RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Designing the basket trials I think this is mis-reading the comment about new centres. He didn't express any urgency around this. He didn't actually say they were looking to get centres opened quickly, he said they were doing paperwork. That expresses no urgency to me whatsoever. My memory of doing that particular task is it's a multi-layered bureaucratic process and there's no rushing it even if you wanted to. Maybe I'm wrong but this is for expansion (if that comes) in 3-6 months time not to solve an immediate problem.
Why would you fear so much to talk about enrollments numbers?
Because one thing is never enough. Enrolment is slow, that's just an outright negative. Enrolment is fast or on-track. So why aren't you telling us about the efficacy signals, you must have efficacy if you've enrolled people. There are no efficacy signals. This drug is a dud. If you're dosing plenty of people tell us about safety. You must be able to give us an indication of the safety profile by now. You hiding something? This must be a toxic drug. You don't get to say one thing because enrolment on it's own in a non-blinded trial is still hiding everything else.
I really think it's an all or nothing thing. You decide to wait for certain milestones and you say nothing about the ongoing trial or you prepare to open up on a half-baked data set.
Just try to imagine they say enrolment is on-track. Would you really be satisfied just knowing that?
jfm1330 wrote: I was so disgusted with the press release last week that I just listen the parts of the CC. Today I listened to the whole thing. The thing that struck me was their planned refusal to talk about anything from the actual trial, especially enrollment numbers. Why would you fear so much to talk about enrollments numbers? I saw only two possible answers, first, they are very late again like in phase Ia, and they do not want to look bad because of that, second, enrollments numbers are good, but they don't have efficacy data to disclose, at least not yet, and this would also look bad and would be very worrying. That being said, my sense is that the problem is low enrollment numbers. This feeling is backed by Marsolais saying that they work to open new centers. That would be in line with enrollment problems, ans in line with the problems they had in phase Ia where it took twice the initial timelines given by the company. So it seems to me that enrollment is the problem. I suspect that it is so low that it would be almost impossible to have two partial responses in a given cancer type at this point. Another fact that seems to confirm that is the new timeline they gave for enrollment completion. It is now the end of Q1 2023, while before it was the timeline for study completion. They also pushed the timeline for release of possible efficacy signs.
To me they really looked like people wanting to hide the slow pace of enrollment. Now, if true, it leads to another question, why is pace of enrollment so slow? Is it competition with other drugs aiming at this class of very advanced cancer patients? Is it the lack of convincing published efficacy data, because the more convincing efficacy data they will release, the more it should attract patients to give TH1902 a try. Now they have almost nothing, so maybe patients prefer trying something else. I don't know. They look like people trying to hide a problem while working hard to fix it. One thing is sure, they looked like people willing to talk about anything but what is going on in phase Ib. I tried to figure out another reason for the unwillingness to be more open, and I found none. They really look like a company working to fix a major problem, trying to buy time by saying nothing. I did not see any strategic reason for saying absolutely nothing if everything would be just fine. If everything would be fine, why would they hide the number of enrolled patients? Marsolais was really like no no no, we cannot talk about that as if it was critical to keep it a secret.
One thing is sure, this CC was a success in confusing me totally. If they wanted shareholders to be sure of nothing about TH1902, they got it perfectly. At least they are good at something