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Message: Re: Short interest uptick
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Nov 06, 2019 10:58AM
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Nov 06, 2019 11:03AM
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Nov 06, 2019 11:24AM
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Nov 07, 2019 09:14AM
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Nov 07, 2019 09:31AM
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Nov 07, 2019 10:24AM
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Nov 07, 2019 10:51AM
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Nov 07, 2019 08:33PM
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Nov 07, 2019 10:46PM

Re your second para oldtimer, I think it’s unlikely the FDA meets with all companies post-trial. After all, what would be the point if, as often is the case, a trial is unequivocally negative? In the absence of any safety issue, I would imagine a post-trial meeting is held only when:

1. The endpoint results have raised the possibility of marketing approval for one or more conditions; 

or

2. The results for an important endpoint just missed statistical significance and the company wants to reach agreement with the FDA on the way forward.

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Nov 08, 2019 03:33PM
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