Clinuvel Pharmaceuticals (CLVLY)

[ghmm]

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.

Its not that the timelines are unrealistic for a typical company but for Clinuvel. We first got word that the FDA agreed that the data package was acceptable for file in July 2016 and they would begin a rolling NDA. They speak about records this must be one for the longest rolling NDA! I had false expectations of mid-late '17 PDUFA data now they'll be lucky if they file in '18!

My hunch is one of two things
1-The FDA didn't exactly say the package was acceptable.
or
2-They offered FDA EMA data they did not have (such as on going safety data). Perhaps it was an inbetween scenario where they took so long to complete the rolling NDA the old EMA safety data was stale and FDA requested a later cut-off?

If FDA really "deems datasets satisfactory for submission of New Drug Application" then there shouldn't have been a need for MORE data! So one of the two has to be the case.

While I think the drug is approvable given track record of CUV management its at best a 50/50 bet that both the file is accepted and FDA does not find something in the review that results in a PDUFA extension (hopefully not worse!).

As far as risks also could be positive to the upside is how the quarterly revenue numbers look. Granted its not the peak season and we've seen revenues plummet in the "dark" quarters but I (and other investors) will look at year over year numbers. Last quarter was terrible for a new drug launch so what happens even in the off quarters could be a sign of how the launch is really going.