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boi568

12/19/23 8:59 AM

#443056 RE: frrol #443027

Today's PR is stunning.

The EMA flow chart contemplates a 7 month pre submission decisional process after a Letter of Intent. Ours took one month. The statistical odds of getting an MAA have just jumped to 95 to 96 percent (not to mention the accelerated time line we are enjoying).

The concordance stat between MAAs and NDAs is 84 to 85 percent, so the current stats on Anavex getting approved for AD in the EU and the US has moved to 80 percent.
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Steady_T

12/19/23 12:38 PM

#443181 RE: frrol #443027

As I understand the EMA procedure Anavex can't submit the MAA for 7 months after the letter.