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Re: crescentmotor post# 452737

Monday, 02/26/2024 12:49:22 AM

Monday, February 26, 2024 12:49:22 AM

Post# of 458401
From what I've read there are a few things that could turn things around rapidly, but I have no idea when they'll occur, but I believe they will occur. One is the publication of a peer reviewed article in a Journal, but I have no idea which one. My prior experience is that Journal's take much longer than most investors think. The others have to do with filing for approval, the timing for that is purely up to the company, but once again it often takes longer to do than most investors think, and sometimes much longer than companies think they can do them.

As to feedback from the FDA or other regulators, most companies say nothing unless it's something they must say. If in discussions with the FDA they're told that additional trials are required for RETT's, they'd announce new trials. If on the other hand they were encouraged to file an NDA, I doubt if they'd say the FDA advised doing so, they might say they're doing it, or wait and announce they'd filed. The fact that they've announced the intent to file an MAA would seem to indicate that they'd announce another if it's planned, if it is, it's very probably coming after successful discussions with one or more of the regulators.

Gary
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