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fred198484

07/27/17 3:44 PM

#28896 RE: Samsa #28894

I wish I could give you a definitive answer on how long those tests might take. My guess is the category 2 tests take a long time but the category 3 tests can be accomplished much faster and at low cost. That just makes sense - it should not take too long to find people to use as guinea pigs to test the abuse deterrent properties of Rexista. And therefore it should not cost a lot of money. Which makes you wonder why they just did not do those tests already. I suspect the tenor of the meeting would have been completely different if those tests had been completed. They could have explained away the lack of category 2 tests due to bioequivalence and if they had category 3 tests in hand, that might have been easier for the committee to swallow.