Thanks Mongoose for your comprehensive and common sense response. I agree with every word you wrote and would add some emphasis to a few points you bring up.
1. I do agree we are caught in some kind of parallel universe comm. zone time warp made up of FDA and Govt/politics and the enormous need for REAL HONEST MEDICAL SCIENCE. Three years ago before I ever heard of A2-73 I would have defended the FDA and the BP systems established for clinical trials and scientific methods in play. Over time w/study I have begun to seriously question how the process is working and in fact am now convinced the process is seriously flawed, perhaps even criminal in areas. Having spent time as a lab rat and much time around regulatory practice/financial reality I now see the failures around AD and other CNS diseases as poorly executed, expensive, political, frauds on taxpayers and sick people. A child could ask some basic questions in retrospective analysis and conclude they should have stopped what they were doing 10-20 years ago. The good news is that entire level of thinking and statistical modeling is gone or is going away (they will just not admit it yet). We need medical/scientific facts, not statisticians and smoke. Trials will now be managed w/science and thankfully using RWE, which must be easily and credibly explained and proven.
2. AVXL is a very small company and would easily be destroyed by just one error in judgement. Timing, scientific events, PR's, political , financial, mistaken sequence...and the list goes on. The problem we have in dealing w/this environment is we have very little ammo and there are lots of targets. Dr. M. must find a communication tactic that works for him and that is effective, being silent is not a communication strategy, even though he is good at it. IMO, eventually silence becomes a bad habit and eventually it adversely impacts credibility.
3. Dr. M. must capture and present the context we are in more effectively. He can do this w/o betting the farm by being open about our A2-73 testing strategies and methods. And he must do that right away while all the competition are still down in their bunkers. The FDA and BP are clearly scared shatless about making a wrong move right now on ANYTHING . Musashi was a great warrior his famous poem on the .."The Pen and the Sword , in ACCORD" , has never been more meaningful than right now in this space. It is time to ACT with superior tactics which IMO will require generous use of RWE and precision medical science. One strong case made w/the FDA will save them from continued humiliation and will rewrite the future on CNS medical science. IMO, AVXL is capable of showing the way.
IMO, the window will close if he does not act soon.
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