With the World Health Organization (WHO) officially declaring the flu a pandemic of phase 6, one company looking to make waves is Hemispherx BioPharma (AMEX:HEB).

Hemispherx has recently been in limbo awaiting FDA decision on the long-awaited treatment for Chronic Fatigue Syndrome (CFS), Ampligen.

Ampligen, also known as poly I:poly C12U, is an experimental immunomodulatory double stranded RNA drug developed by HEMISPHERx Biopharma of Philadelphia, Pennsylvania. Ampligen was first synthesized in the 1970s and has been proposed and tested as a treatment for many illnesses, but primarily chronic fatigue syndrome (ME/CFS) and acquired immunodeficiency syndrome (AIDS).

Summary of articles

Identifying Fact vs. Fiction on Hemispherx’s Ampligen

Hemispherx Ampligen Combats H5N1

Post Approval Hemispherx Ampligen PPS Evaluation

Conference Call - Hemispherx Responds to TheStreet.com

Hemispherx Fights Back Against Feuerstein

Conference Call

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

Today I have some exciting news to share with you all. Due to the influx of emails I have been receiving lately on inquiries regarding the latest FDA deadlines on (Public, AMEX:HEB) and (Public, OTC:ACUS), StocksHaven Investments alongside BioMedReports.com will be hosting video and phone conferences with their investor relation spokespersons. Rest assured the conversations will be recorded in real-time with no editing what so ever. I believe this will prove to be a new and ingenious implementation which will in turn help us stand apart from other financial publications.

Here is a copy of the e-mail sent out to HEB’s investor relations on May/12/09:

My name is Michael Vlaicu and I am the founder, and lead investment analyst of a highly successful financial blog and equity advice company. I would like to express my gratitude for

Due to the explosive demand for BioPharma companies pending Food and Drug Approval on new and innovative drugs, I will begin focusing on companies which are a few weeks away from their reviews. Taking notice of the recent 3000%, and 1000% over night gains respectively of TTNP and VNDA, the risk versus rewards leans well towards the positive end on these choices.

Moreover, for those who are not high on risk tolerance, investing up to the FDA approval date may still be a very smart investment as these companies are poised to rise leading up to the decision.

Risk: You lose up to 40% as seen from DSCO and VION.OB and NFLD if approval is declined.

Now let’s move onto my first choice:

Hemispherx BioPharma, Inc

(Public, AMEX:HEB)

About: Hemispherx Biopharma, Inc.

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