Tuesday, May 01, 2018 9:49:53 AM
Cannot help but think the revolving door in FDA management is also a factor in apparent inability to get decisions and trial process support. They have been in the middle of significant process structural changes now for months. We have seen multiple BP's pull the plug on major initiatives they have had for years (AD) closing facilities and just seemingly walking away. WTF?. New trials protocol process rules are in flux or at least that is how it looks. AVXL has no sponsors in the room thx to the whole IPO-massive undetermined corruption links. We do not have to geniuses to figure out the consequences of chaos (must be playing out). Restructuring will be working the rounds of trials changes which will most likely reset the entire CNS drug approval process (IMO). No one spits in this country unless the FDA approves it and then relabels it, again and again following repeated AE reports(never mind). Evidence of past irresponsible decisions are everywhere.
My question is when is DR.G. going to do/say something definitive about the plan/schedule/rule set and roll out issues. Are we all supposed to sit around and act like everything is cool when it obviously is not. No wonder Dr.M. linked w/other countries he could but mark this post b/c until the FDA gets it's shat in one pile nothing of consequence will get done WW. like it or not the FDA is the gold standard and my frustration is running high.
Recent AVXL News
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- Anavex Life Sciences to Present at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 03/25/2024 11:30:00 AM
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