ScoreCarder, I read your post, and despite the shots taken at me, I actually agree with the core of your premise.
You are absolutely right: the MSS-CRC trial data is the ultimate arbiter. If Leronlimab does not show tumor shrinkage on those 8 and 12-week scans, and if it fails to upregulate PD-L1 (or PD-1 expression, as you noted) by a significant multiple, then the thesis breaks. The clinical data is the engine, and without it, the car doesn’t move. We are 100% on the same page regarding the gravity of this specific trial.
Where our perspectives diverge is not on the importance of the data, but on the importance of the environment which that data is about to enter.
You prefer to focus entirely on the creation of the data. That is a valid, zero-distraction approach. My posts, which you view as aimless ramblings, are focused on the Clinical Physics and the Financial Physics which dictate how Big Pharma and the FDA react to that data once it exists.
Here is why that macro-level analysis matters to many on these boards, even if it doesn't matter to you:
1. The Weight of the Data has Changed: A 30-patient trial readout in 2026 carries fundamentally different structural weight than a 30-patient trial did in 2019. Because of the recent FDA shifts (like Project Pragmatica) moving away from the Two-Trial Dogma, Big Pharma doesn't need to see a massive 500-patient Phase 3 trial to initiate a buyout. If CytoDyn proves the unmasking (PD-L1) and the tumor shrinkage in this lean, 30-to-40 patient cohort, the accelerated approval math kicks because it becomes a possibility. Yes, if LL upregulates PD-L1, it provides Merck a shot to Evergreen their Keytruda franchise. I would expect you to see that though it is based on Contingencies. Understanding the FDA regulatory shifts keeps investors from misjudging the finish line.
2. The Competitive Urgency: You mentioned that timelines and competitor environments aren't worth discussing. But if Merck is staring down a $30B patent cliff in 2028, their urgency to acquire a cold to hot conversion asset (like Leronlimab) directly impacts the premium they are willing to pay today. Their urgency is immediate. Tracking it helps me to know what is reasonable to expect.
3. I Align with you on the Readout Window:
For what it's worth, your math on the April/May readout is highly logical. If they had 30 enrolled by the end of January, pulling 8-week scans by late March and 12-week scans by late April aligns with the AACR window. Like you, I would love to see the 700mg cohort fully baked into that readout to show the definitive dose-dependent response.
My analysis isn’t meant to convince anyone to ignore the MSS-CRC scans. It is meant to prepare myself & anyone who wishes to read for whatever may follow. Possibly even if the pharmaceutical industry might weaponize those scans the moment they are published. I want to be ready.
We are both watching the exact same 8 and 12-week scans, ScoreCarder. What I do with that information is assemble it so I can understand it. Let’s see what April brings.
You are absolutely right: the MSS-CRC trial data is the ultimate arbiter. If Leronlimab does not show tumor shrinkage on those 8 and 12-week scans, and if it fails to upregulate PD-L1 (or PD-1 expression, as you noted) by a significant multiple, then the thesis breaks. The clinical data is the engine, and without it, the car doesn’t move. We are 100% on the same page regarding the gravity of this specific trial.
Where our perspectives diverge is not on the importance of the data, but on the importance of the environment which that data is about to enter.
You prefer to focus entirely on the creation of the data. That is a valid, zero-distraction approach. My posts, which you view as aimless ramblings, are focused on the Clinical Physics and the Financial Physics which dictate how Big Pharma and the FDA react to that data once it exists.
Here is why that macro-level analysis matters to many on these boards, even if it doesn't matter to you:
1. The Weight of the Data has Changed: A 30-patient trial readout in 2026 carries fundamentally different structural weight than a 30-patient trial did in 2019. Because of the recent FDA shifts (like Project Pragmatica) moving away from the Two-Trial Dogma, Big Pharma doesn't need to see a massive 500-patient Phase 3 trial to initiate a buyout. If CytoDyn proves the unmasking (PD-L1) and the tumor shrinkage in this lean, 30-to-40 patient cohort, the accelerated approval math kicks because it becomes a possibility. Yes, if LL upregulates PD-L1, it provides Merck a shot to Evergreen their Keytruda franchise. I would expect you to see that though it is based on Contingencies. Understanding the FDA regulatory shifts keeps investors from misjudging the finish line.
2. The Competitive Urgency: You mentioned that timelines and competitor environments aren't worth discussing. But if Merck is staring down a $30B patent cliff in 2028, their urgency to acquire a cold to hot conversion asset (like Leronlimab) directly impacts the premium they are willing to pay today. Their urgency is immediate. Tracking it helps me to know what is reasonable to expect.
3. I Align with you on the Readout Window:
For what it's worth, your math on the April/May readout is highly logical. If they had 30 enrolled by the end of January, pulling 8-week scans by late March and 12-week scans by late April aligns with the AACR window. Like you, I would love to see the 700mg cohort fully baked into that readout to show the definitive dose-dependent response.
My analysis isn’t meant to convince anyone to ignore the MSS-CRC scans. It is meant to prepare myself & anyone who wishes to read for whatever may follow. Possibly even if the pharmaceutical industry might weaponize those scans the moment they are published. I want to be ready.
We are both watching the exact same 8 and 12-week scans, ScoreCarder. What I do with that information is assemble it so I can understand it. Let’s see what April brings.
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