I agree that the preliminary trial achieved its goal of generating data that will convince the FDA to sign off on a P3 trial.
The method of analysis, a repeated measures model, is a very standard modeling approach. There is nothing ad hoc about it. Of course, the model wasn't pre-specified, which is an issue if one were looking for approval. All CYDY wants is the ability to move to the next step.
One thing that keeps coming to mind when thinking about the call is how much more positive Dr Recknor was on this call. He alluded to a great group working on the BLA. He said FDA communication is better. He was positive on the dosing issues. LH data good. . It seems like they have developed much better relationships in cancer. I was a bit surprised that BP partnering potential came up. It seems things are more active on this front. I would not be surprised to see a partnership deal this summer.