Clinuvel Pharmaceuticals (CLVLY)

[FarmaZutical]

Upcoming catalysts for Clinuvel:

I expect the filing of the rolling NDA to be finished by July. Perhaps even before but don't count on it.

Then we will most likely get a PR stating that the FDA has granted priority review and that a PDUFA goal date is set in Q1 2018. My bet is February 28th but it's just a guess.

Approval is a lock IMO. And fairly quickly distribution will begin through the expert centers and sales will ramp up.

Meanwhile, in Europe, I expect more counties to come online this year as the price has now been settled with the German AMNOG.

The next quarterly coming out tomorrow will most likely be modest as most sales could have occurred late in the quarter and the money not actually been payed yet.

But Clinuvel continues the steady progress and I think we will see tremendous organic growth over the next year.