Replies to post #32766 on Ocata Therapeutics Inc fka OCAT

[fordwill1953]

The concept of a Phase I/II elsewhere can sometimes lead to an immediate application to the FDA to approve a Phase III trial. I will of course not pound the table to make this point. It goes back to the data and the statistical results.

I am thinking out loud that they are including the second part of the trial to help them with a full Phase II or set up... a Phase II/III combo trial.

With the FDA demanding 2 independent phase III trials showing significant statistical benefit, I've seen a shift to combining trial levels in order to speed up the process.

But, Rocky, I am already in your debt with your gracious, constant sharing of information and only post this as a possibility down the road. Let's just keep this in our back pocket for the time being.