For the many among us who view raised expectations as a recipe for inevitable disappointment, it occurs to me that they can find considerable solace from the Leronlimab CRC related content on this website. For example, they can relieve tension and anxiety by daily rereading a confidently authored post informing us that the promising early data from the CRC trial should bolster hopes that LL, in combination with the current CRC third line SOC drugs, will eventually ( after 12 months of LL infusions followed by a CT scan 8 weeks later and then a few additional months to lock the data for that 60th patient who enrolled last Wednesday) substantially eclipse the 6% ORR level previously set by those 3rd line SOC drugs. And then, according to our knowledgeable board member, CYDY will likely want to wait for 12 month, or perhaps 18 month, OS data to become available in order to drive the final nail in the 3rd line SOC drugs coffin, thereby providing very solid footing to approach the FDA with a Phase 3 protocol to eventually obtain a 3rd line approval for LL to treat CRC. By my reckoning, all of this looks very doable (and with a share price surging well beyond 50 cents and perhaps as high as 1.30) by no later than 2031 or 32. Now, I would hope those expectations are sufficiently modest to meet with approval from even our most conservative board members.
Notwithstanding, however, the undoubtedly pure motives of the trusted source referenced above, and with due regard for his many like minded board supporters, I submit the following sanguine LL scenario in the best tradition of advocating an alternative point of view. for due consideration.
Dr Jay and company have chosen ORR, not OS, as the primary endpoint for the CRC trial. ORR, which relies on CT scans to demonstrate 2 consecutive >30% tumor shrinkages, is the FDA's customary surrogate endpoint for accelerated approval. However, ctDNA blood samples in oncology clinical trials, several of which are taken before the 1st in treatment CT scan, have also been gaining substantial credibility to become a reliable surrogate endpoint for the FDA according to medical articles and journals cited by Google AI. CYDY's AACR poster shows that 14 of 19 patients (74%) with ctDNA reductions between 65 and 100% after only week 2 of treatment. The same AI sources cite a strong correlation between ctDNA reductions >62% and ORR responders. Moreover, the poster also showed that 9 of 13 evaluable patients (69%) had CT scans showing shrinking or stable tumors among these heavily pretreated, refractory patients. These are very preliminary data, but if they improve over the next 3 scan cycles (24 weeks), especially as 700 mg patients come more into play, and that could well happen if the ctDNA blood samples have been fine tuned recently by CreaTV and LL's killer T cell capabilities have been enhanced by AI, the DSMB could recommend halting the trial and proceeding to a Phase 3 confirmatory trial -- all of which could put LL in prime position to receive a Commissioner's voucher for accelerated review of an accelerated approval application.
The rosy scenario above would obviously require not only a running >60% ORR deep into the trial, but also an FDA philosophic approach committed to vastly speeding up the clinical trial/application and review process when the Commissioner focuses on a drug that he believes could save thousands of lives if its approval is prioritized.
To those who would quickly dismiss my scenario as far fetched, I would submit: no more so than the one from our trusted source. It simply depends whether you wish to spend the next several months resigned to low expectations based on a several years of incremental advances or would rather embrace the possibilities that LL may unlock for us and all those desperate patients looking for hope.
Let's see what happens.
Notwithstanding, however, the undoubtedly pure motives of the trusted source referenced above, and with due regard for his many like minded board supporters, I submit the following sanguine LL scenario in the best tradition of advocating an alternative point of view. for due consideration.
Dr Jay and company have chosen ORR, not OS, as the primary endpoint for the CRC trial. ORR, which relies on CT scans to demonstrate 2 consecutive >30% tumor shrinkages, is the FDA's customary surrogate endpoint for accelerated approval. However, ctDNA blood samples in oncology clinical trials, several of which are taken before the 1st in treatment CT scan, have also been gaining substantial credibility to become a reliable surrogate endpoint for the FDA according to medical articles and journals cited by Google AI. CYDY's AACR poster shows that 14 of 19 patients (74%) with ctDNA reductions between 65 and 100% after only week 2 of treatment. The same AI sources cite a strong correlation between ctDNA reductions >62% and ORR responders. Moreover, the poster also showed that 9 of 13 evaluable patients (69%) had CT scans showing shrinking or stable tumors among these heavily pretreated, refractory patients. These are very preliminary data, but if they improve over the next 3 scan cycles (24 weeks), especially as 700 mg patients come more into play, and that could well happen if the ctDNA blood samples have been fine tuned recently by CreaTV and LL's killer T cell capabilities have been enhanced by AI, the DSMB could recommend halting the trial and proceeding to a Phase 3 confirmatory trial -- all of which could put LL in prime position to receive a Commissioner's voucher for accelerated review of an accelerated approval application.
The rosy scenario above would obviously require not only a running >60% ORR deep into the trial, but also an FDA philosophic approach committed to vastly speeding up the clinical trial/application and review process when the Commissioner focuses on a drug that he believes could save thousands of lives if its approval is prioritized.
To those who would quickly dismiss my scenario as far fetched, I would submit: no more so than the one from our trusted source. It simply depends whether you wish to spend the next several months resigned to low expectations based on a several years of incremental advances or would rather embrace the possibilities that LL may unlock for us and all those desperate patients looking for hope.
Let's see what happens.
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