Below are 12 extreme FDA trades for 11 companies with market caps below $200M which have pending new drug product decisions or other meetings/milestones scheduled with the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced. 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.com.

Hemispherx Biopharma [HEB: 1.36, -0.10 (-6.85%)]: 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

ARCA Biopharma, Inc.

(Public, NASDAQ:ABIO)

Heart failure has always been one of the predominant fatal human conditions, therefore this week I will be focusing on a company which has developed a highly successful treatment.

The broad world market for this drug is truly spectacular.

Key Facts: Heart failure becomes more common with increasing age. About 1 in 35 people aged 65-74 years have heart failure. This increases to about 1 in 15 of people aged 75-84 years, and to just over 1 in 7 people aged 85 years and above. It is uncommon in younger people.

It is difficult to give an outlook (prognosis) for an individual. In general, the more severe the heart failure, the worse the outlook. In many cases, the symptoms remain at a stable level for quite some time (months or years) before becomming worse. In some cases the severity

Acusphere, Inc.

(Public, OTC:ACUS)

Continuing the FDA journey to riches, I have chosen ACUS as my next prime target. I see alot of benefit and potential in this company, not only from its currently cheap PPS, but also from the vast potential market. The time is now to load up on this company (if you haven’t already done so) while the price is still at a discount. I expect big things to come within the next two weeks, so fasten your seat belts and let your portfolio fly.

About: Acusphere, Inc. is a specialty pharmaceutical company that develops drugs and formulations of existing drugs using its porous microparticle technology. This technology enables the Company to control the size and porosity of particles, including nanoparticles and microparticles, so that the particles can be customized to address the delivery needs of a variety of

Shares of Vanda Pharma [VNDA: 7.87, +6.79 (+628.70%)] soared by nearly nine-fold in after-hours trading Wednesday evening as Fanapt (iloperidone) was approved by the FDA for the acute treatment of adult patients with schizophrenia. The approval was supported by two placebo-controlled Phase 3 clinical studies comparing Fanapt to placebo and active control in patients with schizophrenia, as well as safety data in more than 3,000 patients.

Below are the nine remaining companies from my article last month on a dozen extreme FDA trades of companies with market caps below $200M which have pending new drug product decisions at the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced.

1.) Vion Pharma [VION: 0.00, N/A (N/A)]: Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as

Below are 12 companies with market caps below $200M which have pending new drug product decisions at the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced.

BioMedReports.com FDA Calendar

1.) Vion Pharma (VION.OB): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA (filed with the FDA on 2/17/09) with priority review request as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). 4/17/09 is date for FDA to accept the filing and rule on priority review request - if granted the PDUFA would be 8/17/09 instead of 12/17/09 for standard 10-month review.

2.) Discovery Labs (DSCO): Surfaxin (lucinactant) NDA for prevention of respiratory distress syndrome (RDS) in premature infants. DSCO received its third approvable letter for Surfaxin last

Nuvelo, Inc. (NUVO) is a biopharmaceutical company that makes drugs for acute cardiovascular and cancer therapy. On September 25, the San Carlos, California-based company announced that it has entered into a definitive merger agreement with privately held ARCA Biopharma, Inc. Under the terms of the agreement, ARCA will become a wholly owned subsidiary of Nuvelo.

The deal will result in the creation of a late-stage biotechnology company which will focus on the treatment of cardiovascular diseases. This deal makes sense for both companies in our view. While Nuvelo will get the chance to transform itself into a late-stage biotech company, ARCA should be able to put NuveloÂ’s significant cash balance to good use towards the commercialization of its lead pipeline candidate, Gencaro, which is currently under FDA review for the treatment of chronic heart failure.

The transaction is expected to close later this year/early next year, subject to customary