Replies to post #316500 on Anavex Life Sciences Corp (AVXL)

[Steady_T]

Anavex already has Fast Track designation for Rett.

As I read the Fast Track information, it suggests that the FDA and Anavex have potentially already had discussions about Accelerated Approval. For me the question is when did or does Anavex have the full data analysis that it wants to present to the FDA on the Adult Rett trial. If TGD has been truthful with us, Anavex hasn't had the full data until very recently and that means that the FDA hasn't had the full data either. As I have have said multiple times, the FDA holds all the cards at this point. What the FDA decides will have a major impact on how things unfold.

Here is what the FDA says about Fast Track.

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers

Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA