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News Focus
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Venture_Cap

08/04/20 11:48 AM

#101969 RE: hopester #101962

Actually it does, that’s why the operation Warp Speed was created. But it’s done their way under their protocols.

The FDA is pushing drug companies to expedite clinical trials in a professional manner and also allowing DSMB reviews mid way that would normally not be allowed. Pandemics typically push status quo.

FDA is responding to pressure no doubt.
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fsoalex

08/04/20 12:35 PM

#101994 RE: hopester #101962

I would add that the FDA will wait on the write up by AM a wreck. They don’t approve based on press releases or message boards. As we saw with the BLA submit, FDA analyzed the write up and wanted more info. Before everyone hyperventilates that it was rigged, remember we pay Amarek to know what needs to be provided. They missed. Let’s hope they learned and do better with the COVID write up.
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The oNiOnHEAd

08/04/20 2:46 PM

#102055 RE: hopester #101962

Yeah, and the FDA didn't pull Fen Phen because of public outcry. Someone's children dying because the FDA won't approve a drug that is known to safe lives is reason enough to say and do nothing.