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Re: doogdilinger post# 11637

Monday, 06/22/2015 9:02:31 PM

Monday, June 22, 2015 9:02:31 PM

Post# of 38634
doogdilinger, I'll take that as a ---No---

They had to re-do their phase I trials with PODRAS incorporated into Rexista k WeeZuhl...and that's what precipitated the FDA's 2 recent decisions...

1st to grant them designation for fast track status...then to immediately follow that fast track decision up by advising them that they were so impressed with phase I that they could skip phase III trials entirely and simply submit bioequivalence prior to officially submitting their Rexista NDA k cheers!




No, you can not describe PODRAS or how it works, and No, you cannot prove that Rexista with PODRAS has passed bioequivalence.

"There are three kinds of lies: lies, damned lies, and statistics."