Yes. "Sufficient" is the key word there. No one knows for sure how the FDA is going to rule once they get all of the data for the NDA...so Anavex has only one shot to prove their case!
Everyone knows that a successful P3 trial is worth its weight in gold because it's a double-blind, placebo-controlled study...and the FDA will value those results over all of the other trials.
If it weren't for the Covid delays, I believe we would've had the Rett trials finished and approved by the FDA by now...which was Dr. Missling's original plan.
It would be a lot easier to get the FDA to approve our AD application if we could include all of the data from a drug that is already approved for Rett. Unfortunately we can't do that because, like I said, we had Covid delays.
But we can do the next best thing...which is to submit the P3 data from the Excellence trial...so I think it's smart to wait a few more months until it's finished.
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