Tend to agree about the p value stalling because t
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Posted On: 10/20/2020 12:24:12 PM
Re: nmbr1stckpckr #62260
Tend to agree about the p value stalling because the SOC has improved, and the younger, healthier patients are simply not facing the same mortality rates. The SA article yesterday was right in line with what I have been thinking recently as data accumulates on younger patients.
As for what to do now- I just don't know. I think we're in a really tough spot going forward. As patient populations grew younger, hospitalizations declined dramatically, so there aren't as many S/C patients to treat. With so many MAB's in the game now, it's hard to enroll quickly, and I don't believe for a second that we'll complete the 390 by the end of the year. Add a couple of months to that, wait 42 days, compile data....it's a tough scenario.
On the other side, unblinding now doesn't seem to have the backing of the DSMC, so we'd really be throwing a Hail Mary at the FDA. That doesn't have much of a chance, and going to 390 is going to be too late, IMO. If I had any confidence in p value improving at 293 in 4 weeks, that would be obvious, but I think the chances of BOTH of those things happening is quite low, and that's what we need.
As for what to do now- I just don't know. I think we're in a really tough spot going forward. As patient populations grew younger, hospitalizations declined dramatically, so there aren't as many S/C patients to treat. With so many MAB's in the game now, it's hard to enroll quickly, and I don't believe for a second that we'll complete the 390 by the end of the year. Add a couple of months to that, wait 42 days, compile data....it's a tough scenario.
On the other side, unblinding now doesn't seem to have the backing of the DSMC, so we'd really be throwing a Hail Mary at the FDA. That doesn't have much of a chance, and going to 390 is going to be too late, IMO. If I had any confidence in p value improving at 293 in 4 weeks, that would be obvious, but I think the chances of BOTH of those things happening is quite low, and that's what we need.
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