Some trials get recommendations to add patients to add to the liklihood that a statistical benefit will be detected if one exists.
Is it possible that Seamless would get such a recommendation by DSMB?
For the last couple of years the succesfull ones have been stopped as soon as DSMB at their peeks detects any stat significance. We too may be stopped early and qite frankly I woiuld prefer for that to happen rather than have wait to the end, most drugs have an ugly tendency then to dissapoint like what happened for ONTY and AEZS. I think Sapa is so sturdy it could give a stat sig peek right at this time. Then its a 30 bagger if not even more. Thats because sapa has been much more extensively studied and WORKS opposed to more unreliable Products like sophisticated kinase inhibitors, pip derivatives and immunotherapy in general.. Sapa is a cyto With extraordinary relineiecy towards adverse effect, and even in the tumors where the bazooka Cisplation is the only cyto that Works, we recently learned that Sapa is way more effective. So approved Sapa could potentionally treat a Whole lot of subroups, and we will be Rich.
Sele is a joker, I like the reumatology part and it still has somebuiting force in difficult tumors, no doubt.
yes i do. I've seen it in other studies. Its not necessarily negative. Obviously it extends the study. Just curious if it was possible here.
Predefined approval usually means hazard ratio and statistical certainty. Increasing patient #'s allow a smaller mOS difference to be more statistically meaningful, right?
I seriously doubt it. From what I see, the statistical benefit will exceed the 27.5% criteria set by the SPA along the entire curve. I wouldn't waist one minute thinking about that. I think Accelerated Approval is more likely.
Sentiment: Strong Buy
Live To Live ~ In addition to referencing where I can find the 27.5% criteria you allude to above, please tell me if you can, is the percentage a cumulative spread, in other words an average across the curve or is it a demarcation that sapacitabine can't fall below at any point across the age spectrum?
Is your thought of "Accelerated Approval is more likely" based on the following?
(Excerpt from FDA's website)
Using surrogate or intermediate clinical endpoints can save valuable time in the drug approval process. For example, instead of having to wait to learn if a drug actually extends survival for cancer patients, the FDA may approve a drug based on evidence that the drug shrinks tumors, because tumor shrinkage is considered reasonably likely to predict a real clinical benefit. In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer. The drug company will still need to conduct studies to confirm that tumor shrinkage actually predicts that patients will live longer. These studies are known as phase 4 confirmatory trials.