RE:RE:RE:RE:RE:RE:Bagholder, bagholder, bagholder...The most directly comparable would be Valstar (single arm open pabel, fewer pts) but unfornateky thats 1998 so hard to get data.
Its relativeky unusual for approval on one ph iii in general, but exceptions are made in cancer.
Nivolumab's rolling NDA was arguably thin when it started, but obviously the ongoing trial program is vast.
Believe Shire tried and failed to file for approval on only 1 ph iii with kifitegrast, but memory hazy on that one. Also obviously end-point definition sucks in dry eye, which was the bigger draw bacj for Shire.
For TST ultimately I believe it comes down to the 3y+ duration in responders - that is real and undeniable. If there was only OS data it would be a problem, but PFS carries more weight in thin filings.
Will try to think of more examples...