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Re: XenaLives post# 140176

Wednesday, 02/07/2018 11:42:37 AM

Wednesday, February 07, 2018 11:42:37 AM

Post# of 461425

I like the ring of that.

Me to.

The picture is clearing up a little on how we got here. I do not agree w/those who say it is just poorly managed or by default somehow. The links with and impacts (if any) of the precision medicine trials protocol and AVXL timeline decisions are still not understood. M. said early on that P3 is just confirmation of what (should be) already known.

Did precision medicine simply present an opportunity(which he now calls a strategic choice) for M. to rethink his data acquisition plans? I think we can see now that this coincidence has consequences in an expanded pretrial period. All future CNS trials will be done this way. Longer time in the barn before the trials start. That is a god thing but will completely change the way CNS work will be done going forward. A longer gestation period. Cannot say what it all means about how micro's tech's survive.

Whether he knew or not about the coincidence and timing is an open question for me. I can now see that once the FDA expressed their plans all existing time lines were meaningless if one chooses to follow that planned path. Did he know that? He should have said so up front. I do think the FDA/M. link on planning is getting pretty clear around here now. Hope he clarifies soon.
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