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Post by frangipan on Mar 31, 2014 15:59:50 GMT -5
Folks, I am a very long time long, and long time beneficiary of all of your thoughts and ideas for which I am very thankful. This is my first post. Still learning a lot so stay quiet.
I see that someone else mentioned this today already, but in my view it is important. It is a fact that an insider at FDA had a history of trading on decisions, so he obviously had had success with it, and he was caught trading MNKD right before our decision. I know the past is the past but shouldnt that give some information of FDA's inclination at least with respect to last go round?
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Post by alcc on Mar 31, 2014 16:16:04 GMT -5
If you read the narrative in the briefing doc recounting the history of the earlier 2 CRLs, imo those were not even close. But that may reflect nothing more than the opinions of the writers and reviewers of this latest document. No idea what the agency's position was at the time. Whatever it was, it doesn't matter now. We have to deal with this new set of characters.
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Post by nadathing on Mar 31, 2014 17:18:23 GMT -5
The assumption is there that Afrezza was going to be approved and it is supported by the insider trading. The truth is, we really don't know.
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