Replies to post #111639 on Anavex Life Sciences Corp (AVXL)

[Bourbon_on_my_cornflakes]

Agree, but dont think they are just sitting on their hands. They have been talking to the FDA all along about what they want to see in a trial to give accelerated approval, I would surmise. That is because there were already special procedures at the FDA to expedite any alz drug, which is a top national priority.

As I said a couple months back, Missling has made it very clear that you find out if the drug works in much cheaper P2, and P3 is the optimized trial to get the FDA signoff. For alz, the possibility of getting accelerated approval has been there all along, which is why we continued to keep extending the P2 trials so we would have an even better case for accelerated approval by showing long term safety and effectiveness.

So the new proposals by the Trump FDA are packaging, but the basic were there already for alz. That has been Misslings plan all along.

[nidan7500]

IMO, the breadcrumbs (from FDA and AVXL) lead to smaller trials with stronger evidence from P1/P2. Pre/clinical evidence used to assess certainty based on precision science with a deeper-precise understanding vs AD plaque assessment then backing into a rationale based on autopsies. IMO, A2-73 and Dr. M's assessment of why it works is the best game in town. Predictions for time to FDA release based on previous models are simply irrelevant, IMO. Put away the shotguns boys.

IMO, this FDA delay-time out period was inevitable (new lab capabilities/new S/W capabilities/old trials practice clearly unsuitable any longer & other). Then A2-73 comes along at exactly the right time providing an excellent example/opportunity to reset. There may be others also but nothing bigger than A2-73.