SPCEO1 wrote: Investors always have to sort through the info any company shares to try to ferret out something that is closer to the truth, the whole truth and nothing but the truth than the "truth" that management carefully curates to create a favorable narrative. It is just a fact of life and it is why this board has been so valuable - there are some really good insights shared by many here. But it is unavidable that the company's words will shape our perspective more than anything else and management knows they have that advantage over us and use it, sometimes indiscriminately. While management's are subject to regulations and do face the threat of lawsuits for misleading investors, it is really not something that typically constrains them too much. For example, the claim TH made that the legacy drug sales were going to grow at 20-25% just before launching the ONO only to see the very next quarter's sales greatly disappoint is as clear an indicator of TH's management's willingness to strategically mislead investors. So, they have demonstrated they will even stoop to ridiculous lies like that to achieve a desired goal. Based on that and other lies they have told is why I have not bothered to speak with TH's management since the announcement of the ONO. If they are going to mislead, what is the point of speaking to them? If instead you rely on just their public comments, then you are probably getting a somewhat more accurate understanding of what is actually going on since the constraints of securities regulations likely reduces the amount of deception they might be willing to engage in. But you can be sure that when their lips are moving they are still not telling the truth, the whole truth and nothing but the truth.
I have offered one reasonable explanation for why this might be so right now - the prospect of another share offering on the near term horizon. The raising of new capital is such a critical element in the life of a small company that virtually all decsions about what to share with investors revolve around that. So when a cash raise is nearby, management works especially hard to curate the info they are willing to share with investors to create the optimum narrative to support the offering. Since these are critical events in the life of small companies, we should not necessarily view this effort to bend the truth to fit a more positive scenario as evil management trying to con shareholders but as realistic management looking to obtain the best terms in a negotiation over the amount of and the price of the shares sold, something which in the end will be a good thing for all shareholders. So, over time, investors have learned that this is the way the game is played and tolerate it.
So, add me to the list of those who are concerned about the reluctance to share information about the open label phase 1a trial. I am hoping they are simply curating about the trial info so that it has the greatest impact when they share it prior to the next fund raising. But it is also possible that if we knew all the data, there might be some ugly aspects in there as well. It is rare that any drug trial only returns good results so we should logically assume they are not sharing some less hopeful data coming out of the phase 1a. And we should logically assume this all the more so because of the unwillingness to share much info about the trial and because of their proven track record to bend the truth.
But that does not mean that TH-1902 will not be a success. It just means the final results will undoubtedly have a little more hair on them than we currently conceive. Those rough spots on the results will likely raise some questions that will need to be answered in future testing, which is why the FDA has companies go through all these rounds of tests before approving a drug - to shave the hair off of them as much as possible. TH-1902 does not seem to be as risky drug a drug as most, but there still will almost certainly be some issues the drug will need to contend with - that is the norm. TH slipped up by even mentioning the rat toxicology tests that we know nothing about but there are likely other tests they have never mentioned which might raise some additional doubts in our mind if we both knew those tests existed and what the results were.
In the end, we will know all the results but those will likely not be revealed until after the fund raising. Now, if the results are all positive, then we will likely know them before the offering. And, for all we know, the results may be all positive. Even TH likely does not yet know if the results of the pahse 1a will be all positive and therefore, they are keeping quiet until they have all the info, which makes sense. They don't want to say something positive mid-test only to have to backtrack later when more data commes in.
Still, the changing patient protocol slide is a good reminder that the company has been fine allowing us to believe something for an extended period of time that has not actually been happening. They have already been active in creating a positive narrative for us around the phase 1a's progress and are just now bringing us up to speed on the reality of the progress of the 1a. It is distasteful but it is the reality in the world of biotech that investors are not typically given the truth, the whole truth and nothing but the truth during key drug trials.
So, while I am disturbed by such behavior, particularly when the CEO is spouting superlative after superlative about the trial, it is part of the game. We on this board are doing our best to dig through the limited info we have to discover the truth and I am constantly amazed at how well we do that. I really appreciate the efforts of JFM and Qwerty, among others, to point out important points on the medical side of the equation that I do not have the skill set to see or understand on my own.
Despite the lack of information being shared on the phase 1a, I believe the appointment of Dr. Rothenberg to be a very big signal to investors that there is something big going on with the Srot1+ program. His showing up on the scene tells me a lot and really does offset the lack of data and shifting onfo in the patient protocol slide. It may be that TH-1902 will be a total flop but that Pfizer will step in and partner with TH on a siRNA approach using the Sort1+ technology. Maybe Pfizer would even buy a stake in TH as part of that process to solidify their hold on this potentially game-changing technology. It is entirely possible that all our focus on TH-1902's phase 1a trial may quickly become entirely irrelevant to the TH story as something much bigger and more important takes center stage.
Another indicator will be what Soleus did with their shareholdings during the third quarter, which we will know more about by next Tuesday. You can be sure that the medical experts on staff at Soleus are in very close communication with TH and likely are aware of much more info than we are. I am not suggesting they are receiving insider info but, due to their skill level, they likely can read a lot more into the "soft info" they are getting in their discussions with management than we can. If they are sellers, than we may have reason to be concerned (although you would need to view that in the context of what is happening at their firm - if they are losing accounts they may have been selling when they did not want to). If they are buying, then we can all feel a bit better about the phase 1a and/or what may lie beyond it.
Finally, if there is significant bad data that TH is currently hiding from us, then they are exceptionally bold liars. And I don't think they are normally exceptionally bold liars. Occaisionally, they are, and that has to be admitted, but I don't think it is a habitul thing. The way Paul has described the phase 1a so far seems to me to be largely genuine. He is not a crazy person and I really doubt he would use the superlatives he has been using if he knew he was going to be enormously embarrassed late when the truth came out. He should already be aware that the lies told around the ONO almost cost him and the board their jobs. He is not a fool. So, while we will undoubtedly find that TH-1902 has some haor on it, I really cannot see it being something distrous to the program.
qwerty22 wrote: I have a very low expectation that biotech execs tell investor the WHOLE truth and the less palatable stuff only comes out when forced. I can't put everything together that's been said in the past and now a make it work without some bending of the truth. I could lay out a few scenarios but they all have a deal of cynicism in them. It could be that the FDA has signalled all along slow progress and so the earlier indications of thing progressing faster just ignored that fact. I don't necessarily think things always take long. I think biotech guys just don't like to lay down the bare truth at the start of something that has a long timeline, they give us the absolute best possible scenario, which was never the likeliest outcome, and then deal with the adjustments as things come along.
When you look at that protocol if we are only at patient 7 then the bulk of part 1 patients are still ahead of us. That would suggest this bleed well into Q1 22. We are probably at the point where you might have expected the first sign of efficacy. It might still happen soon. So maybe they thought they could have delivered the news they really need by end of year and it wouldn't matter so much they were still recruiting in part 1.
I think given the sparse data they've shared nothing look obviously negative. If they want a more positive reading of the cancer program they are going to need to disclose more.
SPCEO1 wrote: Sorry for the tests - just trying to sort out the copying an image issue using the technique wino suggested.
So, since the first patient died, let's assume the others have lived just for argument's sake. Since we know we have advanced to the 420 level, does that mean that only one patient has recieved drug at the 300 level or did all of the 4 assumed remaining patients advance to the 300 level? If only one patient got a dosage at the 300 level, is that good enough for the FDA? I would think they would want multiple patients to have shown no toxicity at that level before establishing it as the MTD.
Why did TH use the rpevious slides of this variety that were clearly not what was going on? And how could it take this long to dose just 6 patients overall? Should we be concerned about the seemingly very slow pace of the trial? I am continuously amazed at how drug companies always massively underestimate the time period for a trial to be completed.
Do they have to get to at least 15 patients for the trial to end?