RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Designing the basket trialsBelieve it or not jfm1330, if slow enrollment is the issue with not seeing efficacy, that gives me comfort as compared to some other issue that isn't overcommable. As has been pointed out here already, the trials are messy, patients are in poor health, and the effort required from the patient just to keep up with the trials helps me get comfortable with challenges in enrollment, because it seems they can eventually be overcome with time.
One thing is clear, they are not trying to hide their lack of willingness to talk about it. At one point, I recall Paul half asking, half stating to Christian, we aren't ready to talk about that are we, of which Christian confirmed.
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