SPCEO1 wrote: I have been assuming the trial is ongoing and that they would likely have to announce if it had ended, but Qwerty no doubt is correct that this is not the case. However, Paul's effusive comments on the Canaccord Growth Stock conference call are a good hint that the trial was ongoing at that time. Now, he could have been effusive because even though the trial may have stopped, (I really don't think it had at that point), they had already collected enough data to know they have something very intriguing on their hands in TH-1902. So, a trial stoppage would not necessarily be a bad event anyway.
On the negative side of the equation, the NASH KOL event could be a signal they have encountered some issue in the cancer trial and are reversing course from the July partnership announcement since they would want to keep NASH if something going badly in the cancer trial showed there is no future for TH in cancer.
Both the speculation that the trial has stopped already or that it has hit a wall of some sort are not really very good speculations in my view as the hints we have really do not support that. So, my best guess remains that the cancer trial is still ongoing and the NASH KOL event is not happening because of problems with the cancer trial.
If I counted the weeks correctly and if TH has stayed on the original 28 week expected timeline for the pahse 1a, then the trial should end in the first week of October if it is not halted early dor reasons of already meeting the MTD or other safety reasons. Hopefully, we can get the preliminary data from the trial by late October or early November.
stockman75 wrote: Yes thanks for the Q&A. I had been wondering how this worked as well. It seeems like the board in general (many here) have been assuming we haven't yet hit MTD. But that is an assumption not necessarily true.
juniper88 wrote: Thanks, yes that helps a lot.
qwerty22 wrote: It's difficult from the outside to know exactly what triggers an announcement but generally it seems to me companies like to announce a set of data, so MTD, toxicities and efficacy. So I don't think companies are obligated to announce MTD as soon as it's reached. MTD can be thought of as a stand alone thing but it makes more sense when you know the doses an efficacy signal is kicking in at as well. MTD is just based on the DLTs from the first dose each patient receives, the overall toxicity profile is based on all doses, that means technically MTD can be the first thing the emerges, but given how late they have this as a milestone announcement I'd guess they aren't rushing to announce MTD as soon as it's reached. I'd expect it's going to be part of a bigger data set. Also Paul's comment that he didn't want the rush things and make an announcement based on n=1 also suggests they want to have the "right" data set before going public.
So yes can't help with the paranoia, MTD might already have been reached but all this might mean alternatively they are also sitting on some shrinking tumours by now and not announcing those. Does that help?
juniper88 wrote: A couple of question for those who might know more about this.
1) If MTD is reached then is the company obligated to announce it? What have other companies done?
2) If yes for 1) then is there a time lag between reaching MTD and the announcement. For example, let's say a patient had toxicity on Aug 1 then by what date would it be confirmed that this is MTD?
It looks like another month (aug) has gone by without MTD being reached. But my paranoia nags at me wondering if MTD could have been reached but just not announce or confirmed yet.