That's about it.
Some apologists here don't seem to think confidence in Ariad or Iclusig has changed. They would have to deny Ariad's stated position that the company 'must restore confidence in the Iclusig'.
Maybe the science hasn't changed, but everything else has. Pona eligible patient population - a fraction of what it is was, AE's undeniably up, financials halved or worse. Label hammered. Dosing trial underway, again. Only a third of patients returned after suspension, and many on 15mg, because of lost confidence. I consider those fundamental changes. Someone will dispute that with, 'the fundamentals are the same!'. The stock is at a weak $6, not the $20's.
Blaming the FDA is pointless. It doesn't fix the problems. Sure the FDA overreacted. Still, here we are.
So how did we get here? Maybe the PACE trial should have scaled up, not down. Who knew? I didn't, maybe somebody should have.
All those ISTs, '113, the next molecule are years away from any meaningful contribution.
The BoD has as much blame as anything else. They needs to follow Denner's lead. Forget 1st line, partner non-oncology INDs. Time is wasting.