Apologists for HB should just stop. The reasons the FDA had Ariad pull Ponatinib was because of Ariad. HBs ego wouldn't let him get real counsel from a real BoD and other real experts who might have know something about trial design. Ariad was the pony league team of trial design.
EPIC is the trial that brought down Ponatinib. Dosed at the hot 45mg load on naïve patients, vs. the mild drug Gleevec, it looked like rat poison. Great response, lots of AEs. No lower dose cohort or other AE mitigating dosage arm to compare.
That forced the FDA to then review their early decision on PACE. Again, one dose arm. Many on BV and Biomaven and others were critical of the design at the time. PACE had similar AEs. The FDA acted to find out what was safe.
Note, Ariad got a bit smarter with Brig. They had multiple arms at different doses, they tested naïve patients in the Ph 1/2 trial to see if there were AEs, etc. But it was too late for Pona. Iclusig is now on a 7 year odyssey to recover its reputation. And Ariads future was shattered.
Blame HB, he was in charge. Had no-ops on the BoD who just collected paychecks and paid themselves and HB. It's that simple.
The BoD overpaid themselves and the CEO, they breached their fiduciary responsibilities, they doctored their records and coerced and bought off their accuser...I want THE TRUTH!!!
