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Replies to #51486 on Biotech Values
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walldiver

08/24/07 10:13 PM

#51499 RE: stuck_holder #51486

I'm in favor of the lawsuit because it shines light on the issue. I would like to see Hussain and Scher testify to who asked them to write their letters to the FDA, and if those letters were actually written by the two good doctors. I'd also like to see how far financially Scher is tied into Proquest Investments. Then, I'd like to see exactly what role CDER/OOD had behind the scenes. Finally, I'd like to see what the CBER officials who made the decision have to say. I don't know if any of the latter will have to answer questions.

The lawsuit might also accomplish the task of keeping enough pressure on the FDA that it is forced to approve Provenge if the BLA is refiled after the interim 9902B results are released. Without this pressure, I could easily foresee Pazdur, Hussain, and Scher again fighting tooth and nail to keep it off the market, even with stat sig interim results.