Replies to post #44561 on Biotech Values

[AlpineBV_Miller]

If they were to make approval conditional on successful data from 9902b, That's Subpart H/accelerated approval. The only way they could do that is approve based upon TTP but I think that's a stretch.

They can do a full approval conditional on the completion of 9902b, then worry about what to do with it if 9902b turns out negative. This is a fine line I know, but it is an important one.

[gofishmarko]

>>> From strictly a bureaucrat's point of view, it is possibly to argue that survival results from a single trial where survival was not the endpoint is really a surrogate for confirmed survival proof. <<<

You've got it just exactly backwards. What the bureaucrats have given us is a bunch of oncology surrogate endpoints with a mediocre record , or no record at all , of correlating to clinical benefit.

The endpoint we're interested in here is death , not survival . Survival is the beginpoint. No surrogate marker will ever correlate perfectly with the future time of death of a cancer patient. The only ones that would even have a chance would be things like a flatline on an EKG , or maybe the buzzards , and they're no good because they don't save any time in running the trial , which is the whole point of surrogates in the first place.

Statsig improved survival in a single well-controlled Phase 3 trial , in which survival is not the primary endpoint , is a better "surrogate" for survival than any other surrogate ever will be. Only someone with a bureaucrat's point of view fails to see that.