Hard to say about the FDA.
So many changes in their approach to drugs that could affect how the FDA sees the existing trial and OLE data.
They set up the CNVP program to get critical drugs approved rapidly for example. I doubt the 2-73 will be selected for that program since there are so many applications for a voucher.
The ABCLEAR data is post hoc which makes it a hypothesis, however the genes identified are clearly linked to plausible disease process. The very large numbers of subjects identified by those selection criteria and the very low P values make the correlation very strong. That data certainly can be presented to the FDA. How the FDA chooses to value it is another question that remains to be answered.
If Missling were to get a P3 trial started soon I think the FDA would look upon that very favorably in terms of a conditional approval. How fast that approval process would be is an open question.
I think that getting a pediatric Rett trail underway would be a good choice for the company. That last Pedi trial was a 12 week trial, so site set up and subject recruitment would be the longest time factors in completing that trial. The pediatric voucher is still out there if pediatric Rett were to be approved first in the US.
Missling has a number of choices in front of him. I suspect the meetings with the FDA will guide Misslings decisions on how to move forward.
Stay tuned.
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