RE:RE:RE:RE:RE:RE:RE:RE:Fireside Chat on August 10Well, other don't have access to it unless they also know my cousin and she shares info with them and they are investors. So, I think it is reasonable to conclude that I will have access that others do not have. Now, I also think it is reasonable to conclude that, assuming I did get some interesting info as a result of her being on the trial, that it would not be material. I mean, I would not alter my investment in TH in any way on the basis of data from just one patient. It might be interesting info but in a 70 patient trial, it doesn't mean much of anything that you should invest of off. You really need all the data to draw any reasonable conclusion (and even then it is often difficult!).
That being said, there are these folks called regulators and it is reasonable to want to stay as far from what they might consider material non-public info as possible. These are judgement calls in many cases and you never know when a regulator might have rolled out of the wrong side of bed that morning. So, if my cousin does enter the trial and I do come into some info that might in any way be interpreted by some regulator as material info, I will be shutting things down here until the info becomes public. It is better to be safe than sorry. I cannot see how there is any chance of me getting anything that might seem like material non-public info to some regulator out there until late September at the earliest when she would be due for her six week scan if she actually does go ahead with entering the trial.
It is also worth noting that getting basic info from her about her current situation as I try to help her make the decision as to whether to enter the trial is like pulling teeth. She is both somewhat secretive about everything in her life and also apparently not very inquisitive about her own cancer situation either. Additionally, while my wife and I have taken her to her two appointments so far, my sister may take over some or all of those duties, further limiting my access to info. So, the chances are not very great that I will obtain any noteworthy info in the first place. But if I even come close to doing so, I will be taking an overly conservative approach to how I react to that.
PWIB123 wrote: I appreciate your desire to be without reproach, but I wouldn't have thought access to information from a public source that other participants have access to would be considered insider information.
SPCEO1 wrote: On a related note, if she does go forward with the TH-1902 trial, it is possible I will at some point come in contact with info that is material non-public info on TH-1902. I am guessing that chance is low until at least her six week scan and maybe beyond. Moreover, any updates I get from her would be anecdotal at best and would not be something I or anyone else should use to buy or sell the stock. But given the sensitivity of such matters, I will likely shut down my commentary here, either in regard to TH-1902 or maybe even totally, if I think I have anything that anyone might believe is material non-public info, even if I don't think it is. I will let you know if this becomes an issue but I suspect it will not until late September, if at all. And I do not know if she will join the trial in the end anyway yet though she seems to be keen to do so at the moment. Her oncologist might talk her out of it though and I am wondering myself if it is the best option for her situation.
jfm1330 wrote: Christian said on the CC that they did not see any neuropathy at 300 mg/m2 so far. But I will state once again that toxicity is related to tumor burden and sortilin expression level on tumors. If you have a small tumor, or tumors at the low end of the spectrum for what is called sortilin overexpression, or a combination of both, then there will be much more TH1902 available to enter other cells expressing sortilin, or for TH1902 to be degraded in the bloodstream and free docetaxel released. Just as a reminder, free docetaxel can enter any cell, including, obviously, healthy cells.
I gave the reference many time, but the fact that the percentage of the injected PDC ending up in the tumor is related to tumor burden and level of receptor expression is proven for Dotatate. Other factors are at play, in the case of Lu177-Dotatate the product is eliminated throug the kidneys, so the efficacy of the renal function is critical. In the case of TH1902, the elimination of docetaxel is through the liver, in the bile and the feces. So a patient with hepatic problems will eliminate docetaxel at a slower rate, hence, more toxicity elsewhere in the body.
So there are many factors that can play a role in toxicity. The dose Thera is giving is not adjusted for cancer sortilin burden (total tumor burden x sortilin expression level), it is adjusted for body size (surface area in m2). So they use a targeted drug without confirmation of the cancer related target presence and quantity. So there is no surprise in the fact that toxicity will vary from patient to patient. Remember, we have no confirmation that they have bipsies confirming sortilin overexpression. At this point this is the glaring hole in their scientific communication. It makes no sense to report on a targeted drug with no confirmation of the target presence on tumors or the amount sortilin on tumors.
SPCEO1 wrote: All good points to consider but what do you think about the patient who went for 33 weeks and only came off the trial because they wanted to return to "normal life"?