I wouldn't say these are all issues for now. An issue would be if CLTX CAR-T certainly cause cerebral edema not whether it could be a possible cause of cerebral edema, because the doctors aren't entirely sure. One thing that needs to be clear upin the abstract is the definition of serious adverse event (SAE). The abstract labelled cerebral edema as a serious adverse event, which is important because SAE's are reported regardless of their causality to the therapy (the patient could have cerebral edema from another cause, but it would still need to be reported and probably would be in this abstract). Additionally, when an investigator (doctor overseeing the trial) does report an SAE they have to give a causality assessment ranging from unlikely, possible, probable, and certain. This is listed as possible and it's most likely because GBM also causes cerebral edema and it is difficult both medically and ethically to determine the exact causality of this event. I would be more worried if this was listed as probable and certain as that would be a lot closer to an issue rather than a question or query.
With that said, cerebral edema in a patient during a trial is a big thing. It was a big thing for the other approved CAR-T Cell Therapy's and naturally, it will have an effect on the share price as we have seen - so I'm with you on that. I would be worried if I was expecting a huge pump in price and need to pull out of my investment in the next 2 months, but if you have a long term view, you just gotta be patient.
Information regarding the pharmacodynamics in this trial will result in protocol changes in any pivotal/registrational trial after this trial, which will allow for that trial to be more successful. Additionally, if they do find any correlation with other protein markers in this first few cohort's that relate to efficacy with CLTX CAR-T, this could actually lead to a protocol amendment which allows for the recruitment of subjects with those protein markers and it could also lead for the targeting of other tumours that express those protein markers, hence, the planned basket trial for CLTX CAR-T
The questions you posted here are all valid questions, which needs to be answered. They relate to the purpose of the trial which is to understand pharmacokinetics (how the drug travels around the body), pharmacodynamics (how the drug works with it's target - mechanism of action), safety profile, and efficacy readings. All of your questions needs to be answered by the entire phase 1 trial, and we've gotten some answers to those questions in the first cohort so yes still a long way to go.
I would assume a lot of people have put you on ignore on this thread, but I haven't because I do see the value in your questions (just please don't attack people). I actually use it to challenge my own understanding and research and to see if I'm actually missing something from my research. So far your questions and issues are answerable by the research that I've done on academic papers. Actually, the more I research, the more I accidentally stumble upon information out about the whole scope of this therapy and trial. But keep raising your issues and queries, I'm sure there are more as the readouts come and you'll probably have more.
I'm going to keep answering your questions for the rest of this thread because it is informational and it'll be useful for people to understand and see the larger context of these report. It's not a waste of time for me, it's actually beneficial.
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