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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (31359)	5/30/2009 11:36:05 PM
From: Dave O.	Respond to of 52153

< the panel votes narrowly in favor of the drug. In that case the FDA could ultimately decide to require more data > They had a SPA with the FDA which may help them. Also, with the OLE (Open Label Extension) they now have some patients from the trial who have used the drug 2 years. The following is from an 8K they filed: "The slide in the plenary session depicting cardiovascular SAEs was intended to positively demonstrate that the five patients with an opportunity for re-challenge continued in and completed the Phase 3 studies without interruption of pegloticase treatment. And furthermore, all five enrolled in the open-label extension and continued drug therapy. None of these patients had a subsequent cardiac event, although one did discontinue in the open-label extension due to an infusion reaction. The successful re-challenge of a patient after an adverse event is generally viewed as a high level of evidence that there is no causal link between a drug and an adverse event, particularly when the re-challenge period extends over months without a recurrence of the adverse event, as was the case for these five patients." Sounds positive but who knows how the panel will view it. And a lot may depend on how well the company presents to the panel.