Add to that
- its a rare disease with no other existing treatment
- there were no adverse outcome to trial participants apart from diarhea (in patients that are usually chronically constipate)
- it has strong support in the Rett community
- Phase 3 results were "robustly" positive
All that doesnt guarantee that it will be approved on March 12 but I cant imagine any situation in which it is totally rejected sending the share price back to RoyalWuff's alarmist $1. In my humble opinion the worst case scenario is delayed approval requiring some re-jigging of the Application.
However everything that Acadia says and does, along with the US market appreciation of their share price tells me everything is on the right track and approval on or before March 12 is the most likely (but not guaranteed) result.
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