<<FDA would not have approved PHIII if 1st line was not good, IMO!>>
Disagree. P3 has been approved based on the trial results and FDA understands that the results would have most likely been better without the dose switching, close to what was originally reported in September.
First line is crucial IMO, if not very good PPS will take a significant dump and will be hard to partner.
volgoat, no one can infer from FDA phase 3 approval what the first line is or might be.
As one investigator told, with subsequent second and third line treatments of first line trial patients, cause and effect analysis of a drug is by far not as compelling as any Second Line trial result. IMO, the FDA is in tune with this.