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Posted On: 09/27/2025 5:37:42 AM
Post# of 157405
At the risk of being accused of cruelty to dead horses, I want to say why I believe the protocol of the CRC trial should be changed if it is humanly possible. Right now no one will receive an ICI in conjunction with Leron until a year after treatment begins (or so I believe). Here are my reasons for asking the protocol to be changed.
1) People might die in that year. It's an aggressive cancer, and even with the benefit of Leron shrinking tumors and mostly eliminating traveling cancer cells, some patients will probably die in the year before getting an ICI.
2) People might die even after that year. I don't think we know for sure how long PD-L1s, elevated by Leron, REMAIN elevated. It might be that nearly a year after PD-L1s are more fully expressed, the count drops again.\ (I'd be glad to be corrected here.)
3) What reason is there NOT to give ICIs in the main trial? Several people have said a good reason to exclude ICIs is this idea: if a trial with Leron + an ICI succeeds, no one will know whether it was Leron or the ICI that was responsible. That is total blather. ICIs are not part of the SOC for mssCRC because we know they do NOT succeed on their own. They have not been shown to be beneficial at all. So the FDA and ICI makers alike will know that any success is down to Leron, even if ICIs are included.
4) The FDA may be intractable. Dr. Jay has run across this before, with CD12, when the FDA (and I think Nader) insisted on running a trial with a flawed protocol. Jay has since said that not insisting on a better protocol was one of the greatest regrets in his life. Many thousands of people died from Covid because of that mistake. The same thing could happen here. The results of this CRC trial without an ICI in the first year might not be so strong that Leron zooms to approval. Again many may die. And the company might be back in the wilderness. We need to insist with everything we have, including gathering testimonials from KOLS.
5) Is this the last bite of the apple? We do not have many chances left, surely. We have to get this one right. People's lives are on the line, and our company probably is too.
1) People might die in that year. It's an aggressive cancer, and even with the benefit of Leron shrinking tumors and mostly eliminating traveling cancer cells, some patients will probably die in the year before getting an ICI.
2) People might die even after that year. I don't think we know for sure how long PD-L1s, elevated by Leron, REMAIN elevated. It might be that nearly a year after PD-L1s are more fully expressed, the count drops again.\ (I'd be glad to be corrected here.)
3) What reason is there NOT to give ICIs in the main trial? Several people have said a good reason to exclude ICIs is this idea: if a trial with Leron + an ICI succeeds, no one will know whether it was Leron or the ICI that was responsible. That is total blather. ICIs are not part of the SOC for mssCRC because we know they do NOT succeed on their own. They have not been shown to be beneficial at all. So the FDA and ICI makers alike will know that any success is down to Leron, even if ICIs are included.
4) The FDA may be intractable. Dr. Jay has run across this before, with CD12, when the FDA (and I think Nader) insisted on running a trial with a flawed protocol. Jay has since said that not insisting on a better protocol was one of the greatest regrets in his life. Many thousands of people died from Covid because of that mistake. The same thing could happen here. The results of this CRC trial without an ICI in the first year might not be so strong that Leron zooms to approval. Again many may die. And the company might be back in the wilderness. We need to insist with everything we have, including gathering testimonials from KOLS.
5) Is this the last bite of the apple? We do not have many chances left, surely. We have to get this one right. People's lives are on the line, and our company probably is too.
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