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Re: dr_lowenstein post# 31893

Wednesday, 07/29/2015 2:25:22 PM

Wednesday, July 29, 2015 2:25:22 PM

Post# of 48316
The American legal system is a precedent based system. The FDA system is not a precedent based system. End users use previous FDA decisions to help predict what they may do in the future. The FDA acts based on criteria and merit and not precedent. It may not seem that way all the time, but there is a subtle and substantial difference.

Concerning precedent for approval based on P2B results - I'll leave that for you to research since any data or example I might give you would be summarily dismissed for a myriad of reasons for which I do not care to argue about. It is better if you find the examples and draw your own conclusions instead of relying on what I might provide.