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frrol

02/07/24 3:43 PM

#451215 RE: Doc328 #451185

The company is doing what it can with the results we've got, though it's amazing that almost 2 years after the AD trial has ended they have still not met with the FDA. It does sound like the AD paper draft was complete and is being reviewed. Missling said the Excellence Rett trial is no longer considered pivotal, though he's hoping to be surprised when they meet with the FDA. As the investors here have been saying, we likely have a Rett full phase 3 in our future.

The call also made clear that Missling's line continues to be that, for AD, our MOA, safety profile and oral dosage should have some positive influence with regulators.