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CommonCents3

12/23/24 5:10 PM

#477582 RE: Investor2014 #477581

This is why they made the expert hires that they made. Missling has known he has the real deal for some time, but he needed experts in trial design and regulatory navigation. Good leaders surround themselves with people smarter than themselves. Missling has done exactly that. Kudos to him
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Doc328

12/23/24 5:25 PM

#477584 RE: Investor2014 #477581

it is good news in the sense that the P2a and P2b/3 peer reviews are not full of disparities of conclusions for EMA to pick holes in.



Like one study showing benefit in activities of daily living but not cognition and the other showing benefit in cognition but not ADL's? They were consistent in percent dropouts due to tolerability.

In all fairness, today's news is good and in deference to Bayes, I have adjusted the likelihood of approval without a larger longer phase 3 to from 1-2% to 3-4%. This will take a large jump up if the MAA makes it to the other side of the first clock stop after the EMA has a chance to run some of its own analysis with the data.