What I do question though - why the change since Dec 4? Could it be the Peer Review (not available at the time of the 4 Dec announcement) has made Gary more confident in what the interim data shows? Why do you think only a week later he is now saying we can go to the FDA for planning the Ph3, after results in March?
I know I'm answering my own question, but what I took out of Gary's webinar to investors yesterday, following the Conference presentation, is that our interim data has already established what we know will be a primary endpoint for the FDA and our Ph3 - and that is TSS. Gary made a big point about how TSS is an absolute FDA favorite for these trials, and our interim data already demonstrates a nearly 50% of our trial participants hitting a TSS of -50, and an overall median change of 41% across the trial. That is pretty special.
So that leaves us to develop a secondary endpoint. Whilst spleen size may be one such measure, Gary made it clear that there are options available, and hence we will be discussing that with the FDA.
Subsequently, I really don't think it is going to be that hard to agree Ph3 endpoints with the FDA, well before our Ph2 is complete.
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