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Message: Re: I gotta say

Aug 21, 2012 09:06PM

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Aug 30, 2012 01:32AM

Aug 30, 2012 01:44AM

I'm very well aware of Martin Shkreli actions on mnkd as well as FDA insider trading etc. Yes, he did send a detailed memo to FDA prior to approval. But if you think FDA did a complete turn-around purely based on his letter, you are falling prey to stupid conspiracy theories espoused by random blog writers. Lol, FDA is not a random body who gets swayed by shorties out there...and there is absolutely no inkling of proof that it would have accepted Afrezza otherwise.

A single CRL is like a life or death for many biotechs out there...ends up costing 10's if not 100's of millions until the next resubmission. I don't think AlMann would have meekly accepted a weak answer from FDA. Please do not base your approval theory on this alone. Yes, there are merits to this drug and the trials 171 and 177 are proof itself on the drug labeling and direction.

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Aug 30, 2012 03:06AM

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Aug 30, 2012 03:54AM
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