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Re: gerry57 post# 458804

Saturday, 05/11/2024 9:35:19 AM

Saturday, May 11, 2024 9:35:19 AM

Post# of 469969
Your "literal" interpretation was silly, of course. If the company executes well, we will be able to submit the MAA late summer / early fall. It was nice to see that Missling is aware of the need to consult with the EMA during the 7+ month preparation phase to avoid delayed submission acceptance. I'm confident the company has third party assistance in the MAA, as we have ample cash to pay for it. As for manufacturing, the MAA includes information on the manufacturing process and planned site(s), but does not require contracts, and drug companies rarely announce them. So the wisest course in your case is to just wait for MAA submission.

Our Rett program had a setback, but AD has a plausible (albeit uncertain) path to approval, thanks to a drop/rationalization in regulatory standards, both in the US and Europe.
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