internal shuffling of the staff. Shares of the company had traded as high as $7.71 as recently as early August, right before the company posted a quarterly loss and sent shares down a slanting slope to a low of $4.58 a month later when the company withdrew its application to market in Europe its drug for chronic constipation. Shares have been rising unsteadily since then.

Shares of Orexigen Therapeutics, Inc.(NASDAQ:OREX) gained ground Wednesday on positive midstage study data for its obesity drug candidate Empatic. The company said the obesity drug candidate met treatment goals in a midstage study. Empatic reduced the weight of study subjects by 9.9 percent, according to Orexigen. The company filed an SEC form 8-K which you can find here. Shares of VIVUS, Inc.(NASDAQ:VVUS) rose, too, as investors appeared to discount Empatic as a threat to the company's own obesity drug candidate, Qnexa.Shares of BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) managed to climb out of a hole early in the day to $8.24+0.06 (0.73%) after the company released news that was met with a bit of skepticism by some experts in the biotech community. According to some on the street, BioCryst had been searching for a deal to raise capital when their stock was trading between the $12 and $13 level, but share prices started to work against them when word of possible dilution leaked and mild fear hit the stock- which has been on a downward slope since. Even a September 21st press release announcing that the company had been awarded an additional $77.2 million modification to it's BARDA (Biomedical Advanced Research and Development Authority) contract failed to stop the slow downward slide. Those BARDA funds were originally given to the company by the U.S. Department of Health & Human Services in 2007 as part of an effort to complete development of Peramivir, an anti-viral agent for the treatment of complicated influenza. While today's news included some quoted references to H1N1, some industry insiders were confused since the studies had been previously described as focusing on patients hospitalized due to "serious influenza" and not just H1N1 (Swine Flu). Dr. Frederick G. Hayden, a virologist at the University of Virginia, said recently that intravenous administration "gives a high concentration in the plasma rapidly and makes a lot of sense." But he added that Peramivir did not appear to work that well against infections resistant to Tamiflu. It will be interesting to see if this news finally breaks the shares out of their descending trend. The company said it will start two trials by the end of this year and they are expected to be complete in mid-2011.Shares of Sequenom, Inc.(NASDAQ:SQNM) may have finally hit bottom at $3.23 -0.23 (-6.65%) since shares started to show some very modest signs of life after hours. After the market closed on Monday, the diagnostics firm fired a slew of key execs after an investigation revealed mishandled test data. Here are the rest of Wednesday's Top Gainers and Losers:

Gainers (% price change) Last Trade Change Mkt Cap Caraco Pharmaceutical CPD 5.09 +0.88 (20.90%) 198.97M Senomyx Inc. SNMX 4.03 +0.28 (7.47%) 124.60M The Aristotle Corporation ARTL 5.73 +0.35 (6.51%) 102.93M Sucampo Pharmaceuticals SCMP 5.83 +0.31 (5.62%) 243.95M 3SBio Inc. (ADR) SSRX 11.00 +0.51 (4.86%) 236.64M Losers (% price change) Rockwell Medical Tech RMTI 7.78 -1.22 (-13.56%) 110.54M Dyax Corp. DYAX 3.59 -0.48 (-11.79%) 260.17M Lannett Company, Inc. LCI 7.48 -0.76 (-9.22%) 183.39M Jazz Pharmaceuticals, Inc JAZZ 8.02 -0.69 (-7.92%) 248.39M Sequenom, Inc. SQNM 3.23 -0.23 (-6.65%) 197.54M Most Actives (dollar volume) Pfizer Inc. PFE 16.52 -0.25 (-1.49%) 111.50B Wyeth WYE 48.58 -0.07 (-0.14%) 64.86B Johnson & Johnson JNJ 60.89 -0.04 (-0.07%) 167.80B Merck & Co., Inc. MRK 31.63 -0.22 (-0.69%) 66.70B Schering-Plough Corp. SGP 28.25 +0.12 (0.43%) 46.16B

The BioMedReports.com FDA Calendar database includes over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results. My FDA Calendar Extreme Trades article series highlights companies with market caps below $1 billion and / or single digit stock prices with pending catalysts in the form of FDA decisions, clinical trial results, and other FDA filings / re-submissions that are expected to have a major percentage impact on the underlying share prices of the affected companies.

Two general Bio-Catalyst Extreme Trading Strategies are outlined below and as with previous installments this article is not an endorsement of the companies profiled or a complete list of extreme trades included in the FDA Calendar database. Please note neither strategy outlined below recommends holding the extreme trade stocks through the actual binary event to mitigate the downside risk; although it is also possible to let some profits ride through the event for a winning position if so inclined.(1) buying a basket of stocks highlighted in extreme trade reports well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume with a goal of achieving possible returns of 50-100% without the risk of holding through the binary event; and(2) momentum / day trading strategies for the stocks highlighted in my extreme trade reports in the days / weeks ahead of the expected binary event – taking advantage of the greatly increased stock price volatility and trading volume.The stock prices for the FDA Calendar Extreme Trade stocks reflect intraday trading on the morning of 10/13/09 at the time of finalizing this report for publication and the companies are presented in alphabetical order by company name. A total of 85 companies are profiled in the extreme trade report today, with the majority of companies trading at below $5 per share, including free samples from the report for 10 companies with recent updates and / or possible near-term catalysts.

Click here for more information on becoming a premium subscriber at BioMedReports.com, which includes access to the full report on the extreme trades in the report today and access to the FDA Calendar database of over 400 entries.On 7/23/09, Access Pharma (OTC: ACCP.OB) ($3.41) announced that its European partner, SpePharm, is collecting data from a post-approval marketing study of MuGard in head and neck cancer patients undergoing radiation treatment in the UK showing prevention of oral mucositis (OM). In a multi-center study expected to enroll a total of 280 patients, patients are provided with seven weeks of MuGard therapy, and begin using MuGard one week prior to radiation treatment and then throughout the subsequent six weeks of planned therapy. The first 140 patients being treated in this assessment study have been enrolled and treated, and as of the time of the update, none of these patients have experienced any OM.The encouraging interim results thus far for MuGard in the first 140 patients include some that have completed all seven weeks and others who are still pending completion in the study, and the final numbers for all 280 patients enrolled in the study are expected during early 4Q09. Also, MuGard is being evaluated in about 1,000 patients in Europe (Germany, Italy, U.K.) by SpePharm in multiple post-marketing studies that include 7-week treatment cycles, and a steady stream of data is expected by Access through year-end 2009.On 7/28/09, Cardium Therapeutics (AMEX: CXM) ($1.94) and its subsidiary Tissue Repair Company provided an update on the completion of their MATRIX Phase 2b clinical study and announced plans to provide detailed safety and efficacy data for their Excellarate product candidate around the end of September. The MATRIX trial, a prospective, randomized, double-blind, placebo-controlled study, has enrolled 124 diabetic patients with non-healing, lower extremity neuropathic ulcers.The companies also reported that results from the MATRIX clinical study are expected to be used to support additional studies and applications of Tissue Repair's Gene Activated Matrix (GAM) technology for ulcers and other potential applications, including not only the repair of soft tissue injuries such as diabetic or pressure ulcers, but hard tissue injuries such as those affecting bone. On 8/25/09, CXM announced that all patients enrolled in the MATRIX clinical study have now completed their initial 12-week evaluation period. On 10/1/09, CXM announced that it expects to receive the locked unblinded data set and be in position to announce preliminary results on or before 10/14/09.On 5/27/09, Cytori Therapeutics (NASDAQ: CYTX) ($3.50) announced that it completed enrollment in the first study to investigate adipose derived stem and regenerative cells in chronic heart disease. The trial, which has been named the PRECISE study, was carried out at leading cardiology centers in Europe. It specifically enrolled patients suffering from an advanced form of chronic heart disease, known as chronic myocardial ischemia, for which there is no generally accepted treatment. The trial enrolled 27 patients and was designed as a double-blind, randomized, placebo controlled, dose escalation study. The primary objectives of the study were to assess safety and feasibility of Cytori’s Celution System as part of a novel procedure for chronic heart disease. The Company believes it will be able to fully assess these primary objectives with the data obtained from 27 patients (the protocol allowed for up to 36 patients). Further, the independent data safety and monitoring board had not identified any safety concerns relating to the Celution output or the procedure. Six month results are expected during 1H10.On 5/28/09, Cytori announced the publication of the first preclinical study to demonstrate ADRCs significantly improved cardiac function after a heart attack. The APOLLO study is the first clinical trial to investigate uncultured adipose-derived stem and regenerative cells in heart attacks in human patients. Enrollment was recently completed in APOLLO, a double blind, placebo controlled, safety and feasibility trial. Data from this study is expected to be reported during 1Q10.On 9/9/09, Cytori announced its fall medical conference presentation schedule, including the San Antonio Breast Cancer Symposium (December 9-13) presentation of (1) interim, rolling six-month results on patients from the RESTORE-2 study and (2) preclinical data will be presented on the mechanisms by which ADRCs safely enhance fat grafting. Cytori expects to present six-month data for 15-30 patients while final, 12-month data on all patients is expected in early 2011. The ClinicalTrials.gov identifier is NCT00616135 for the RESTORE-2 study, which is a European study designed to evaluate the transplantation of ADRC-enhanced autologous (patient-derived) fat tissue into and around breast deformities. Data from this post-marketing study will also be used to support market adoption and insurance reimbursement for the procedure.Later this week, data from an investigator-initiated (Dr. Yamamoto, Nagoya University) study evaluating ADRCs for the treatment of stress urinary continence (SUI) is scheduled to be presented at the 7th Annual Meeting of the International Federation for Adipose Therapeutics and Science (IFATs 2009, October 15-17 in Korea). I will upload and share any details or presentation files for this data such as the study abstract after the event if possible. Also, Cytori expects to clarify the FDA medical device regulatory path for the Celution 700 System (e.g. 510k or PMA) early next year.On 8/31/09, Delcath Systems (NASDAQ:DCTH) ($5.60) announced the FDA granted orphan drug status to doxorubicin, an approved chemotherapy agent, for the treatment of primary liver cancer. The Company said it tested doxorubicin with its unique drug delivery technology, Percutaneous Hepatic Perfusion (PHP), which results in significantly higher doses (e.g. 10X the FDA approved standard dosing with 100X exposure of drug to the tumor site) of anti-cancer drugs such as doxorubicin to the liver without exposing the patient's entire body. Delcath plans to carry out the necessary clinical work for a regulatory submission of PHP with doxorubicin. On 8/25/09, DCTH reported that it has exceeded 90% enrollment for its pivotal Phase 3 Metastatic Melanoma Trial which will enroll a total of 92 patients.This study is testing the PHP System for the regional delivery of melphalan to the liver to treat patients with metastatic melanoma (a deadly type of skin cancer) who have tumors in the liver, which cannot be removed by surgery (unresectable). On 9/11/09, DCTH reported that the Data and Safety Monitoring Board (DSMB) reviewed clinical data on 77 patients enrolled in its pivotal Phase 3 clinical trial and unanimously recommended that the trial continue to enroll patients with the goal of reaching the 92 patients required to complete the study. DCTH expects enrollment to be completed by mid-October and is still on track for a FDA filing by mid-2010.On 7/7/08, the FDA accepted for review Hemispherx Biopharma’s (AMEX: HEB) ($1.81) NDA for Ampligen to treat chronic fatigue syndrome (CFS), which was originally submitted in October 2007. The NDA for Ampligen (poly I : poly C12U) is also the first ever accepted for review by the FDA for systemic use of a toll-like receptor therapy to treat any condition and there are currently no FDA-approved treatments for CFS. On 2/18/09, HEB was notified by the FDA that the originally scheduled PDUFA action date was extended by three months to 5/25/09. On 5/22/09, HEB was notified by the FDA that it may require up to one to two additional weeks to take action beyond the scheduled PDUFA action date. However, since that date, no further notification has been received from the FDA.On 10/9/09, BioMedReports.com conducted an interview with HEB’s CEO, Dr. William Carter for an update on the Ampligen NDA status. Dr. Carter stated that HEB expects to complete a set of preclinical toxicology reports during 4Q09. In addition, the Agency has conducted inspections of manufacturing facilities over the past 12 months which required no corrective actions by HEB. However, the FDA noted certain compliance issues with “fill and finish” facilities and took corrective actions with its own facilities in NJ and is about to complete remediation actions in the next several weeks in the contract lab in WA with a report to the FDA pending. In addition, animal toxicology studies conducted by Lovelace Respiratory Research Institute in NM in support of the Ampligen NDA and at the request of the FDA are currently undergoing auditing and expected to be completed by late 2009 to early 2010.ImmunoCellular Therapeutics (OTC: IMUC.OB) ($1.08) is developing an off-the-shelf (i.e. does not require obtaining cells from the patient as part of the manufacturing process) peptide-based, cancer stem cell vaccine / immunotherapy (ICT-121) which targets a protein marker called CD133 that is over-expressed on cancer stem cells. The Phase 1 study for ICT-121 will involve 20 patients with glioblastoma (GBM is a deadly type of brain cancer) receiving five treatments each with final data from the trial anticipated after about 18 months (e.g. 3Q11), since the median time to recurrence in GBM patients is only 6.9 months.ICT-121 may also be beneficial to patients with pancreatic, lung, colon, renal, melanoma, and breast cancers. Early next year (1Q10 which ends 3/31/10), IMUC expects to make an IND filing with the FDA for permission to begin human clinical trials for a Phase 1 study of its off-the-shelf cancer stem cell vaccine candidate (ICT-121). IND Filings for ICT?121 are expected for Brain Tumors in US or Europe during 1Q10 while IND Filings for ICT?121 for Pancreatic Cancer are expected in the US or Europe during 3Q10.IMUC is also developing a Dendritic Cell (DC) Based Cancer Antigen Vaccine (ICT?107) to Treat Glioblastoma (GBM, the most common / aggressive form of brain cancer). A Phase I GBM trial was initiated in May 2007 with a goal of determining the safety and immune response of patients. The DC vaccine targets six glioma?specific peptides including targets highly expressed on cancer stem cells. In the study, 19 patients (16 newly diagnosed and 3 recurrent) treated with no serious adverse events and patients received three vaccinations at two weeks apart.In addition, 43% of newly-diagnosed patients experienced no tumor recurrence with median progression free survival (PFS) of 14.6 months versus just 6.9 months for the standard of care treatment for GBM. Overall PFS in the trial was 12 months while three patients experienced PFS / OS (overall survival) of greater than two years. Initial data was presented earlier this year at ASCO. No grade 3 or 4 toxicities were reported in the Phase 1 trial. The next update on clinical data will be reported at the Congress of Neurological Surgeons on 10/26/09. Potential partnering of ICT?107 may occur in 2010 as IMUC to fund future clinical development as IMUC retains ICT-121 for in-house clinical development.VGX-3400 is a proprietary, prophylactic DNA vaccine candidate being developed by Inovio Biomedical (AMEX: INO) ($1.46) to prevent infection with the avian influenza (H5N1). The vaccine is being delivered using Inovio's CELLECTRA DNA Delivery System. The plasmid vaccine is delivered into muscle tissue with the assistance of electroporation with the goal of achieving expression of the H5N1 influenza antigens. Inovio expects to initiate a Phase I clinical trial for this DNA vaccine in Europe before year end and the Company’s clinical team is fulfilling information requests from the FDA relating to its previously-filed IND. Based on my 10/7/09 phone interview with the Company’s investor relations contact, Bernie Hertel, Inovio could potentially receive a FDA response on the IND by year-end and begin a Phase 1 clinical trial for VGX-3400 in humans during 1Q10.On 10/5/09, Inovio announced interim safety / immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation. The vaccine was found to be generally safe and well tolerated, and achieved significant cellular and humoral immune responses at the lowest dose administered. This Phase I clinical trial is designed to test the safety and immunogenicity of VGX-3100 in women with a previous history of cervical intraepithelial neoplasia (CIN) 2/3, a precursor lesion prior to the development of cancer.This dose-escalation study is enrolling patients in three cohorts of six subjects each with DNA vaccine doses at 0.6 mg (0.3 mg each of two DNA plasmids), 2.0 mg, and 6.0 mg. The immunization regimen consists of each subject receiving three immunizations at the indicated dose. The vaccine is delivered using Inovio’s proprietary CELLECTRA intramuscular electroporation delivery device. The VGX-3100 clinical trial is now enrolling the second cohort of six patients. Inovio expects full enrollment of all three cohorts during 1H10 and full analysis of immunogenicity / safety data by 3Q10. In addition, interim results on the second cohort of six patients are expected during 1Q10.On 9/21/09, Mentor Capital (OTC: MNTR.PK) ($1.55) completed its FY08 audit in preparation for filing a self-registration statement with the SEC and applying to move from the Pink Sheets to begin being quoted on the Over-the-Counter Bulletin Board (OTCBB) system. The move to the OTCBB was accelerated by the Company’s acquisition of a significant interest in Quantum Immunologics (click on preceding link for QI’s News Room page and more details on the clinical trial) in early July, which is a privately held cancer immunotherapy company now in Phase I/II metastatic breast cancer trials.At year end, Mentor Capital had $1.25 per share in securities or financial assets which included $0.32 or $173,259 in cash against $34,823 in total non-shareholder liabilities along with 546,117 shares outstanding as of 12/31/08. During the year, earnings per basic MNTR share were $0.16. At the close of 2008, 1,386 shareholders held 28,218,840 freely tradable stepped warrants at $1, $3, $5 and $7 per share exercise prices. Upon call and exercise, the eventual expected warrant proceeds calculate to approximately $145 million. In a subsequent event, 83% of the $1 warrant proceeds were pledged to QI in exchange for 20% of the cancer fighting company private stock, with funds primarily being used to finance their FDA trials.QI originally filed with the FDA for authorization to conduct a Phase I safety trial, but the Agency recommended a combination Phase I/II trial to expedite the clinical development process. Phase I = 3 patients (safety); Phase II = 24 patients (safety and efficacy); patients will receive three OFA-loaded activated DC injections under the skin at monthly intervals to evaluate safety/toxicity, immune response (induction of OFA specific T-lymphocytes), objective clinical responses, time to disease progression, and survival. The Phase I/II trial of QI’s DC immunotherapy that targets OFA-iLRP (oncofetal antigen / immature laminin receptor protein) for Stage IV breast cancer patients is underway with preliminary results expected in January 2010 and final data expected by May 2010.Momenta Pharma (NASDAQ: MNTA) ($9.50) is partnered with the Sandoz division of Novartis (NVS) to develop a generic equivalent (M-Enoxaparin) of the multi-billion dollar injectable blood thinner Lovenox ($3.9B in worldwide sales for 2008). While MNTA + NVS were not the first to file for a generic version of Lovenox, the 180-day exclusivity period awarded to the first-to-file company already expired on 4/1/09 for Amphastar + partner Watson Pharma (WPI). The other company with a pending ANDA for Lovenox is TEVA, which is also involved in litigation with Sandoz over the Copaxone ANDA.In late 2007, all three applicants with ANDAs for Lovenox received a request for more information from the FDA on the immunogenicity of their products. 9/26/08 is the date that Sandoz submitted its complete response to the FDA for the abbreviated new drug appplication (ANDA). The Generic Drug Division does not issue decision date deadlines, but MNTA provided guidance in Sept. 2009 for a possible decision on the ANDA by year-end 2009 and believes the Agency has all necessary info to make a decision, including FDA inspections of China heparin sources and a processing plant in Austria that are utilized by Sandoz in the manufacturing process.On 9/8/09, Protox Therapeutics (TSX: PRX.TO) (OTC: PTXRF.PK) (US$0.58) announced that it has completed patient enrollment in a multi-center, double-blinded, placebo-controlled Phase 2b study (TRIUMPH) of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH), a common and bothersome urological condition that affects more than 50 million men worldwide. The Company recently provided guidance for reporting top-line results from the TRIUMPH study during 4Q09. TRIUMPH is the third BPH clinical trial of PRX302 conducted by Protox. In addition to being well-tolerated, the previous open-label Phase 2 study reported at the 2009 Annual Meeting of the American Urological Association, showed an 11 point improvement in the International Prostate Symptom Score at the optimal PRX302 dose used in the TRIUMPH study.PRX302 is the lead drug in the company's PORxin(TM) technology platform. PORxin drugs are pore-forming pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from BPH and prostate cancer. Once activated, the drug punches holes in the cells causing the contents to leak out and ultimately cell death.On 9/10/09, Protox announced positive 12 month data from its open-label Phase 2 study of PRX302 in males with moderate to severe benign prostatic hyperplasia (BPH). The study results indicate that those patients who received an optimal dose of PRX302 continued to demonstrate significant symptomatic relief at 12 months following a single treatment. Detailed 12-month results from this Phase 2 open-label clinical trial will be presented at the 30th World Congress of the Societe Internationale d'Urologie from November 1-5, 2009.Click here for more information on becoming a premium subscriber at BioMedReports.com, which includes access to the full report on the extreme trades in the report today and access to the FDA Calendar database of over 400 entries.Below are a dozen major stock price gainers (stock price data current through intraday trading on 10/13/09) from my previous extreme trade article series, which are the reason I prefer investing in a basket of these type of stocks with the hope of picking at least one of the big gainers which can more than offset any inevitable decliners or stocks with flat returns.Pending FDA Decisions: 20 Extreme Trades – 6/22/091.) NeurogesX (NASDAQ:NGSX) was at $5.86, now at $8.112.) Salix Pharma (NASDAQ:SLXP) was at $9.91, now at $22.933.) Dyax Corp. (NASDAQ:DYAX) was at $2.00, now at $3.384.) Somaxon Pharma (NASDAQ:SOMX) was at $1.00, now at $2.295.) Human Genome Sciences (NASDAQ:HGSI) was at $2.58, now at $18.70Pending Clinical Trial Results: Ten Extreme Trades – 5/14/096.) Orexigen Therapeutics (NASDAQ:OREX) was at $3.11, now at $8.977.) Jazz Pharma (NASDAQ: JAZZ) was at $0.82, now at $7.90NeurogesX Awaiting Dual Regulatory Decisions – A Dual Extreme Trade on 5/10/098.) NeurogesX (NASDAQ: NGSX) was at $2.87, now at $8.1412 Extreme FDA Trades on New Product Decisions – 4/9/099.) Vanda Pharma (NASDAQ: VNDA) was at $0.93, now at $12.3010.) Hemispherx Biopharma (AMEX: HEB) was at $0.51, now at $1.8211.) Transcept Pharma (NASDAQ: TSPT) was at $2.85, now at $14.00Extreme FDA Trades on Pending Medical Device Decisions – 5/25/0912.) Nephros (OTC: NEPH.OB) was trading at $0.14, now at $1.25Disclosure: Long ACCP.OB, CYTX, IMUC.OB, INO, MNTA, MNTR.PK, PTXRF.OB.See my full disclaimer at MikeHavRx.com (bottom of any page).

For the week of April 23, 2007

Mr. Gaskins keeps the bar firmly high for 2007 IPOs. With market conditions seemingly better the companies coming to market just keep rolling on. But will investors find great opportunity with these offering? Gaskins presents his analysis if recent offerings and those just around the bend.

Companies listen in this report are as follows; noting their grade and IPO Hardball rank.
CardioMEMS (SENS) a wireless sensors for cardiovascular systems company: C+, 8

Cinemark Holdings (CNK) who operates 392 movie theaters: C+, 7

EDENOR (END) a large electricity distribution company in Argentina: C+, 7

EndoCeutics (ENCX) who develops hormones for cancer & endocrine disorders: C, 5

OceanFreight (OCNF) a startup shipper seeking to acquire ships: C+, 6

Ocean Power Tech (OPTT) an energy company developing technology to pull electricity from ocean waves: C, 6

Orexigen (OREX) who is developing central nervous system disorder treatments: C, 7 Pharmasset (VRUS) creating hepatitis, HIV oral therapeutic treatments: C, 6

Vaughan Foods (FOOD) a regional food processor and packager: C, 5

Also covering in this cast is a recap of last week's prospects (PCS) (DEEP) (SCR)

This week Mr. Gaskins provides analysis of Comverge (COMV) a company that increases grid reliability for the utility industry.

Description of Business:
Load management, demand response systems for utilities to increase available electric capacity through reduced energy consumption during periods of peak energy demand . Markets itself as a 'clean energy alternative' but that is somewhat of a misnomer, because COMV is in the business of providing grid management & demand response systems . As a result of investments in Virtual Peaking Capacity (VPC) programs (see below), revenue from COMV's Alternative Energy Resources Group has represented an increasing percentage of total revenue, growing from 7% of total revenue for the year ended December 31, 2004 to 52% of total revenue for the year ended December 31, 2006.

Strategic alliance with Air Products and Chemicals, who has (APD) as a stockholder. The alliance for developing business models to jointly recruit large commercial and industrial customers of Air Products as participants in COMV's Virtual Peaking Capacity (VPC) programs;

For the week of April 16, 2007 Mr Gaskins will be covering the following:
MetroPCS Communications (PCS)
Simcere Pharmaceutical (SCR)
Superior Offshore International (DEEP)


For the week of April 23, 2007 Mr Gaskins will be covering the following:
CardioMEMS (SENS0
Cinemark Holdings (CNK)
EDENOR (END)
Ocean Power Tech (OPTT)
OceanFreight (OCNF)
Orexigen (OREX)