You misunderstand my position. I do not believe the DMC found the study to be futile, just the opposite. I believe they recommended the trial be halted for efficacy and the company refused.
Thus, FDA said "say what?, you really want to wait? We recommend that you don't...wink, wink. Say what? You want to go all the way to OS? Your choice but we cannot let you put anyone else on PBO, that's just not ethical. You can have the patients that already consented and no more. If you want more, you will have to run an EAP and give it away, give it away, give it away now. And BTW, you are now formally under review, so we are going to watch every damn word that you say. Every damn day, every damn night and especially at every damn conference and earnings call. You best not bias your trial, baby! Shut the Frack up about every damn thing, you got that brah?"
Linda "understood"
The rationale for refusing would be that they would have limited data to market. Trials stopped early are caught with the data in hand and although a long term benefit can potentially be inferred, it cannot be implied or marketed. Without hitting 50% PFS in each arm, you have no median, without hitting predefined milestones by proportion of patients nor 50% OS you have no survival to market. In August (really July), IMUC looked to be poised to have both, leaving a potentially superior therapy with its hands tied re: sales & marketing of weak data. The market understands median and 2-, and 3 year survival rates. The market does not give much value to an early stop due to efficacy.
