IFU, pf course not. The PIII proved that the PII data was correct because it resulted in STAT. SIG. improvement of 70% on SOC on 3mg/Kg body weight dosage stand-alone. (See PPHM PR).
Unfortunately the data that came in AFTER the Sunrise stop was no longer blinded and hence not fileable to the FDA.
And by the way that wasn't the statement. The statement was the Opdivo was NOT and even IS NOT able to beat Doce+Bavi. They just got lucky, or maybe helped luck a little - who knows -, that that combo didn't get approved first. I figure that if you have a billion dollar pipeline hanging their in new Imuno-Oncology you don't let things get in the way if you can.
Peregrine Pharmaceuticals the Microsoft of Biotechnology! All In My Opinion. I am not advising anything, nor accusing anyone.