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Msg  16887 of 16924  at  8/1/2020 11:46:06 AM  by


 In response to msg 16881 by  sphericalkutz
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Re: Has the feeling

Good morning Kutz,

Thank you very much for the thorough reply. I greatly appreciate your insight behind the green curtain, a perspective Im sure the vast majority of us here do not have.

On your comment about constant back and forth communication, that is where my Spidey senses tingle when Acadia brass said they too were surprised by the Standard designation. The FDA obviously understands this is a significant issue and I would think it would have been discussed with ACAD brass. Im really hoping that during the Q2 presentation Q&A we get more clarification.

On a separate note, am I in rare company in that I was hoping for an AdComm? Here is my rationale: First, strictly from a timeline perspective I like knowing a pre-set date of a very important material event rather than the state were in now with Standard Review and no scheduled AdComm, which means on any giving day, pre or post market, between now and April 3 we will get a PR with no warning. Second, I would absolutely appreciate hearing Dr. Cummings, Dr. Ballard, and other KOLs laying out the case for Pimavanserin with DRP. We are in a completely different situation now than we were during the 2016 NDA and AdComm since one of the biggest issues the FDA had was a lack of a proven safety record. Prior to the AdComm, Im certain many long time investors such as myself were surprised and anxious after reading the FDAs pre AdComm lengthy report which did not recommend approval based primary on safety issues and lack of data. We will, of course, never know what would have happened regarding Pimas approval or lack thereof had the experts not been able to provide the much needed discussion points brought up and addressed during the AdComm. I would greatly welcome an AdComm during this review as well.

Enjoy your weekend and thank you again for sharing your knowledge. I sincerely appreciate it!


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Msg # Subject Author Recs Date Posted
16888 Re: Has the feeling jim_pd 2 8/1/2020 1:30:25 PM
16891 Re: Has the feeling sphericalkutz 4 8/1/2020 8:39:16 PM

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