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Re: ExtremelyBullishZig post# 464717

Wednesday, 07/24/2024 11:48:23 AM

Wednesday, July 24, 2024 11:48:23 AM

Post# of 468759
Thats speculation.
FDA does not encourage (in fact, strongly discourages) NDA filing until they see some semblance of a chance.
EMA should be similar. They certainly saw AVXL data --- whether they "encouraged" or merely said "the approval depends on careful review (i.e., data doesn't look insufficient/terrible, so its a matter of review)" ... we'll never know.
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