RE:RE:RE:RE:RE:RE:RE:RE:At least give us news about no news ... There is nothing in the science literature that says this is true, my guess is JFM is leading you down a dead end on this point.
realitycheck4u wrote: I was also questioning how they are going to protect patients who are not expressing Sortilin from getting too much docetaxel. I also would like that clarified.
jfm1330 wrote: I also listen again to the Q&A part of the Q3 CC back in mid-October. To me there is something wrong in this trial design when it comes to determining the MTD, and it is because of the request from FDA to take all comers without testing them in advance for sortilin expression. In the July CC, Marsolais said that from what they saw, only 1% of docetaxel in TH1902 was released free in the bloodstream. I am not sure about that, but one thing I am quite sure of, is that TH1902 will not release the same amount of free docetaxel in the bloodstream in a patient with overexpression of sortilin on his cancer cells, when compared with a patient with no sortilin on his cancer cells. Add to that the variable of tumor burden (the higher the tumor burden, the more cancer cells there are in the body, so they can catch more TH1902, taking it outside the bloodstream before the reslease of free docetaxel in the bloodstream to cause toxicity).
So, in my view, there is really a big potential source of interference when it comes to determining MTD. The MTD will not be the same between a patient that is not expressing sortilin, and one that is expressing it or have high or very high level of overexpression. Then add tumour burden into that equation and you will see a very heterogenous landscape when it comes to determing a single MTD while not taking into account sortilin expression and tumor burden. That is why we need to be careful with the patient that showed some neutropenia. If it was a patient with no sortilin expression or low sortilin expression and a small tumor burden, it can not compare with the reaction of patients with high sortilin expression and/or high tumor burden. If Thera failed in their communication in this whole thing, it's with that aspect of the story. Given the request by the FDA to take all comers without testing in advance for sortilin, this escalation trial is tricky because all patients in it are not equal versus TH1902. Maybe it took longer than expected because they needed to sort that out along the way and needed FDA to agree to allow them to test for sortilin expression on the patient showing neutropenia.
jfm1330 wrote: I listen back to Marsolais in the KOL and July CC. One thing is clear, the whole escalation process ended up being much slower than he stated back then. He talked about one month for every dose increase. So they are way behind schedule on that and we did not get an explaination as to why it has been so much slower than expected. But at the end of the CC in Juky, he clearly said that if the see an initial response, they would need to wait two to three months to confirm the response. Listen again the CC at time 48:40. You will here him say that. So based on that, if they are still not at the MTD now, and treating patient at two or three times MTD of docetaxel alone. It could go to March or April to have validated results on the efficacy front. I guess they would give interim update if it's the case, but based on what he said in July, this is the situation we are in. You won't see full efficacy of TH1902, if there are, after only one cycle. If they see initial efficacy, they need to give more cycles of treatment. Tht's the way cancer treatment works.
https://edge.media-server.com/mmc/p/d9fu3xjc
SPCEO1 wrote: Was MArsolais talking about what they will do in phase 1b to find efficacy? I am under the impression they will not be doing three cycles in phase 1a.
jfm1330 wrote: As always, I am alone on my side when it comes to patience and communication. Marsolais already said that they would need to do two more cycles of treatment to confirm any efficacy sign, that they don't want to publish interim efficacy data based on artefacts. They are very early in this process with TH1902 and they want to come out with solid data, not with impressions. Also, patience is required if you invest in biopharma, It's the nature of the beast, most often than not, it takes longer than expected, for results, submissions of NDA/BLA, approvals or rejections.
SPCEO1 wrote: I suspect you are correct about the window now being closed for the remainder of 2021, unless of course they do something, like sign a partnership deal before year-end as they would have to disclose that. Yesterday the CFO assured me they would announce whatever they can as soon as they can, but on the cancer front at least, it sure seems like it will be January before we hear anything. I don't see why they could not give us an update on where things stand but companies prefer to hold info tight to their vest until they have all of the data and can put the most positive spin on it. If they shared something before all the data was in, they may inadvertently highlight a flaw that they could otherwise hide.
I cannot see how an offering would be done before cancer news is out. If they try that, it will not be an encouraging sign for cancer and the stock would likely tank. The prospects for cancer is what is holding the stock up and if they send a signal that they don't have anything in cancer by doing an offering prior to phase 1a results, the market will assume those results are not good.