Clinuvel Pharmaceuticals (CLVLY)

[FarmaZutical]

I’m not expecting any bad news. Only possible delays before good news.

I don’t think there is much risk the FDA will reject the NDA. The patients meeting, acceptance of the data package and the carcinogenic waiver bodes well. The FDA wants to approve but needs more solid proof of efficacy to do so. The EMA post approval data will be the last piece in the puzzle and I expect Clinuvel will be finished analyzing by February.

My expectation is that they will file the full NDA in April, 2018. 2 months of validation and the formal review can begin by July, 2018. That brings is to H1 2019 for possible PDUFA.

In the meantime look out for possible NICE approval (reimbursement) in GB and new European countries online.

The company is notoriously misleading the market with unrealistic timelines and delays. But the risk of failure is very limited IMO. It’s just a matter of time.