Replies to post #166532 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

Biostockclub, thanks for the valued feedback. Shewart (sp)the famous statistician said: " Data is worthless without context". BTW, he is the guy who did all the work for which Dr.Deming gets a lot of credit. They were both brilliant. But the point is made on process and context, which in this case may be the same thing. In this case Precision Medicine both enables and requires a technical-scientific skill set which may be already available today waiting to be properly directed by many private companies and academia. IMO, either private industry profit motivations or government funding must be added.

Sadly, the FDA are the last people on the planet to be asked to lead such a P.M. initiative, but, there it is. If we needed a bunch of rules written, then the FDA would be the place to go but we do not yet have the rules properly outlined. The Aus. A2-73 trials results will be the first example of what P.M. is capable of. P.M. rules must be politically sterile. The P.M. examples for verification and validation might be unique CNS disease indications. IMO, instead of proving that the Amyloid Thesis is valid the P.M. technical goal is to prove that CNS cellular homeostasis (restore and regen) is viable as a practice in medicine.

[Jonjones325]

What do we expect to see at CTAD?

To have our data be confirmatory. I would like to see:
-the only patients that dropped out did not fit our profile or could not continue due to health
-the 19 left all fit our profile and all have Some type of benefit regardless which dosage they’re on. It’d be nice if they provide some RWE for them
-long term safety continues
-side by side comparison to the SOC

The above would be confirmatory and would be a home run. However, I believe this would be a dream scenario and would be unlikely.

If we only get data on the 5 or 6 strong responders. With a few outliers and no data on the rest of the 19. And nothing about the dropouts. Then we will get laughed at and maybe deservedly. It will lead to more questions and doubt. And more bashers. “I told you” moments.

If we are fighting a war. If we want to get a clear message out. If this is really our time? Then we must bring it. If we have it.

Will it be another ho hum or the final nail in the coffin for the amyloid hypothesis?