RE:RE:RE:Shelf Prospectusfredgoodwinson wrote: Apologies Lifegoeson - just picked up your post.
Just saying that with the benefit of positive results for a statistically significant number of Triallists - i.e. at least 30% CR out of total planned enrollment - and pending receipt from the FDA for approval of a requested truncation of the Trial they might at that particular time slow down or even pause recruitment.
In truth I have no idea as to what would happen with the residue of the Trial in such circumstances.
That 30% figure for approval was speculation given by Dr. Kulkarni at a TLT shareholder meeting a couple of years ago. He also qualified it that others would need a higher rate of proven efficacy. I took that to mean a hint directed at the FDA. My guess is if it were to be 30% then there would be a higher probability of a phase 3 trial to confirm the findings are consistent when applied to a greater number of patients. I don't have one of those Walmart Chinese crystal balls some of you other posters use to predict results so I have to do it the old fashion way and wait wait for the trial doctors to release the trial data. It would appear the market also has no faith in crystal balls as it too is waiting for clinical data.