RE:RE:RE:RE:RE:RE:RE:RE:New Corporate Presentation Out I'll tell you how I'm parsing Paul's comments. First some facts and inferences and assumptions underlying it.
Drug cycle takes 3 weeks.
In the past Christian has said real world stretches that to 4 weeks
I'm going to stretch it a little further to a month.
1b start mid-May
Complete enrolment target date - end Q1/23
Run time ~ 10 months
10 patients per cancer
Could infer from that 1 patient per month from each cancer
And we know the target for 1b is 2 responders from 10
Christian said "We're trying to ensure that the pace of recruitment is similar in all cancer types."
They aren't doing that for aesthetic reasons, there's no business reason to holdd back recruitment in each cancer to a single rate. They must be doing that because recruitment rate is baked into the protocol. It would make sense that's for safety reasons. Given the above 'facts' it most likely means recruit one patient, run the full cycle (1month in my assumption) then recruit the next. If anybody has a better explanation for why he said that I'd love to know. So what I think he real meant is "the protocol says we can recruit one patient at a time in each cancer and we are trying to ensure that happens for every cancer"
For me this is basically how the trial works. So let's look at Paul's statement in relation to that. "Mid-Aug to end of year"
Well Mid-Aug is obviously aggressive. Assume you go with the technically possible but implausible one patient every 3 weeks and assume the first two patient are both responders and both those responses are fast that's to say they reach partial response status in the 1st and 2nd scans. Then by mid-Aug it was technically possible to hit the 2 confirmed responders, it assumes multiple things are perfect and has very, very low probability but it's not impossible.Let's look at End of year (EoY). If we run with a perfect scenario of 3 weeks per cycle you could get 10+ cycles in from mid-May to EoY. Let's assume Paul is being more realistic with this target. Go with the 1cycle per month assumption underlying the full enrolment date. You have 7 months, so 7 patients enrolled. Probably 5 of those will have had 2 scans. It now seems plausible to get to responders by that date in at least one cancer type. His EoY target is actually the plausible target for the data we want.
But it's worth considering the ultra-cautious approach. They were asked when to expect more data. This is what Christian said.
Unidentified Analyst
Okay. Thank you. And when should we start to expect more data from the basket trial, please?
Christian Marsolais
Well, as we mentioned before, it will depend in terms of the efficacy, but the end of the quarter or next year, within the next six months we should be and we're expecting to have more signs of efficacy that we'll be able to announce.
"Within the next 6 months", that takes us all the way to the end of full enrolment. He's saying this might run to the end. He's got Paul's EoY guess in there as well but Mr Ultra-cautious is saying this could run the full trial before the data is ready for release.
Paul's statements runs from what is plausible but improbable to what's merely plausible. Christian extends that to include a more cautious assessment. Take your pick. I think time is a horrible factor in biotech, CEO's know this so they try to manage it. At the start of a trial they want to suggest it'll get to the end sooner to keep people on board. As those timelines getting missed a bit of realism sets in but you've already done the job of keeping people on board for much of that long time it just becomes an issue of resetting expectations. It happens so often in biotech this can't just be a lesson they are failing to learn, this is the way to do things.
SPCEO1 wrote: I think most TH shareholders thought we would at least get some meaningful comment about developments in the now 5 month old, open label phase 1b. Many, including me, hoped for something more than that as well (one or more of proof of concept, protocol extension, anecdotal encouraging info, FDA discussions info) but recognized that might be asking for too much at this point. I personally have thought that if TH-1902 is what we think it might be and that they have already had 20 or so patients go through the whole 12 week cycle, that we would have some positive news showing up already. My concern was they may not share such news as they may be soring it up to be revealed when market conditions for a share offering are better. Your explanation about how a notable number of those supposed 20 patients under study could take longer than 5 months to reach a point where TH would have something positive to say also is a good explanation for the lack of news even 5 months into the trial. I just wish it was TH making that explanation rather than you. The only thing we got from the conference call in the morning was old news on TH-1902, which is disconcerting, especially in light of the efforts by the company to raise expectations via the "key to unlocking cancer cells" and "a few, several, maybe many" things to report on TH-1902 between mid-August and Christmas" comments (BTW - I went back and checked my notes to get his exact wording on this second quote). The circumstances called for Paul sharing some new piece of info and he did not do so. I will be a bit freaked out until they do share something positive as we are at a critical stage in the development of TH-1902. TH should already know a lot about it's potential for success at t his critical stage and, even if they do not share it with us right away, they should have been building off those quotes above with the content, energy and tone of their comments around TH-1902 during the conference call. They evidently did that in the second call with my friends but I still think we have to a ssume the risks have risen as a result of no new info being revealed on the conference call. I am sure there will be something of note in the poster presentation which will be encouraging but I am more focused on the phase 1b than on pre-clinical work.
qwerty22 wrote: I didn't listen to the call in the morning. Followed the conversation here. Had my expectations totally wrecked by that process. And when I did eventually listen came away thinking it was fine. Do you think maybe your friends listened to the CC expecting something, got nothing, got totally deflated and the phone call could pick them up from there?
I am genuinely looking forward to that poster at the end of the month. It's not going to be the solution to all our problems but it could really nail down some of the discussions we've had here and maybe get some people (no names) to accept that the trial design is the right one.
SPCEO1 wrote: First, all three of my friends had the same disappointed feeling as most everybody else after the 8:30AM conference call. They went into the call with management unhappy. Based on what they told me they did not learn anything new from management - it was more the tone and emphasis around TH-1902 that was completely different. They left that second call feeling that everything was just fine. I think they all came away also thinking that NASH was not totally dead. The 8:30AM call was lacking energyand the later call was not. They asked tough questions and thought they got straightforward answers.
I think you understood me properly about why I chose not to participate. You would have to a sk the company why they don't like me sharing what I hear in those calls here on this website. Humans have a big need to control things, even when it does not make much sense to try or when doing so actually works against your own interests, as it does in this case in my opinion. If they were smart, and they used to be smart, they would try to utilize me to spread the message they want to spread. But that was in a different era when different people were in charge.
jfm1330 wrote: Can you explain to me why your friends can talk with management and come away reassured about TH1902, and me and other little shareholders are left with yesterday's conference call and the same BS? If they have data that would reassure everybody, they should be able to find a way to make it clear to all shareholders. No need to publish the data if they think it's better not do it for now for whatever the reasons, but if they were able to let your friend with a positive feeling, it should have been the same for all of us. Yesterday you wrote that you did not participate because you want to be free to share what you learn in those meetings with big investors. So, again, why the little one are not allowed to know stuff that the big ones can, as long as they don't diclose it publicly. Maybe i did not understand you properly, but that's the way I understood it. Even though they don't disclose insiders info in these meeting, these big investors can come out of these meeting with a better sense of what is going on.
SPCEO1 wrote: Not sure what you are talking about. You were quoting a remark by JFM not me. I am disappointed we have not heard at least one piece of positive info yet from the trial but I am not freaking out. As I noted, other large shareholders I know who met with management yesterday came away feeling very good about the potential of TH-1902 and I they are not idiots. So, if we have had this much patience all ready, I suppose we can summon up just a little more.