InvestorsHub Logo
icon url

Steady_T

01/01/24 3:07 PM

#444944 RE: Investor2014 #444943

Apparently you haven't read the timeline you linked. 7 months after submission of letter of intent before the MAA can be submitted.
Feb'ish is not an option.
icon url

BakedLangostino

01/01/24 5:56 PM

#444956 RE: Investor2014 #444943

Alzheimer's EMA submission will probably occur sometime between April and July.

Rett FDA submission will probably be sometime in Q3 2024.

Alzheimer's FDA submission will probably be in early 2025, assuming the FDA considers the data from the extension trial that is set to wrap up this summer acceptable for a confirmatory trial. If the FDA requests a proper P3 trial, the NDA could be punted until 2026 -- but at this point we'll know whether Blarcamesine works and the share price should reflect the revenues from Rett and the European Alzheimer's market.
icon url

ExtremelyBullishZig

01/01/24 6:02 PM

#444957 RE: Investor2014 #444943

They only think an MAA isn't material if they don't hear anything for awhile. That way it fits their narrative. See how that works?...LOL