I haven't looked up the definition or guidance with the FDA. Does it allow Anavex to sell A2-73 to the other adult Rett patients under the Expanded Access/Compassionate use?
And if so, will the insurance companies recognize the EA status to cover them under their policies?
Expanded Access is to generate buzz within Rett community and to get them talking about it and subsequently pressuring FDA to approve. The more people in it experiencing benefit, the more FDA will take notice and be influenced. Once approval overseas, that will also pressure FDA, rather than making American patients waiting additional years to see it approved.
FDA guidance told Anavex if wanna get Rett approval after Avatar then change Avatar to a Ph3 and use RSBQ-AUC. Why change to Ph3 if no plans to get approval? That's an indication to me. Anavex wanna get this done now to steal Trofenitide's thunder. Anavex also have fast track and bunch of other designations from FDA. They <3 Anavex :) Anavex has complied w/their requests for adult approval now and child approval at eoy or early next year.
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