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misiu143

07/21/17 1:41 PM

#16145 RE: fred198484 #16144

FDA did change class of resistant for Pro 140.

As per protocol it is " within two or more drug classes "

BlackDoggie

07/21/17 1:43 PM

#16146 RE: fred198484 #16144

Glad I'm not missing anything obvious. Perhaps the FDA felt that with the concession of bringing the n down to 30, they needed the higher bar as a balance? Not sure we'll ever get the answer to that one. Hopefully the company has had these discussions and may, at some point soon, be in a position to openly discuss the labeling they'll be pushing for.