While there is a only modest chance Ariad might be able to dilute more stock and somehow survive independently, i.e. all the stars line up with '113 and mN, and Pona recovery boosting pps enough, there is nearly zero basis for a broad Pona 1st line label, beyond T315i, AP and ALL maybe. (Japan is a $50M upfront deal at best according to Ariad, it won't save the company. The trial is active, but oddly, not recruiting).
Denner is realistic about 1st line. HB is not, IMO. As of today, the front line trial was killed off because there is not chance that it would have been approved. We aren't even 2nd line approved, and we must conduct a 3 yr dosing trial just to learn safe doses.
Safe dosing is the key to why 1st line is out. There were several approaches laid out for addressing AE's: 1) treat the underlying AE diseases 2) Screen out poor AE candidates, 3) dosing. 1 and 2 are essentially the same and eliminate 30-40% of the patient pool. Dosing will help, but the main problem is the drug itself. It likely is as Ariad says, a problem with the drug class. Can't fix that. And at lower doses, Pona safety may improve, but efficacy deceases to where gentler Gleevec is a better choice still.
Amp, Cortes wouldn't prescribe it for anyone if one were to want it, 1st line, either. He 's out of the 1st line Pona trial biz I believe.
So how in the world can one think Pona will ever be 1st line? Wishing won't make it so. There is zero justification for it.
No one is prescribing Pona 1st line (ex-T315i). AE considerations trump efficacy is the drug decision.
