RE:RE:RE:RE:RE:RE:RE:RE:Friday or 4pm NR is betterHe doesn't clearly understand the process so now the company which investors should "trust otherwise sell their position" is misleading investors.Again the slides are not factual and need to be updated but once they are further down the process it's not possible to get an exact date as it will be depending on data so yes the 28 weeks duration should be removed and not replaced by any dates it would be even better if they would explain why. But I believe JFM and some posters still believe the cycles take 3 weeks therefore the trial is behind schedule when in fact each cycle is 6 or 7 weeks as you stated. Not delayed or slow but on time and progressing. Again all of it could be clarified in more details and how the process works by the company and they should provide some explanation so the investors understand instead of guessing or misunderstanding.
qwerty22 wrote: JFM is still peddling something he can't know to be a fact. And there are many reasons to believe it isn't. His folksy understanding of this is leading him up the wrong path. Ask him to actually quantify how much a measurable safety signal is being moved by enrolling all-comers versus targeting just Sortilin expressors. It's impossible to do that, yet he states he knows this to be happening for a fact.
Here's my take. Oct they successfully got through the slow safety crawl to the doses that matter. The public statement was to mark that moment. What is the point of the present section of the trial? I would say to define the therapeutic window (if there is going to be one). So formally you don't reach that point until you've defined your MTD or decided on your RP2D. That requires the still slow crawl through enrolled patients and escalating doses and it needs the accumulation of all the safety (and efficacy) data. What you want is not that. What you want them to do is throw a bone to the long suffering investors and tell us if they have the first sniff of efficacy. I think all they can formally promise is to deliver what the trial is designed to deliver which at this stage is the MTD and likely all the data is not in for that. They can't promise us "the bone" until it arrives and even then I guess there are decisions to make on when to throw it. As painful as it is I think if you let yourself add 3-6 months to the timeline, if you think that a drug cycle takes 3 weeks but maybe escalation to the next dose actually takes 6-7 weeks, then I think it's all explained. MTD is probably due maybe around the anniversary of the start of the trial. If they have any clear confirmed efficacy signa they might report that before hand. Officially we are waiting for MTD, maybe there is still some uncertainty about when that comes but hopefully Springtime and hopefully if that uncertainty diminishes then they can be more clear about that.
Clinically they are doing the right thing by waiting for the MTD to be reached, maybe that doesn't satisfy things on the investment side of things.
SPCEO1 wrote: Also, it does not seem like it would be that hard or disruptive to what TH is doing to just tell us what is actually going on with the trial. What might prevent them from doing that?
jfm1330 wrote: They misled us by not correcting their previous statements. Marsolais clearly said that a cycle was one month, three weeks of treatment plus time to make sure everything is fine. They are way behind their own timeline. Back in June theyr were expecting results somewhere in Q4. Then it was, maybe begining of February, and now we have no clues, Also, back on November 11, Levesque said this:
But the strange thing in the Credit Suisse presentation, is that Levesque says that they had "many patients", or "at least several patients" that have been dosed over 300 mg/m2 (300 mg/m2 is step 5 of the escalation process). So over 300 mg/m2 is 420 mg/m2. So back in November he said that they had "many, or at least several patients" that have been dosed above 300 mg/m2, so at 420 mg/m2. So probably, back then, the three added patients at step 6, which, again, is 420 mg/m2, were already injected. This presentation was held on November 11. So by now, the 420 mg/m2 should have been completed and cleared. Without any news at this point, it is likely that they are now at step 7, which is 560 mg/m2 or 2.43 times the MTD of docetaxel alone. Now, a full two months later, they put in the corporate presentation that they are testing at 420 mg/m2, So two months ago they had "many patients' or "at least several patients" dosed above 300 mg/m2, so at 420 mg/m2. And two months later they are at the same point. What does that mean? To me either what Levesque said on November 11 was false, or they are awfully slow, or they tested a higher dose and are now back to 420 mg/m2 to confirm it as the MTD.
But again, this "all comers" thing is problematic to determine the MTD. The MTD will not be the same on patients without tumors overexpressing sortilin or with a very small tumor, and a patient with a large tumor burden overexpressing sortilin. So maybe it led to problems in the trial that they had to fix with the FDA.
jfm1330 wrote: Open label refers only to the fact that both patient and doctor knows that the drug is given. This has no impact on confidentiality related issues. Those with access to results data knowing to what drug it relates are under confidentiality agreements. For all we can be frustrated about with Thera, they are not a leaky company. The slide in the SP is not related to selling by people aware of the results. It's related to the speculative nature of the stock and to the long waiting time. Last year they published Q4 results on February 11. So in theory we are three weeks away from some update.
SPCEO1 wrote: I remember some time back, probably two years or so, Dubuc telling me that cancer trials were open label and therefore they would be able to share results as they see them.
The question for us now is what did they see in October that made them switch to a "no more info on the trial until MTD is reached".
If you are an optimist, you convince yourself they saw some tumor regression and decided to husband the good info for release at a time TH considers optimal (likely just before a fundraising).
If you are a pessimist, you conclude TH already knows TH-1902 has issues and is not sharing anything about it now hoping they can come up with some offsetting good info in the meantime.
Then you need to take into account other info. Dr. Rothenberg joining up. Options granted early and heavily. SN-38 being looked into. I don't think Rothenberg joins up unless they had seen something positive. The options situation still hints at something going on. SN-38 might mean there is an issue with TH-1902 and they believe SN-38 will solve it or that TH-1902 is going great with a safer option for a phase 1 and things could go even betterr with a drug like SN-38.
Wino115 wrote: Question for the board on what the term "open label" means for this Phase 1. If I recall, this has been described as open label. I'm very unclear about what that means. Google just says it means the patient and doctor know what they are getting, so seems more apt for a placebo controlled study.
The reason I bring this up is that if open label means all the data is collected and viewable by other clinicians, CMO, CEO, etc... they would then run the risk of someone "inside" seeing things like scans or responses and trading on that info. Someone on the other board mentioned this situation and felt the declining stock price suggested no efficacy or response seen yet.
Anyone understand the actual intracacies of what open lable means for this trial? If it's as he suggests, then a company absolutely should inform the market of anything material.
SPCEO1 wrote: The first meeting is a breakfast on Monday. So, if TH wants to talk about somethnig other than is in the presentation, they would need to do a press release today or Monday morning before the open. I would be shocked if either happened, so for the moment at least, what is in the presentation is all that we are going to get from the company after a long period of silence. The people meeting with the executive team (CMO, CFO and CEO will be in attendance) will be able to read body language, ,attitudes, etc. and come away with a perception of where things are at but they will not have any hard facts to chew on. The main reason for that is the phase 1a trial is not completed and, for reasons that have yet to be explained, TH has chosen to not share trial info until the MTD is found.
Since I do not think the CMO, CFO and CMO have been on vacation the last few months, we can be sure a lot has happened behind the scenes. The average TH investor, an incredibly patient person, is more than ready to hear what is really going on and it seems like we will have to wait even longer to get the info that is needed to accurately determine the propsects for this investment. The weight of evidence we have at the moment suggests something good is the most likely outcome but we don't know how good and we don't have a firm grasp of the odds of some degree of success. Hopefully, it will not take too much longer for TH to de-risk this situation.
realitycheck4u wrote: As I had stated before. If some news is coming out then it shoulod be released at 4pm as this gives time for news to circulate in advance of a call for the next morning. It ensures good news is digested.