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JamesGMS

04/07/16 9:43 PM

#261134 RE: exwannabe #261129

Exwannabe, Well then you may get your wish quite soon - I'm told Dr. Garnick's mood has greatly improved these past few days. I wonder what's up?

Quote: Can one initiate a FOIA to get it?


No.

Even if the FDA has the data, it is confidential until the drug is approved.



James
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thealias2002

04/07/16 10:50 PM

#261142 RE: exwannabe #261129

Two questions...

1. Given the MOA of Bavi, why would the first look-in be scheduled at it was? Why not wait to make sure separation had occurred/reduce risk that it hadn't occurred?

2. Is there any reason in the world that Garnick may have wanted the trial to unblind early??