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Re: FeMike post# 595926

Thursday, 05/25/2023 12:00:20 PM

Thursday, May 25, 2023 12:00:20 PM

Post# of 702443
Based upon known facts it's highly probable that management are engaged in rolling review with the FDA and MHRA. From the 2022 ASM we learned that the application was in process for the entirety of that year. It makes little sense the documents would sit on a shelf when they can be submitted in a modular fashion.

The SEC would not require this be disclosed, as it's not material until the regulators sign off on approval or issue a denial, whereas regulatory approval processes are private meaning drug regulators themsleves do not disclose any applications.

The firm remains in a quiet period while nothing has leaked partially because of this wise decision to not be verbose at this crucial time. RegFD violation, more erroneous lawsuits or complaints, would be very bad hence why management engage in the best practice of remaining quiet until approval.

No evidence exists contrary to my claims on this matter.
Bullish
Bullish

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