Anavex Life Sciences Corp (AVXL)

[skitahoe]

I'm no fan of the FDA, or any of the other regulators for that matter, I believe that the process for approving products could be streamlined tremendously. That stated, you cannot get a product approved if you don't submit for approval.

Many companies are choosing to go for Europe, the UK, etc. first, in the belief that it's easier and post approval elsewhere the FDA will approve based on observing benefits elsewhere, in addition to what's presented from clinical trials.

I'm of the belief that if the regulators won't change dramatically, they ought to at least do what they did with Covid19. I'm suggesting that when they can clearly see what appears to be a substantial clinical benefit, issue an EUA for the product, gather additional data from its use under the EUA while the million page application for approval is being developed. Finally consider it all as full approval is considered. If benefits expected from use after the EUA just aren't there, unless something new is found to be of benefit, the product should not be approved and the EUA cancelled.

I'm only suggesting this for devastating or potentially deadly diseases, and I believe that ALZ meets that criteria. I believe the reduction in brain shrinkage should be a sufficiently positive indication to make such a determination. Even if the European filing does occur this year, as it should, it will be this time next year before an approval is possible. If an EUA were authorized, the product could be sold and up to a years more experience would be observable in far more patients. If benefits are clear in the EUA, the adoption of the product should come rapidly worldwide base on the evidence. Companies shouldn't need million page applications to gain approval of what is obvious.

Gary