News Focus
News Focus
icon url

crescentmotor

08/11/24 9:18 PM

#467190 RE: Steady_T #467178

The results do not have to the best thing since sliced bread,



Given the new data that shows a higher level of dropouts than many expected due to drug titration issues , how much of a problem might that be in the context of the original small number of 509 patients and a smaller number of completers? We now finally have the answer as to why Missling did not furnish the separate mild and moderate cohort data more than one and one-half years ago. I can't help but wonder if Missling approached the FDA long ago with the Phase 2b/III results. It seems highly unlikely to me that there would not have been any interaction with respect to a "successful" potentially pivotal late stage Alzheimer's trial. And I wonder if or when the European authorities were informed about the titration issue, which is very much linked to dosage level and thus efficacy? The bottom line is that AVXL's Phase 2b/III data has been and remains murky with lingering questions. I don't exactly have a warm and fuzzy feeling any more about the MAA application. Has Missling given us the whole complete picture regarding the potential MAA application given his history of withholding information? I guess in a couple of months the reality will become more in focus.