I enjoyed this weekend's discussion about the Canadian lady and BO timing and amounts, but the kernel from these posts of most interest to me was CFO Hoffman's comment to the Columbian reporter that " if Leronlimab gains approval" ... CYDY "aims to partner with another pharmaceutical company." The Hoffman quote reminded me of the kernel from the March 5 PR that mentioned "manufacturing readiness" as a potential use for the new Paulson funds, a use that would make no sense if management knows that LL's first approval is still 3 to 5 years in the future.
Granted, the above 2 kernels, sometimes aka bread crumbs, may well be head fakes by CYDY for reasons that are inscrutable to us or perhaps even mindless gibberish. But, even so, the kernels still beg the question of why so many board members have collectively assumed, as reflected in their posts over the last several months, that good/great CRC trial data will relatively quickly generate an acceptable/great BO/partnership offer regardless of whether LL approval is expected to occur in this decade or the next. A byproduct of this reasoning is that BP will be keenly interested in good/great Leronlimab CRC data and will react accordingly, but that the FDA, in wielding its approval powers, will be oblivious to such data.
I categorically agree with the sentiment expressed by several board members that the looming CRC trial data is the single most promising and important iron in the fire for LL and CYDY over the remainder of 2026. I also believe that while good CRC data might generate a reasonable partnership or modest BO offer, data that is only marginally better than the SOC would be very unlikely to inspire any uncommon interest at the FDA. On the other hand, if the CRC tumor shrinkage data were to come in great, as in mind boggling great, I think CYDY would be applying for a Commissioner's voucher asap, and, given the peril of CRC, the FDA would eventually award the voucher, and grant accelerated approval within 2 months thereafter.
I don't have an educated guess as to how long the process of generating data sufficiently mind boggling to shut down the CRC trial and then engaging in the BLA/voucher application/FDA voucher based accelerated approval process would take, but I am curious as to whether CYDY management now actually believe that such a timeline would be brief enough to warrant postponing partnership/BO deals until after LL approval (as Mr Hoffman literally suggested). But, if BO/partnership deals and approval timelines are unrelated phenomena, why would management even consider delaying a BO or partnership? Well, maybe because management has this crazy idea that a BP would pay appreciably more for an already approved drug than the same drug receiving approval 3 to 5 years later (or maybe not at all).
As I hope I've made clear, the premise upon which the very speculative scenario recited above rests is the achievement of great, mind boggling CRC trial data, and the sooner the better. However, not only am I totally deficient in the expertise necessary to offer an educated guess as to the likelihood of great, mind boggling data -- but even if I had such expertise, I have no access to the data in real time. But, it occurs to me that when Mr Hoffman spoke to the reporter a few days ago and mentioned approval before, not after, partnership, he presumably would have had very recent access to the latest trial data. Just saying.
Hopefully, quite a bit of trial data should be made public over the next 2 months or even sooner.
Stay tuned.
Granted, the above 2 kernels, sometimes aka bread crumbs, may well be head fakes by CYDY for reasons that are inscrutable to us or perhaps even mindless gibberish. But, even so, the kernels still beg the question of why so many board members have collectively assumed, as reflected in their posts over the last several months, that good/great CRC trial data will relatively quickly generate an acceptable/great BO/partnership offer regardless of whether LL approval is expected to occur in this decade or the next. A byproduct of this reasoning is that BP will be keenly interested in good/great Leronlimab CRC data and will react accordingly, but that the FDA, in wielding its approval powers, will be oblivious to such data.
I categorically agree with the sentiment expressed by several board members that the looming CRC trial data is the single most promising and important iron in the fire for LL and CYDY over the remainder of 2026. I also believe that while good CRC data might generate a reasonable partnership or modest BO offer, data that is only marginally better than the SOC would be very unlikely to inspire any uncommon interest at the FDA. On the other hand, if the CRC tumor shrinkage data were to come in great, as in mind boggling great, I think CYDY would be applying for a Commissioner's voucher asap, and, given the peril of CRC, the FDA would eventually award the voucher, and grant accelerated approval within 2 months thereafter.
I don't have an educated guess as to how long the process of generating data sufficiently mind boggling to shut down the CRC trial and then engaging in the BLA/voucher application/FDA voucher based accelerated approval process would take, but I am curious as to whether CYDY management now actually believe that such a timeline would be brief enough to warrant postponing partnership/BO deals until after LL approval (as Mr Hoffman literally suggested). But, if BO/partnership deals and approval timelines are unrelated phenomena, why would management even consider delaying a BO or partnership? Well, maybe because management has this crazy idea that a BP would pay appreciably more for an already approved drug than the same drug receiving approval 3 to 5 years later (or maybe not at all).
As I hope I've made clear, the premise upon which the very speculative scenario recited above rests is the achievement of great, mind boggling CRC trial data, and the sooner the better. However, not only am I totally deficient in the expertise necessary to offer an educated guess as to the likelihood of great, mind boggling data -- but even if I had such expertise, I have no access to the data in real time. But, it occurs to me that when Mr Hoffman spoke to the reporter a few days ago and mentioned approval before, not after, partnership, he presumably would have had very recent access to the latest trial data. Just saying.
Hopefully, quite a bit of trial data should be made public over the next 2 months or even sooner.
Stay tuned.
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