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Biotech / Medical : Acorda Therapeutics Inc. -- Ignore unavailable to you. Want to Upgrade?


To: Arthur Radley who wrote (66)10/9/2009 2:44:56 PM
From: idos1 Recommendation  Respond to of 120
 
Yes, exactly my thoughts. I hope that if there's a majority of MS specialists on the panel, they won't debate too much and recommend for approval.



To: Arthur Radley who wrote (66)10/9/2009 2:48:09 PM
From: tuck1 Recommendation  Read Replies (1) | Respond to of 120
 
Maybe this explains the unusual language you pointed to on the valuation thread. The FDA as a whole might be bound by the SPA, but the individual reviewers/statisticians contributing to the briefing docs can look at all the data they want as prelude to a panel meeting. Right? Might be a buying op, because as Idos points out it's the responder analysis that hit stat sig and is the primary endpoint per the SPA. Although the FDA could easily come up with another excuse based on safety. But then we're back to the SR versus compounding question.

At this point, I think approval is not priced in, but unless the FDA ignores the SPA, it seems as though it should be approved, with REMS and black box, of course. Hence a possible buying op. A small flyer with calls being the safest way, I'd think.

Cheers, Tuck