Replies to post #428440 on Anavex Life Sciences Corp (AVXL)

[Steady_T]

I suspect he is preparing the data in a presentation form for the FDA to have them determine if the biomarkers are acceptable surrogates for the AD trial. Anavex has data on other biomarkers that is is recording as part of the trial data that are not currently accepted as surrogate biomarkers.

My guess is that Anavex is taking the sort of accepted surrogate biomarkers and pairing them with the additional other biomarker information to make what Anavex hopes is a compelling case to the FDA. I'm guessing that the gene expression data is significant part of the biomarker information that Anavex is wanting to put before the FDA. Anavex has to make the case that the gene expression is relevant to AD clinical efficacy. That will be a new concept to the FDA as it relates to AD so Anavex is going to have to provide a lot of supporting data for the FDA to accept it.

We have seen documents that show the FDA has accepted the biomarkers that Biogen provided as suggestive of clinical efficacy. Those same documents expressed concerns about how reliable those biomarkers are. Don't ask me for links. They were linked on the board and I didn't save them.

The point being that AD surrogate biomarkers are not as cut and dried as many think. Anavex is plowing some new ground as well as using the existing surrogates.