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Re: palindromy post# 44561

Sunday, 04/08/2007 2:59:27 AM

Sunday, April 08, 2007 2:59:27 AM

Post# of 257458
If they were to make approval conditional on successful data from 9902b, That's Subpart H/accelerated approval. The only way they could do that is approve based upon TTP but I think that's a stretch.

They can do a full approval conditional on the completion of 9902b, then worry about what to do with it if 9902b turns out negative. This is a fine line I know, but it is an important one.


Unless otherwise indicated, this is the personal viewpoint of David Miller and not necessarily that of Biotech Stock Research, LLC

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