Exactly, they stated earliest approval early 2023. Sometimes I think it’s a failure to communicate b/w CUV and authorities though I’m not sure who is the main offender. My feeling is CUV thought they had enough but in the end some regulator takes a more conservative view and hence the confirmation data. Issue is why didn’t they just ask for this 12 months ago and it would probably be done?? Yes no wonder there’s no traction. Now looking for ACTH development and OTC lines for a boost?
Ann: SCENESSE in Adolescent EPP Study, page-4
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