I guess my point was more along the lines of don't attach too much importance to it beyond that it IS a positive.
and that was the significance I attached to it...its a huge positive IMO.
Saving 24 months is significant dollar wise to the company and certainly to folks that need this treatment. I dont think Church was BSn me when he said it was the FDAs mindset there is urgency to get treatment for HCC out there ASAP, hence the move straight to P3. Must have been something they saw they liked a lot from P1.
Again I will say 33% was the number they agreed upon satisfying the FDA and it was also a number the company was comfortable with. I think the trial was designed by some of the best in the world, not to be a coin toss on the chances for success. In view of this JMO, 33% is going to be cleared with air to spare.
"Orphan drug status is an acknowledgement of the significant unmet need to develop a new treatment for patients with primary liver cancer, a life threatening disorder for which today there is no effective chemotherapeutic standard of care. We look forward to working with the FDA and other regulatory agencies to make ThermoDox® available to patients as soon as possible."
That's absurd!!!! Of course the importance IS that it is a positive. That in and of itself IS meaningful. The "don't" in this statement is the absurd part.....
I guess my point was more along the lines of don't attach too much importance to it beyond that it IS a positive.