"~FAnTA$tic DD ~"

[RonnieD]

ABIO is down because it's risen very high in anticipation of the FDA ruling, and it laid off 40 employees and will take a charge for that.. but touching ABIO long or short now is just a risky bet on what the FDA will do.

Arca biopharma (NASDAQ:ABIO): Gencaro (bucindolol) NDA for the treatment of chronic heart failure with a PDUFA decision date of 5/31/09 (please note this date is a Sunday so Monday 6/1 is the more likely date for an announcement or update on the FDA decision). ABIO also has a collaboration with LabCorp (LH) and a pending PMA for a genetic test which is designed to be used in conjunction with Gencaro. ABIO has identified genetic traits which the Company believes will predict patient responses to the drug and hopes to launch both as a personalized medicine combination to optimize treatment outcomes

ARCA is a biopharmaceutical company whose principal focus is developing genetically-targeted therapies for heart failure and other cardiovascular diseases.

ARCA’s lead product candidate is GencaroTM (bucindolol hydrochloride), a pharmacologically unique beta-blocker and mild vasodilator, which is under review by the U.S. Food and Drug Administration, or FDA, for chronic heart failure, or HF. Gencaro is an oral tablet formulation, dosed twice daily. ARCA has identified common genetic variations, or genetic markers, that it believes predicts patient response to Gencaro. Subject to approval by the FDA, ARCA, through its collaboration with Laboratory Corporation of America, or LabCorp, anticipates introducing a test for these genetic markers with the market launch of Gencaro, potentially making Gencaro the first genetically-personalized cardiovascular drug. When prescribed using the test for these markers, ARCA believes that Gencaro can become an important new therapy for many HF patients, with the potential for positive clinical outcomes in a defined genetic subpopulation, and good tolerability. Gencaro was the subject of a major North America based heart failure Phase III trial, known as BEST, which ARCA believes will provide the primary basis for the FDA’s determination on the approvability of Gencaro in the U.S. In September 2008, the FDA formally accepted for filing ARCA’s New Drug Application, or NDA, for Gencaro as a potential treatment for HF. In accordance with the Prescription Drug User Fee Act, or PDUFA, the FDA’s goal is to complete its review of the Gencaro NDA by May 31, 2009.

As previously noted in ARCA’S Annual Report on Form 10-K, the regulatory approval process for the Gencaro NDA is expensive and time-consuming and subject to the risk that the FDA may determine that the available clinical data for Gencaro are not sufficiently strong to demonstrate Gencaro’s safety and efficacy. Any such determination could prevent or delay regulatory approval and commercialization of Gencaro. As part of the FDA review of the NDA, ARCA has had extensive interactions with, and has recently provided substantial supplemental information to the FDA. The submission of this or additional information could result in an extension of the review of the Gencaro NDA beyond the May 31, 2009 PDUFA date.