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Re: mrplmer post# 444885

Monday, 01/01/2024 2:12:34 AM

Monday, January 01, 2024 2:12:34 AM

Post# of 462172
Getting an approval to file an MAA as a centralized marketing application is not a material event.
The company chose to PR that approval. It was not required to do so.

Edit, reply to later posts.

An agency decision on an NDA or MAA is a material event because it has significant financial impact on the company which ever way the decision goes.

If the decision is no approval that means the write off of all the development costs. If it is an approval it means likely significant revenues in the near future.

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