Clinuvel Pharmaceuticals (CLVLY)

[FarmaZutical]

PDUFA date secured with priority review: July 8th. 2019.
This is a significant milestone and the fact that the FDA doesn't plan to hold an ADCOM meeting is both surprising and reassuring.

For new investors:

Clinuvel's lead compound, Scenesse, is already approved in Europe by the EMA. It's marketed in numerous EU countries and in high demand by patients. Great Britain (NICE) is reluctant to pay the price but everyone with knowledge about GB knows that the system is broken and that tary are trying to curb expences in any way possible. Clinuvel won an appeal, though, and I assume NICE will cave in March at the final meeting.

New indications are also underway. Vitiligo is headed to Phase 3, a POC in VP is underway in Europe and a 3rd indication will be announced soon.

The Company is also develloping new products. A cosmetic line that will probably be launched soon. It was due last year. And several lotions that are being develloped in Clinuvel's Singaporean lab, Vallaurix.

Moreover, a move to Nasdaq is planned in 2019.

This is a remarkable Company with no debt, loads of cash on hand, strong Growth, big institutional backing and loyal top 20 owners. A brilliant CEO with a vested interest. And soon: FDA approval wich will only be a foot in the door and the beginning of the real growth adventure.

GLTA