I didn't know about Austria. That's news. Holland is the second country online. Germany is only waiting for the final rubber stamp and could be online in a few weeks.
Switzerland and Italy is mentioned as still being part of the special access scheme which I think is a tad misleading. The two countries are hesitant to pay the new price for Scenesse because that have gotten used to the compassionate use price. However, Italy is now paying app. $19k per implant and in Switzerland several insurance companies have agreed to pay a new higher price too. Maybe not the full $25k like we see in Germany. But still a higher price. Clinuvel calls this a continuance of the special access scheme but we will se higher revenues deriving from these counties nonetheless.
In the coming months we will see the European countries go online with Scenesse as peals on a string. GB is slow because of NICE bureaucracy but it will be the most significant achievement for Clinuvel as GB is one of the major - and in many cases the major - reference countries in the EU. When we get the news that NICE has received formal referral we will still be looking at app. 5 months of bureaucracy before Scenesse could be formally reimbursed in GB. I expect it to happen in January or February 2017.
In the mean time, Clinuvel will negotiate the final price in Germany in the coming months and I expect it to settle at $20-22k per implant. France will most likely follow Germany and the Scandinavian countries are known to be fairly progressive in allowing new medicines, so I expect them to follow soon too.
All in all, the next many quarters revenues will go up significantly while we wait for the next big market to open up: The US.
As you write, the patient meeting in October is indeed open to the public (at least as a webcast) and I expect the company to file the first module of its NDA for EPP under rolling review around EOY. If we - and the patients - are lucky, we might see PDUFA sometime next summer / autumn. Distribution and uptake should be an easier task in the US than in Europe and hence also quicker once approval is granted.
Vitiligo is the elephant in the room. It seems from the recent newsletters that the company is aiming at ph3 trials without another ph2. This would be significant.
Everything is happening slower than most investors anticipated and I reckon that many are getting bored, frustrated, angry, nervous, freaked out or spooked because their investment hasn't yet made them rich. This company has a history of messing with investors minds but that's biotech right there. It takes time. And then more time.
IMO this is the best time ever to be in Clinuvel and those of us who have been here for years will soon begin to see the price action we have been waiting for. New investors are the lucky ones. Hopefully, patients will soon all be lucky, too.
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