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Re: Dan88 post# 601063

Tuesday, 06/13/2023 12:42:58 PM

Tuesday, June 13, 2023 12:42:58 PM

Post# of 711192
I agree Dan. In the eyes of the SEC any company in discussions with regulators on drug approval must be accurate in their representations of what regulators communicate especially with regards to negative feedback.

We have not received any from the company so I believe we are in a good position. The issued MIA and approved PIP provide context as do the accepted amended Statistical Analysis Plan. There's been many opportunities for regulators to say "no" while it would be unambiguous fraud for management to withhold any negative feedback such as CRL requiring new trial. I don't think the coauthor of NAFA and EU Patent Law, a person on impeccable character, would engage in such criminal behavior as that only harms herself financially as a large shareholder.

I personally still believe we are engaged in rolling review, as management want this across the finish line as soon as possible, so it would not be wise for the company to begin speaking publicly until that process has concluded especially given the ongoing manipulation.

Crucially would insiders engage in estate planning for this tax year if they thought approval wasn't happening in 2023? No, in my opinion, they would wait until the price falls further then do it later in the future.
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