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honestabe13

12/31/13 10:19 AM

#172003 RE: biomaven0 #172002

yet people here assume the know the FDA was critical...
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Robert C Jonson

12/31/13 10:20 AM

#172004 RE: biomaven0 #172002


If the drug has reasonable toxicity, the FDA will let you proceed with a Phase III. So "achieving a Phase III approval" really doesn't mean much.

So, Peter, are you saying that if a drug is safe, it doesn't have to have any indication of efficacy in order to get the go-ahead for a phIII trial from the FDA?

Bob