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flipper44

08/27/22 6:34 PM

#508595 RE: pqr #508594

Not all material info is obligated to be promptly published, under all circumstances. Maybe the difference between a company submitting an MAA and a regulatory agency accepting their MAA is also a line between material versus material obligation. Anyway, I found this article helpful.

https://westwicke.com/2019/11/keys-to-successful-disclosure-of-clinical-trial-data-and-milestones/
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dennisdave

08/27/22 6:55 PM

#508596 RE: pqr #508594

I can assure you the filing of the MAA is not a material event
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biosectinvestor

08/27/22 7:00 PM

#508598 RE: pqr #508594

You are correct. It is not a material event. Neither is acceptance of their initial application or rejection of their initial application (not on substance but to start the process) which just means they need to add information or complete something. If their application is rejected with finality, that of course is an explicit material event that is covered in the 8-K instructions.

Voluntary disclosures can be about most anything they want to disclose, but they have the option to disclose. Whether they think it is useful or not, is up to them and despite shareholders wanting to know, that is probably not the dispositive factor in making their determination.