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boi568

02/29/24 1:24 PM

#452964 RE: Bourbon_on_my_cornflakes #452962

I've taken a good look at the EMA pre submission process and how it corresponds to what we have heard from Anavex. Pre submission takes a set number of months, and they don't shortcut that time frame. Missling cannot make this stage any faster.

The rough analogy I use is comparing it to airport scheduling. The airport has only so much capacity to service planes and passengers, so to control workflow they must provide specific slots and schedules for the planes.

Post submission, the EMA seems to have more flexibility, although it's limited.
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Anshu2

03/01/24 11:29 AM

#453084 RE: Bourbon_on_my_cornflakes #452962

FIRST Q is whether the EMA submission will indeed happen. I'm not very confident. My personal probability of an EMA submission happening (ever) is 50%. If it doesn't happen --- I can't imagine it happening anytime before 3-4Q 24. My pessimism is well founded.