Ann: Media release - FDA allows world first vitil, page-5

re: Ann: Media release - FDA allows world fir... Not sure what exactly your post is referring to. I never said the MAA would not be allowed by the EMA. And I said consistently that the EMA would approve the drug for EPP - that is, if the solar system doesn't implode before this drug is submitted for approval.

Fact is, according to scientists, the solar system is going to implode on us. I'm not sure which will happen first.

The MAA refers to the EMA exclusively, not the FDA.

The FDA is not technically lagging. It was Wolgen's team who got the ball rolling much later in the US than they originally told investors they would if you refer to old timelines.

The FDA is not going to allow Clinuvel to skip Phase III EPP trials. That is what I said, and I stand by it. Clinuvel tried but couldn't get the FDA to skip Phase II trials - so we had to go through a Phase II trial last year when we were hoping it would be a Phase III.

Historically, the FDA doesn't give much of a rat's arse about European clinical data for most drugs. Are they arrogant in that regard? Yep.

Wolgen made reference in a past letter to shareholders that 'it takes to to tango.' It was clear that the FDA is not progressing as quickly as Clinuvel would like, but when you wait so many months / years to get going with all this, then I can't let all the blame but put on the FDA.

Not that I'm defending the FDA - they are the most anal government body out there.

Best we can hope for is that the FDA allows them to start Phase III for EPP in the US. And the time is ticking on that given this is a seasonal trial.

With the new vitiligo trial starting in the US, I wonder if Clinuvel is still committed to starting a Phase III US EPP trial. I suspect they are.