Replies to post #142041 on Anavex Life Sciences Corp (AVXL)

[bennyboy1]

Several days ago, Clint at Anavex confirmed to me we are just waiting on the FDA for a go-ahead on Rett. He also stated Anavex revised their design and changes were made and sent on to the FDA. As of right now, we assume they are awaiting a go from the FDA for Rett Syndrome!

[XenaLives]

Because the guidelines are new, I suspect that there is a lot of back and forth because no company is better qualified than Anavex to discuss these issues and help the FDA work out solutions. I suspect the relationship is symbiotic, not adversarial.

The FDA knows that Anavex 2-73 is their best bet for treating Alzheimer's and probably a host of other CNS diseases but government is not always as efficient as it should be.

[BIOChecker4]

By my calculation, AVXL filed their Rett IND in late October or early November. Sometime within the 30-day window following the filing, I believe the FDA placed a clinical hold on the trial. I believe they must have had questions that AVXL then had to address, possibly because they'd be treating children, whose physiology is different than the physiology of adults. The language of the December 11 PR suggests to me that AVXL had provided a response and was awaiting further feedback from the FDA as of that date. The fact that the trial has still not begun 2+ months later suggests to me that the FDA still has concerns, so I think either AVXL is in the process of providing additional information or they've done so and are back in wait mode. My guess is they're still putting additional information together (possibly genomic data at FDA's request). All of the guessing by posters, myself included, is pure speculation, since the company has not been forthright about the situation. I would remind everyone that for at least a year, TGD told us that the PK/PD data (which he kept saying was coming very soon) was what was needed to get the trials going. They finally got the PK/PD data (after unexplained months of delay) and subsequently filed the IND. I'm skeptical that they suddenly came to realize that they needed to do genomic analysis before moving ahead, thereby voluntarily delaying the trial. My take on the PK/PD data was that it did not answer all the questions they hoped would be answered. I'm not a scientist, but it seems to me that while the results of preclinical work and the Ph2A clinical results provided some reason for optimism, the long-awaited PK/PD data was not compelling enough to give them the confidence they hoped the data would provide, hence the post-hoc analysis to try to find a silver lining. I certainly hope A273 provided clinical benefit for various CNS diseases, as patients desperately need something that improves their condition. But at this point, I think the jury is still out. I fault TGD for the current stock price because I think his communications with investors sucks. I appreciate the need for companies to be somewhat conservative in their public announcements, especially when dealing with the FDA, but TGD always acts like there's something to hide.