Replies to post #364579 on Anavex Life Sciences Corp (AVXL)

[rayovacAAA]

LINK TO "THE FDA'S 6 TO 3 VOTE AGAINST ACAD'S DRUG TO TREAT RETT???????

Yes. Based on the FDA's 6 to 3 vote against ACAD's drug to treat Rett,

[rayovacAAA]

MISINFORMATION!!!!!!!!: Based on the FDA's 6 to 3 vote against ACAD's drug to treat Rett

Yes. Based on the FDA's 6 to 3 vote against ACAD's drug to treat Rett,

THE FDA DID NOTHING OF THE SORT!!!!!!!!

[Doc328]

The FDA ACAD vote had nothing to do with Rett.

ACAD was trying to expand the label for Nuplazid (pimavanserin). Currently, it is FDA indicated for hallucinations/delusions for Parkinson Disease (fairly common late in the disease with PDD). ACAD wanted to expand for the same issues in Alzheimer's Disease. Data was not great and the advisory board voted against this indication. ACAD's briefing doc's for the recent advisory board

ACAD has not yet submitted an NDA for Rett but released their topline data in December, 2021 (Lavender study). An NDA usually takes 6-10 months to prepare so they will likely submit in the next few months. They have BTD,ODD, RPD similar to Anavex for A273 in Rett. Therefore, I expect Q3 NDA with PDUFA date 2023Q1 (6 months after NDA submission). Expect an advisory board for trofinetide about 6 weeks before the PDUFA date.
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