RE:RE:RE:Long, very longI am sure TH's management already knows alot more about the situation with the phase 1b trial than we do. That does not mean they are in a position to disclose anything, however. They may have no legal reason they cannot share info with us but there are likely other practical considerations for why they don't just have a Twitter post each day telling us the latest info they have on TH-1902's phase 1b trial progress. There are reasons why no drug companies give shareholders a running tally of wins and losses in their research programs and I suspect it mostly reflects the inability of the financial amrkets to maturely handle such info leading to unnecessary volatility in the share price.
But the absence of info also has a negative cost to it as well. So, I would be in favor of greater and more frequent disclosure. For example, what was the justification for TH withholding info on the three patients who showed signs of efficacy until July? Maybe they did not want many questions asked about that data until they finalized the debt deal as perhaps they thought something about that data could jeapordize the debt deal? Who knows, but it should not have been afactor as the debt deal was focused on the legacy drugs and Marathon is not apparently betting on cancer to get their loan paid back, which is always how such things work.
They did give us hints regarding patient number #2 in the Spring but nothing specific. That patient turned out to be the patient who went 33 weeks on TH-1902,so TH had this information for a long time. Why not share with investors whatever news they had on them when they hit 15 weeks of treatment and then update us every four weeks thereafter about this patient's status on the trial? Does anyone have a theory on why a company, and particularly a company like TH whose stock has been beat up badly due to lack of info, might not think it wise to share some good info like that as it is happening instead of waiting so long to let investors know? It is an open label trial so t here was nothing preventing them from sharing such info as far as I am aware.
Paul seemed pretty confident when he said we will get some data, perhaps a lot of data, between now and Christmas. Surely they can back up that apparent confidence with some info.
In my mind, TH is hoping to have some nice advances in phase 1b that lead to one or more protocol amendments and highlight that the drug has real promise and set it up nicely for a phase 2 registrational trial. I think they are also hoping to have thatdone prior to the full report on the phase 1a trial that is expected in the early part of 2023, perhaps because there might be data in that full report that would raise questions if they already released it, but will then seem less important if the phase 1b trial data has superceded whatever that phase 1a data might include which TH is not ready to share with us.
Maybe there is hope they will change their mind and try to rescue the stock price since they told me what they released in the press release on phase 1a efficacy was all they were going to release but then a little more info came out in the corporate presentation. So, they adjusted and gave us a few more scraps to think about - maybe they will do the same again with phase 1b data.
canadapiet wrote: Ok, respect your view ........and it must be surely a difficult way in "oncology" trials, so many things to take account of.
But other companies are far more "open"(what is IR doing over there????) and trials are going much smoother(mostly because of partnering with a bigger pharma), they are in better financial condition AND .........INSIDERS are far more involved/invested!!!!!
Give me a good reason why they are telling us all those years the shareprice is way to low, no.........RIDICULOUS low, they see "good things" in trials etc, but investing some of their money????????..............HELL NO!!!!!!!
They must know some things by now!!! And it isn't looking like "earth shattering" for that devastating desease, unfortunately....!!!!
Wino115 - (8/23/2022 12:53:29 PM)
RE:Long, very long
CanadaPiet you have to remember what the current standard of care benchmarks are for these refractory and advanced cancer patients. At this point they have tried and exhausted all the current standards used in the hospital. In most of those third and fourth line treatments we have seen that response rates in the 30% level are considered both good and commercial. As for efficacy or progression free survival, it depends on the actual cancer type, but it is anywhere from 6 months of prolonging life to 12 months. In a few of these types, even 4 months would be additive. That is all you need to show in order to be considered as the 4th or 5th line for refractory and become a standard of care. In all likelihood if you hit those benchmarks, you would see oncologists use it earlier.
Many of the blockbuster ADCs hit those 30 to 40% response rates and 6 to 12 months of progression free survival. They also spend a lot of time subsequent in the P2, P3 and later to test different cohort groups to boost those ORR and PFS rates based on baseline criteria. You may recall a post I put up a few weeks back about the newest Trodelvy data and how for HR+ breast, the interim study group only showed a 1.6 month OSS (Tropics2 study). They then added more patients and had much better results than the initial trial cohort and it was because of a particular "screening" they had done (HER2 low and someth8ng called IHC). They haven't released the data but say it met all primary and secondary endpoints, so it showed it expanded the survival rate and months more then the interim readout. The point being, as QWERTY points out, you want to know how your drug responds in all sorts of conditions for the powerful reason that it will help you determine what kinds of patients in what kind of cancer situations your drug has the most chance of success in working and for them to see the full benefits of the therapy and work as it should. Will some doctors try to use it without "hitting" all the characteristics the label is optimized for --of course, because there's so few therapies for these patients. But the patient and doctor know that the fewer of the "optimal" signals are there, the less it may work. But as JFM and others have been saying, cancers and tumors are not homogeneous and each case is almost always unique in some way. No drug label or screening will take into account all the possible permutations. It's all about probabilities and increasing chances. Don't expect perfection, just expect a commercial opportunity to arise if you extend the current SOC slightly.
canadapiet wrote:@SPCEO: my deepest condolences for the loss!
I'm becoming more convinced of the minimal results for now! It takes way to long to recruit patients and the ones we have doesn't seem to benefit that much. They aren't directly targeting those with high sortilin expression, it is all comers, so the trials are more of "a lucky match"....!
Maybe in the long run we will succeed when we can detect the "better patients" and when we can give it "earlier".
The only "thing" that can save us in the near time is some kind of "POC". But how when you can't select the "targeted peatients???