moveonup,We still have a couple huge hurdles to clear. We've...

moveonup,

We still have a couple huge hurdles to clear. We've cleared a huge one in recent years: the drug has been proven safe.

The next huge hurdle(s) we have to clear is to get statistical significance in the EPP trial (then later for the PLE trial for off-label potential). Also, a reasonable price point that would encourage off-label usage by those of us King's subjects who aren't card-carrying members of the jet set club.

The EPP interim results showed stats significance were obtained by a particular number of trialists. However, the company did not mention what happened to those who did not achieve stats significance. As someone here mentioned, they won't be able to cherry pick the trial results with the regulators.

So the market is waiting to see some definitive answers as to exactly how many of the Phase III trialists achieved stats significance, and for those that didn't, a clear explanation.

The drug is safe, the drug improves the quality of life, and most patients want to remain on the drug post trial. But, we don't know if that is good enough for the EMA. We have to meet the primary endpoint.

That lovable brit, Sherlock Holmes, would look at the recent news and get ready to whip out his "elementary my dear Watson" on us. That is to say:

1) Clinuvel is starting a Phase II US trial. If the Phase III Euro trial did not give them confidence after they rolled the dice on EPP, would they be dumb enough to start a Phase II US trial for the same indication without having a clear idea Phase III went well? I don't think they would be that dumb.

2) Wording of the newsletter indicates the EMA is giving them very good feedback. In fact, it sounds to me like Wolgen could file for approval concurrent to them doing the EPP confirmatory trial, WHICH IS WHAT THEY INITIALLY TOLD US THEY WOULD DO in Agersborg's podcast interview last September. But, I still predict Wolgen will wait until the cofirmatory trial is done and that data is added to the dossier. He's history shows he's too risk-averse to do otherwise.

Here's the "Wildcard Positive" (that's the old predictive modeling term used by the governement agencies like the CIA that have b.s. futurism jobs in those departments):

EPP results are solid, they meet their primary endpoint, the company gets good feedback from the EMA, and Wolgen pulls a shocker and files for EMA approval before the EPP confirmatory trial is done.

Should that happen, this stock will have a big overnight upswing.

But I'm not expecting the Wildcard Positive.

I expect decent, but not ideal EPP results, good enough to get this approved, but the risk-averse Wolgen waiting until EPP confirmatory results are in.

More to add, but it's a sunny weekened here and I've got to split.

Cheers!