You seem to think the FDA can or will do nothing until the current AD extension (ATTENTION) is completed (7/31/24). Is that why you're saying no possible approval in 2024 for AD?
Is that what you said there? It read a bit confusingly.
If so, I disagree with you. We may ask for accelerated approval simply with our current data - that collected almost a year ago, plus any interim data we have from the extension. Let's say we submit for that NDA in September. By December we'd have our answer: either they accept or reject our filing. If our AD drug was "fast track," they'd have their decision in 6 months, but since it's not anything special, I think they have 9 months to either approve or not. So that would be by September 2024. The ATTENTION extension will have ended one month before (7/21/24) they'd have to make their final aye or nay decision. So they'd likely have that final extension study data from us....or 95% of it. They'd have a very good idea if our drug is doing good things or not - sufficient to get accelerated approval. If granted, they may require us to further extend ATTENTION, or maybe start a somewhat different "confirmatory trial" .... or require nothing further than perhaps monitoring how patients are doing for the next few years.
Thus, if we submit for the NDA before this October, we could have an approval at the latest by next September.
Similarly, we could follow the same exact schedule for Rett - except it's fast track and thus our accelerated approval could come 3 months before the possible AD approval that I've envisioned here.
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