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Re: A deleted message

Sunday, 01/26/2020 10:36:52 PM

Sunday, January 26, 2020 10:36:52 PM

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JJ. . . I agree with your post 100%. It's maddening that the FDA had Elite spend all that money on SequestOx trials only to have them issue a CRL in the end. Elite followed the FDA's guidance to the letter and then, in the end, changed their mind. And of course Nasrat was blamed the FDA's fickle mindedness. Anyway, this is old news. Elite is now on the cusp of a history making event that will change Elite's financial landscape in a major positive way. GLTU

It isn't even about Tmax. That was just a convenient excuse for the FDA.
Tmax was never the problem as they would have liked people to believe it was. Total BS and the FDA knew it. The AdComm in many cases is a joke.

Am sure if Elite was a much larger pharma with deep pockets they could have gotten a pass. Wink wink....

Pay for play. Especially with this administration.

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