Am not at all caught up on the messages here today but wanted to share that I spoke with Anavex and here is what I heard:
- Rejection coming in December
- Appeal will be made (another 6 months until 2nd decision?)
- No idea what path forward is with FDA (said did not know what is happening there)
- Appeal will allow bringing in data that was not in the original filing
- None of the developments over the last year were considered by CHMP (no papers, no GWAS, etc.)
- I heard him say the company, especially experienced members, were confident approval is coming (FWIW)
- Nothing was said about any other P3 trial for any indication (which is disappointing to me)
Overall, a good call.
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