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67stang

02/07/14 9:46 PM

#25163 RE: johnking29 #25162

They should cut amrn a little slack, and any other co's that had a SPA
in place when the ball was in the air..
esp when it is so safe..they are supposed to weigh benefits/risk...

clearly the risk here is to not approve with what is known about
elevated trigs and the safety/ efficacy profile of V.

I see a label compromise..and consider this time out as time served.


ggwpq

02/07/14 10:09 PM

#25165 RE: johnking29 #25162

John, can you name other companies that are now facing the same new "Prove It" mentality of the FDA? TIA.