What I gather from this infographic is if our NDA is filed, it is basically game over. It becomes more of a 'review' and how to present the drug to consumers with the proper labelling for side effects (Seroquel comes to mind, where it was causing sudden cardiac deaths and the FDA still approved it but placed a warning label on the packet).
The main and most 'severe' side effect from our study was diarrhea, which can be easily mitigated through the use of other healthcare strategies. We had 'clinically significant results' which is massive in the language of science. They do not use the term 'clinically significant' lightly.
My opinion is this is the end. If the NDA is accepted we are 99.9999999% derisked. Always the possibility of something strange happening, in which case ACADIA will just rectify the issue and apply again anyway.
Good luck boys and gals. We may be filthy rich in less than two weeks.
What I gather from this infographic is if our NDA is filed, it...
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