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Posted On: 07/06/2025 10:18:36 PM
Post# of 155057
Based on logic and common sense, the stunning Leronlimab/ICI survival data announced in Munich would herald the imminent launch of a mTNBC Phase 3 clinical trial combining an ICI with LL when LL turned cold tumors hot. In such a trial, meeting an OS primary end point well beyond the reach of Trodelvy would not only virtually guarantee approval, it would throw wide open the door to the huge cold tumor cancer market.
Of course, CYDY lacks the funds to conduct such a trial without the upfront payment from a partnership agreement, preferably with one of the small group of ICI owners, the most prominent of which is Merck/Keytruda. In light of these circumstances, what possible better time to announce the formation of such a partnership than on Monday or Tuesday of this week with CYDY's Dr Richard Pestell delivering a 20 minute video taped speech this Tuesday on Leronlimab's mTNBC survival results to the entire assembly at the World Congress on Cancer Research and Therapy meeting in Vienna.
Unfortunately, however, applying logic and common sense to the need for partnership funding of this no brainer clinical trial will not be a simple task. In addition to an upfront payment, I would guess that such an agreement would need to include several outcome driven milestone payments and a myriad of other potentially contentious provisions and issues. While I have little doubt that CYDY's board of directors and Dr Jay would be extremely pleased to announce an oncology partnership agreement, especially in concert with Dr Pestell's Vienna presentation, their fiduciary duties require that they first determine that the terms and provisions of any such agreement would be fair and reasonable to CYDY's shareholders. The ICI owner's management would be bound by the same constraints relative to its shareholders. And given the enormous potential oncology revenues that Leronlimab might, but may not, generate, agreeing on the payment terms will be a daunting negotiating. challenge for both parties.
Notwithstanding the heretofore mentioned logic and common sense permeating the current LL TNBC landscape, the extended silence from CYDY gives us no idea whether any serious partnership negotiations are occurring (except through tea leaf reading). If they are, any potential agreement could still be many weeks away for the reasons mentioned above. But since it would also definitely be in the best interests of both parties to reach a deal as soon as possible, I'm still going to check for a PR on Monday and Tuesday morning with a bit more sense of anticipation than normal.
Of course, CYDY lacks the funds to conduct such a trial without the upfront payment from a partnership agreement, preferably with one of the small group of ICI owners, the most prominent of which is Merck/Keytruda. In light of these circumstances, what possible better time to announce the formation of such a partnership than on Monday or Tuesday of this week with CYDY's Dr Richard Pestell delivering a 20 minute video taped speech this Tuesday on Leronlimab's mTNBC survival results to the entire assembly at the World Congress on Cancer Research and Therapy meeting in Vienna.
Unfortunately, however, applying logic and common sense to the need for partnership funding of this no brainer clinical trial will not be a simple task. In addition to an upfront payment, I would guess that such an agreement would need to include several outcome driven milestone payments and a myriad of other potentially contentious provisions and issues. While I have little doubt that CYDY's board of directors and Dr Jay would be extremely pleased to announce an oncology partnership agreement, especially in concert with Dr Pestell's Vienna presentation, their fiduciary duties require that they first determine that the terms and provisions of any such agreement would be fair and reasonable to CYDY's shareholders. The ICI owner's management would be bound by the same constraints relative to its shareholders. And given the enormous potential oncology revenues that Leronlimab might, but may not, generate, agreeing on the payment terms will be a daunting negotiating. challenge for both parties.
Notwithstanding the heretofore mentioned logic and common sense permeating the current LL TNBC landscape, the extended silence from CYDY gives us no idea whether any serious partnership negotiations are occurring (except through tea leaf reading). If they are, any potential agreement could still be many weeks away for the reasons mentioned above. But since it would also definitely be in the best interests of both parties to reach a deal as soon as possible, I'm still going to check for a PR on Monday and Tuesday morning with a bit more sense of anticipation than normal.
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