Anavex Life Sciences Corp (AVXL)

[Gator328]

Actually, the FDA is facing a backlog with site inspections and other bottlenecks that is causing delays with drug approval. To date, there are 48 drugs that are facing unanticipated delays and while the good news is that the FDA is starting to get back to a regular cadence, it's going to take some time before everything is back to normal. Pandemics can sometimes do that.

I don't think the FDA wants bad press, but you seem to think that the FDA is going to prioritize Rett over any of the number of other rare pediatric diseases that are deserving of the agency's attention (and have equally powerful advocacy groups). There is nothing in my post that I believe creates fear, uncertainty, or doubt. I am hopeful that Rett will be approved. I just believe it will take longer than some here are speculating.

Maybe I'm wrong. Wouldn't be the first time and it won't be the last. I'd love to see Rett approved tomorrow. But I've also been here long enough to know that everything always takes longer than expected.

The fun part is that we'll know soon enough whether I am correct or not. My belief is that we'll see a decision with Rett syndrome sometime between May 2022 and September 2022. Others think it'll happen sometime between September 2021 and December 31st, 2021. Time will tell.

Stay safe, Fireman. I enjoy your posts and perspectives, but in this instance I think you're wrong to state that it's absurd for me to believe it will take another 9-12 months for the FDA to approve Rett for pediatric use so that AVXL can get the priority review voucher.