Clinuvel Pharmaceuticals (CLVLY)

[ghmm]

No I haven't either.

I believe the way it works is the agency decides whether or not they grant it at the time of the filing is accepted. When they file FDA has 60 days to accept the application (basically says its complete and they will review it) or issue a CRL (Complete Response Letter). Along with that they'll designate the review as priority or standard.

Since this company misstates things and tells us little its hard to say exactly what they actually did and when they did it. Until told otherwise I am assuming they did not file but hopefully they did. To me the 60 days after is key I'm more nervous about a CRL at this point and more delays! I would highly expect priority review based on the disease and unmet need alone but with current management there is always the risk they didn't dot their i's.