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crescentmotor

02/11/24 2:38 AM

#451633 RE: Steady_T #451631

At this point AD is at the NDA preparation process stage, not running trials stage so the cost is manageable.



My issue with that is we have no idea what the FDA position is going to be regarding AD. The FDA could require an additional large Phase III trial. If so, there goes your "manageable" cost theory. Further, we actually don't know what is about to happen with AD in Europe. Like I posted, no harm in "chit-chat" with the FDA regarding Rett to get a clearer picture of the path forward. I am certain the right answer for AVXL, at this time, is not to find itself running new multi-year trials in AD, Rett, and Schizophrenia without taking on a partner. The overall picture will be much clearer in a few months--no time to act in haste.

ExtremelyBullishZig

02/11/24 10:06 AM

#451642 RE: Steady_T #451631

A trial failure is a trial failure