RE:RE:RE:RE:RE:RE:TH-1902 pause is no reason to blame management Here are the RECIST rules.
https://project.eortc.org/recist/wp-content/uploads/sites/4/2015/03/RECISTGuidelines.pdf
Section 4.2 describes how you pick the "target" tumours that become the basis of the RECIST measurements. Read the details but basically you are picking upto 5 large, representative lesions. One take on unconvincing efficacy which is better than next to nothing might be a failure to hit these RECIST tumour while still showing response in the many other (smaller) tumours that a patient has. The endpoint of the trial is based on RECIST. Failing to hit this is a failed trial, no matter what other things they see. So stopping early because you are failing by RECIST might make sense and could happen where you are seeing other evidence of anti-tumour activity. This might be what Juniper is describing in his wife. The only problem with this is that restarting the program leaves you in exactly the same position you are still going to be judged by RECIST and you still need to get over that hurdle.
The drug doing a reasonable job against smaller tumours and a poor job against the larger tumours (include the RECIST target tumours) might be a scenario here. It would help if they told us.
Wino115 wrote: I think one problem, oddly, is that the hurdle being fairly low for these patients at this early trial stage (just see 2 out of 10 confirmed responses), that it would be plausible to think you might actually see that even amidst seeing 8 straight non-responses. They might not actually lead you to think you might not see that Prostate guy tomorrow and the next day. It almost would be a clearer mislead if they had never seen any activity in the early part of the trial. But they did somehow. It's sort of a shame because had they hit that, they would have been able to get far more sophisticated around these exact issues to do this exact optimization they're doing in the Phase 2 protocal for one indication. Play with 2 or 3 dosing regimins, a few patient selection tilts, and maybe you get to the 3 out of 10 to make it commercial.
SPCEO1 wrote: He did say "we think" but Juniper is correct - Given anyone paying attention knew they should have accumulated enough results by then to know where the trial was headed, it was likely irresponsible to say even that if he was not really pretty certain a good result ultimately would be revealed. But maybe they had seen some good results at that point and he just got one step ahead of himself. Based on the pause, one would have to think that was not the case, but we don't really know what they were looking at in September.
By the way, the same thing can be said about the "a few, several, maybe many" possible indications of the drug working by Christmas comments made in mid August. It is hard to believe Paul was saying these things without an adequate basis for doing so.
juniper88 wrote: Paul shouldn't have said that. Whether he said "we THINK" or "we have", I haven't heard of any other companies making such a grand statement. Why did he "THINK" that? It makes many of us believe that he is seeing at least some efficacy in this open label trial that leads him to think that. He should have known how his statement would be interpreted by many.
palinc2000 wrote:
I thought he said
We THINK we have the Key and I even posted then that I understood that think meant that he was confucting a clinical trial to prove the key statement
Adonis wrote: So Why paul told some weeks early # we have the key of cancer # just after that the disaster happened..