I think it is possible after Angelman but more importantly a favourable outcome in the post-phase 2 meeting with the FDA for Phelan McDermid syndrome which is slated for this quarter.
- Agreeance on what the protocol will be for the Phase 3 study (which would be similar for other indications)
- A modification/simplification for the protocol for the subsequent Phase 2 studies in other indications
- Subsequent to the meeting - the additional Phase 2 indications will be announced and will move as soon as possible
This gives a clear roadmap for commercialising NNZ-2591.
Acadia, page-782
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