Why REGAL may not end for months despite being at 78 events 3 months ago
So, I have seen almost nobody bring this up in discussion. I only saw it myself because CW brought it up on over on stocktwits, and even then it wasn't a post but rather, it was buried in a response to someone else's question.
I'm paraphrasing here but the general idea is that while SELLAS is informed within 24 hours of an event, the sites gathering those events are severely lagged. This is due to the protocol for how patients will be checked up on during the trial. GPS patients are checked as they receive their treatment (every 3 months), but BAT arm patients who (i think) are over 1 year into the trial are only checked in on once per year, so annually.
It may very well be that we are beyond 80 events and simply waiting for that annual (or 3 month) check in, which is likely a rolling calendar.
If BAT patient died in August, but they were checked in July, that means waiting 11 months to find out.
Now clearly they didn't expect the trial to go this long, but this seems like a huge problem with the protocol.
Not to mention, if GPS is working as intended, then we may have a strong set of cured patients who won't die any time soon. Therefore, the checking in more frequently will be of little use to ending the trial.
If only 5-8 BAT remain, we are not just waiting for two of them to die, but perhaps waiting 6 months or 8 months or 11 months just to find out after the fact.
Being only 3 months removed from the 78th event we are left with a durable group of patients (from both arms) and a protocol that will blind SELLAS from that event for anywhere from 3-11 months.
SELLAS refusal (seemingly) to end the trial and risk losing an ounce of statistical currency has put us in this position. And like, I kinda get it. They know 009 data is scheduled for Q4 and I'm sure internally they would like both shoes to drop at the same time.
Pragmatically speaking, this has me extremely worried about my 2027 LEAPS , which I thought after the 78th in May was a conservative investment. I have since watched their value erode and are now faced with the possibility of the 80th not even being announced by January (insane, I know). But that's the protocol and it's awful. And nobody is talking about it.