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biosectinvestor

05/26/24 2:00 PM

#694147 RE: exwannabe #694146

I have it on good authority. I’m not here to justify it to you. I agreed with Flipper. If you don’t like it, that’s your problem.

The event happens once, when it is communicated initially. Follow-on notification is a formality. The clock starts at the earlier date of actual determination.

Two very reliable sources have said, at various times, because there was no change to the initial application, it was either 1) the actually application date in December, or 2) the actual date the application is first considered valid for review and that is considered the date the decision was made, which is known as "the Validation Date". For the EMA, that is the January date, which is literally the date when the application passed validation. Confirmation is NOT in any context a relevant date, it is just a communication deadline.

I did not say the company has not received any request for information since or the clock has not stopped since. I HAVE NO IDEA.

I am going on that particular bit of information though and that seems quite certain and determinate. I have virtually zero doubt on that determination. Though regulators are always strange and fickle and you often can't rely on them entirely to not do the most inconvenient thing possible, just because.

The company has done absolutely nothing to miscommunicate. That's nonsense. In fact they say:

As is typical, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company will announce the results when the regulatory review and decision - making about the MAA is complete."

Bullish
Bullish