Replies to post #300903 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

raja

I am only guessing, but I believe Dr Missling is going for a "basket approval" and is waiting to hear from the FDA! That could be the reason for not designating the PD trial until clarity cones forth. Little ANAVEX is on the verge of becoming an important BIG PHARMA entity!


Mysterious are Missling's ways. (You may be guessing right)

The FDA has a process for V&V=Verification and Validation. (methods of proof).

Verification means conducting a review to confirm a process was performed correctly. Verification answers the question "How do you know it actually happened?"

Example: A manager in a cookie factory reviews production records to confirm that the cookies were baked to the temperature described in the recipe.

Validation refers to the requirement that a food processor use scientifically proven methods to control a hazard. Validation answers the question "How do you know it works?"

Example: A food safety manager collects scientific research to demonstrate that the cooking temperature used in the recipe is effective in eliminating harmful bacteria in the raw product.

IMO, Dr.M. is doing both product verification, where he measures efficacy, etc using conventional CNS disease methods and criteria trial methods. AND/WHILE, he is simultaneously doing an MOA validation of the CNS Cellular Homeostasis claim (BASKET TRIALS APPROVAL)

Actually, validation of the MOA claim is much more important than the individual CNS disease results, for obvious reasons. In fact, ironically, the respective CNS disease treatment claims actually become evidence of the MOA validation claims. I have wondered from time to time if this is why he has been staying off the PR radar , until now. Is this a sign he is ready to show proof by both verification of CNS disease efficacy claims which then provides evidence of validation of the MOA claims. IMO, the MOA claims impact stretches well over the horizon.

[Pazzo1212]

Sorry if this has been addressed before, however I’m wondering if there are recent examples of the FDA granting ‘basket approval’ for a first time drug?

There are drugs that are used for multiple uses, but only after they were approved for an initial indication.

Plaquenil, for example was originally approved for malaria, then lupus then rheumatoid arthritis.

But what new drug was ever approved as a basket right out of the gate?