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Biotech / Medical : Biotech & Pharma.T.A, -- Ignore unavailable to you. Want to Upgrade?

To: Jibacoa who wrote (2789)	5/17/2010 12:02:52 PM
From: Jibacoa	Read Replies (1) \| Respond to of 3722

ABIO was up 33.02% and is still up 19.44% at present with volume of > 2.795M already >its ADV. The stock opened with a good size UG. bigcharts.marketwatch.com ABIO announced announced today that it has reached agreement with the FDA regarding an SPA on the design of a clinical trial to assess the safety and efficacy of bucindolol in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to bucindolol. Bucindolol is ABIO's beta-blocker and mild vasodilator. In November 2009 the FDA granted Fast Track designation to bucindolol for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. In March 2010, ABIO was awarded a patent on methods of treating heart failure patients with bucindolol based on genetic testing. Bucindolol is unique among beta-blockers in having been shown to lower systemic norepinephrine levels and facilitate conversion of constitutively active beta-1 Arg receptors to an inactive state,which may explain its more favorable response in the beta-1 389 Arg/Arg genotype versus the response in another common genotype of the beta-1 receptor known as 389 Gly. The primary endpoint of the planned trial is a composite of cardiovascular mortality and cardiovascular hospitalization. The trial protocol includes two interim data analyses at pre-specified numbers of primary endpoints. If the results of either of the interim analyses meet the pre-specified criteria, ABIO would be able to formally submit a complete response to the FDA’s May 2009 Complete Response Letter and the results of the interim analysis could serve as the clinical effectiveness basis for FDA approval. The planned trial is estimated that will take 3.5 years. ABIO's goal is to have bucindolol commercially available soon after the conclusion of the trial. The nearest resistance is at $6 and then the H at the spike on March 26 at $9.23 <g> bigcharts.marketwatch.com ABIO has no significant LTD but has been burning its cash at a fast clip and has a large negative CF.<g> It was able to cut its losses significantly last Yr. from $27.72 to $3.72/shr. And although the 4thQ included a $6M charge for in-process research and development,it will need some kind of cash infusion in order to proceed with its plans.<g> The ACTAY is $0.50 The short ratio came down 20% in the last month. Although the stock traded at $986 in Jan2001 it seems better to wait for further news and to see if the stock can get again above the $6 level.<g> bigcharts.marketwatch.com Bernard