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Tuesday, 11/18/2025 11:49:45 AM

Tuesday, November 18, 2025 11:49:45 AM

Post# of 516061
Trying to understand “negative trend”

The Company was informed by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of a negative trend vote on the Marketing Authorisation Application (MAA) for blarcamesine following its CHMP oral explanation.

The first explanation that comes to mind is that formal voting had begun and a majority of those votes were for disapproval. There might still be time to turn these members around.

A second possibility is that some (or maybe most) voters were withholding their votes until they received more information regarding ADL or some other matter covered in the oral presentation. This might allow for more info to be submitted (if allowed) to the members before the final vote.

A third (and less desirable possibility) is that after all the smoke clears, my family may be eating bologna sandwiches for Thanksgiving and Christmas.
Hope that’s not the case.

Bill
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