Safety is already pretty much a given thanks to existing approvals. Only need to look at the 95% retention rate amongst EPP patients to see there likely aren't even side affects (at least none that are very significant at all).
Efficacy wise, a lot of it we can see just by looking at the before and afters. The primary end point of the study is only 50% of the body surface repigmented, and Scenesse clearly does a lot more than that. It's the only systematic therapy, the FDA are pretty much obliged to approve this so long as theres a decent improvement and no safety issues given the lack of available options and the clear evidence indicating the clinical need for patients.
Management wouldn't go ahead with it unless they were 99% confident they'd get approval. They take an ultra conservative approach, only going ahead with trials and the approval process if they are sure that they'll get approval and sufficient reimbursement. Some like to criticise this approach, but this approach is really why CUV is able to print cash rather than do raise after raise. They would rather do it perfectly than rush and disappoint the market.
CUV Price at posting:
$15.57 Sentiment: Buy Disclosure: Held
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