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dr_lowenstein

03/03/17 6:51 PM

#245092 RE: lasers #245091

Those of us in the Pharma Industry know that is bs. A modified

dr_lowenstein

03/03/17 6:57 PM

#245093 RE: lasers #245091

Those of us in the pharma industry know that is bs. A modification is a reformulation. Just ask the FDA.

lasers

03/03/17 7:10 PM

#245094 RE: lasers #245091

Exactly why the FDA has ruled that a new Phase3 trial is NOT required!!!!

jour_trader

03/03/17 7:26 PM

#245097 RE: lasers #245091

Yes, that is a reformulation, re-engineering, adjustment, modification, to fix the Tmax issue that the original could not muster.