No surprisesWe all knew TH did not have enough cash to fully fund a phase 3 trial. I even argued months ago that TH's estimated cost on the trial was too low. No responsible company would start a trial that is not fully funded. I am happy they are not proceeding on their own at this point. The program is way to risky. This is TH primary end point:
The primary endpoint will be NASH resolution and no worsening of fibrosis compared to placebo after 18 months as per FDA guidelines.
Didn't a NASH company just recently shelve its NASH program even though it's trial met the exact same end point but they walked away anyways because it didn't show an improvement in fibrosis. I am confident Egrifta will meet that primary end point but I am not cofident it will show an improvement in fibrosis.
The EMA still requires a 1 stage improvement in fibrosis to gain approval. European approval is unlikely unless that changes.
I think this whole NASH program is a reflection on what's wrong with TH management. There seems to be a prevailing attitude that they know more than everyone else therfore they don't need to take advice from anyone. It doesn't matter what every other NASH company is doing TH knows better so they will plow ahead doing it their own way.
I agree with one thing though. They probably couldn't find a partner until the trial protocol was determined. Maybe they will find a partner who knows. Heck, why not partner with CYDY. They will pump the hell out of a phase 3 NASH trial.