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Sunday, 02/03/2019 1:33:01 PM

Sunday, February 03, 2019 1:33:01 PM

Post# of 17421
AUPH threw a Hail Mary for the Ph 2 DES trial, when it was not needed. That worries me, for Dr. Glickman has been spot on up until now.

I mentioned the situation (as best I could) to a friend who does contract work for various drug companies undertaking clinical trials. He said it was simple – the primary endpoint should have been to prove non-inferiority in tolerability relative to Restasis. After all, Restasis was already deemed by the FDA as an approved treatment for DES. Any result better than that would have provided a resounding victory when coupled with the efficacy findings. Furthermore, it would have kept naysayers, such as Adam Feuerstein and company, from characterizing the findings as “mixed results” or as a “flop”.
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