LTG,
WRT "After phase 1 results, it was the FDA themselves that suggested they move straight to a much larger trial...Phase 3"
...
I questioned this awhile ago because it seemed too good to be true. I am totally assured, personally, that it is true, with several people I trust.
HOWEVER,
>>"Reason being is, HCC is such a serious problem, there is urgency in finding treatment"
is IMO false - also based off interviews of those people who assured me the first fact was true...
The reason appears to be that ANY phase 2 trial that would have been conducted would have been structured almost exactly alike to HEAT, although probably with a much smaller N.
Even with an 80-or-so patient trial, the timing would have been only ~24 months less than we are experiencing now. So we would have gotten final ph2 results approx 1Q11, and only NOW been really gearing up with "final enrollment" for the then-to-be-conducted ph3. And that trial would probably not yield final results until eo2015 or so?
It sounds like in reconstructing the ph2 planning meeting, the FDA simply asked Celsion mgmt why they didn't simply run the planned study as a ph3 and save ~ 3 years. (Add in the fact that we are now registrational in Europe, China, S Korea, and Taiwan and the trade off doesn't seem so bad!)
You can believe or disbelieve this as you please. My point is simply that 1) yes the FDA initiated the suggestion to skip ph2 and 2) no, it is not nearly as important-sounding as it seems.
Best,
Trond
