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Post# of 463997
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Re: hnbadger1 post# 440081

Saturday, 11/25/2023 12:05:25 PM

Saturday, November 25, 2023 12:05:25 PM

Post# of 463997
We don't know exactly what data was presented to the EMA. Apparently enough data was presented such that the EMA thought it was worth filing an NDA and looking at the full NDA package.

The meetings and initial date presentation is the start of the approval process. The submission of the full NDA package can be 7 months in the future.

The real folly is ignoring the progress the company has made.

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