RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Another hypotheticalI dont have much doubt that going into a phase b is a certainty but failing to see efficacy in phase 1 a the company will need to promote the program.....What other positive data not related to safety(nor tomor regression) could there be in Phase 1 a ?
Wino115 wrote: I guess the one thing we can say is that not showing efficacy in this 1a, given the reasons you and JFM state, does not mean efficacy is an issue. It may or may not be, and we may or may not know from 1a. But we do know it won't stop doing a 1b and 1b absolutely will have the primary endpoint being RECIST measures in a robust sample of 4 sortilin expressing metastatic tumor types. I don't think the share drops; as to me, there ain't much in there for success at this point and it is a positive step up in the pipeline proving process.
Given they can't ignore discussing it in the earnings call, end Feb should provide incremental news. I wonder given both IR and PR are no longer there is they'll do the analyst email in Q&A. I would hope they keep that going and we can send in questions. Otherwise, they risk the embarrasement of that one quarter when the Cheeto munchers disappeared without a trace. That was the low point in capital market engagement to me.
palinc2000 wrote: Thx Wino .I know that SD is not a meausure of efficacy which in my mind is some form of tumor regression but what we also know us that enrolled patients must have survival exoectations of at least 3 months which means that they still are taking very sick patients with no treatment options.....
R recruitment for Phase 1 part 2 is would probably be facilitated if stable disease was observed .....
Wino115 wrote: My non-scientific view would be only a little, but that's more solid for proof of the concept -- sortilin is a valid target, the peptide attaches, it internalizes, somethings happening. Beyond that it may get harder and you'd need to use that data point with others.
For instance, if it was stable in all the colon cancer targets, well that's pretty remarkable because they showed docetaxol standard care doesn't really do anything in colon cancer. So if you just showed stability, that means it's getting in there where normal chemo does nothing.
I'm good with just seeing solid safety, decent chemo bomb dosage, anything the prove the target and peptide construction. That will help me eliminate the big negative tail around any Phase 1 drug trial. It won't eliminate it all since efficacy will be part 1b, but it will eliminate a bit of it and shift the possible outcome curve a tad more positive on top. The test will be 1b.
palinc2000 wrote: Would stable disease in lets say 25%=-50% of the patients be a sign of efficacy?
qwerty22 wrote: What will be "muddied" at the end of 1a is everything that isn't a goal of this first trial. What (hopefully) won't be "muddied" is everything that is a goal of this trial. I recommend everybody go to the clinicaltrials.gov to see what the goals of this trial are. They are NOT the relationship between Sortilin expression and efficacy, that's wishful thinking on the part of one guy here. The trial is not in any way badly designed because it doesn't match what he hopes to get from the trial. Can it get pK, MTD, RP2D, initial safety and tolerability and maybe first efficacy? Yes. They may have extra details that add to that but those are the goals of this first trial and to me it's designed just right to show those things (especially the primary goals).
palinc2000 wrote: JFM is just trying to cover past posts in which he was dangling a carrot by alluding to possible great results in Phase 1 a ......His posts have covered the whole spectrum of possible results and he will be able to repost by stating his standard opening line.....AS I said many times before!.........
qwerty22 wrote: 1a is just not meant to be optimized for efficacy. Endlessly complaining about that fact is like complaining that the sun comes up in every morning.
jfm1330 wrote: Personally, I will look at what their results will mean for phase Ib. If the results are convincing enough in the sense of a clear proof of concept, with correlation between sortilin overexpression and efficacy, then it will be a no brainer to stay invested because phase Ib with patients selected for sortilin overexpression should amplify the efficacy overall. That being said, on a small sample of all comers, some with sub optimal dose and/or, not many cycles of treatment, results may be hard to interpret clearly. Again, the more I think about it, phase Ia should have been a two arms trial based on sortilin expression. This all comers thing may muddy the waters on such a small number of patients, unless they made some adjustments regarding patient selection after agreement with the FDA. Because all comers is a theoretical thing. As we saw with juniper88's wife, not everybody that want to come in the trial. So there is some selection that is made even though they call it all comers. It's not like give your names we will put them in a hat and do a draw. So this all comers element is not clear, but I guess they agreed with the FDA to have something that will make sense from a scientific point of view.
SPCEO1 wrote: Stocks always trade lower after a big jump higher. Now, depending on the news, it may or may not see a lot of profit-taking. In the end, if the news is really good, annnd, annnd, annnd, etc., then we should see some major players looking to build on the positions they initially started in any share offering and the profit taking might not last all that long or drive the stock much lower. It all depends on how significant the news turns out to be and how well that news is comunciated to investors. I think we have a number of good hints telling us the news will be pretty meaingful, but there is little evidence the company knows how to communicate a good story effectively and there is very solid evidence that TH has no worthwhile research coverage at the moment. We who follow it very closely may find ourselves knowing what TH reports is very significant but then be frustratedd because it never gets the initial 55% jump in the share price you referred to because few people actually were anticipating the news and few ever even heard it.
I am hoping there has been a lot of work behind the scenes to fix those issues but thre is little to no evidence that is the case.
SS1316 wrote: TH seems to always sell off on any positive SP movement, seems as though investors are looking to cash in on their patients even if they're just scalping.
'Hypothetical scenario' if the positive news that we are all imagining for the 1a trial comes through to break TH's deafening scilence annnd the market somehow notices it annnd has a positive response, let's just say a 55% gain over a couple trading days, how quick does it sell off?
Only a hypothetical question, I'm defiantly not over leveraged here.