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Re: biomaven0 post# 152480

Thursday, 11/15/2012 11:03:59 PM

Thursday, November 15, 2012 11:03:59 PM

Post# of 252686
Peter

I listened to the panel today. there was a definite 13-1 (93%) enthusiastic vote on the efficacy.

An 8 (57%)/ 5(36%) / 1(7%) on the safety aspect. not because the safety aspects had poor results (they were actually good) but b/c they wanted a larger population.

What are your thoughts of this effect on the share price. it seems way to harsh.

Also i would imagine, as you said, fda approval after this vote seems unlikely that they would move against the panel. Those in favor of the safety were ok with post production increased population testing. Would the fda supersede something like this and allow post approval increased population testing. Does this happen often?

Assuming in February fda approval is postponed for the same reason how long would an increased testing population likely push the timeline?

Just checking for your thoughts.



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