Sjacobs--Appreciate the clarity on the meaning of "Tier 2 FDA authorization," I clearly got that wrong. As you point out, any kind of accelerated approval for diagnostics goes through the FDAs "Breakthrough Devices Program." Good to have that on the radar to track any further developments. And I really enjoyed your back-and-forth with ScoreCarder, and Brentie's addition of the article on Natera's aspirations in oncology diagnostics. I share your hope and enthusiasm that the Signatera test documenting ctDNA declines may serve as a "validated surrogate endpoint to support AA or BTD" for leronlimab. Looks like the pieces are falling into place--with uncommon speed for these kind of things--for what is likely to be a revolution in cancer care. And your comments on an early partnership with upfront money--to keep the lights on and validate Cytodyn as a player in oncology--but waiting on any buyout or bigger deal for more mature results... That is spot on. You are preaching to the choir on that one!
From a patient perspective, I think Creatv's test is also really crucial. The Signatera test tells you if your drugs are working... which is to say it is backward-looking. Of course that is crucial information, and if it can tell you that information in a couple weeks as noted in the Clover trial, well, that is virtually real-time compared to waiting for RECIST criteria: a couple of scans, 8 weeks apart. But LifeTracDx is going to tell the docs if you are eligible for an ICI, which is real-time, actionable information. Take the test, and if you meet the threshold, you get an ICI tomorrow. So if you are a patient, what would be more significant: Knowing your current drugs are working by ctDNA reduction (Natera), or knowing that your PD-L1 numbers hit the magic mark and you are immediately eligible for an ICI that will finish the job, and do it pretty quickly (Creatv)?
I agree that the Natera connection is huge. And their data-bank--something like 2 million records of the molecular dynamics of CRC patients and how they react to various drugs--won't that sort of serve as a virtual control-group for later studies? Unleash AI on that data-base, and compare it to the couple-hundred people that have taken leronlimab for cancer... That alone is probably worth whatever Cytodyn is paying them. But to an individual cancer patient--and their families and loved ones--those PD-L1 numbers are going to be what matters most. Isn't it true that the FDA will validate biomarkers for clinical trials, but require more comprehensive data for approved clinical use? The 6 posters Creatv unleashed at ASCO this year suggests they are moving right along and making the right moves... and Cytodyn/leronlimab are a big part of that.
Finally, I was curious about your 3rd point in your post: " Natera’s existing partnerships with Merck (and other Big Pharma leaders) mean they will likely have early, live data points of leronlimab's molecular response data." Are you implying Natera would share Cytodyn's ctDNA data from this trial with their Big Pharma buddies? I would be freaking furious if they did. Cytodyn pays them to use the Signatera test... not to share it. Will Natera even see the data, or have access? I should think not... unless there is something in the contract that allows Natera to incorporate results into their data-base. Which wouldn't happen until the trial is finished, and the results public, I would think.
But I am not in business, much less the pharmaceutical business. So I am pretty naive about this stuff. I mean, it's close to 5pm right now... are Natera execs sitting down for a beer or a glass of fine wine with their Merck counterpoints, talking non-public ctDNA information from the Clover trial? It's an open-label trial, but isn't sharing that kind of granular information protected by patient privacy law? If those kind of buddy-talks are going on, I'd say the whole enterprise is way more corrupt than I thought. But if they aren't talking concrete numbers and patients, I could see one of those execs say "Wow, have you been tracking Cytodyn and the Clover trial? I can't disclose any numbers, but leronlimab is looking pretty darn good in MSS mCRC." Kinda like a form of conversational corruption... which I could understand. But "live data points of leronlimab's molecular response data"? That would be criminal behavior (legitimized in real life by conventional business practice). I'd sic Sidley Austin on them if I caught a whiff of that...
From a patient perspective, I think Creatv's test is also really crucial. The Signatera test tells you if your drugs are working... which is to say it is backward-looking. Of course that is crucial information, and if it can tell you that information in a couple weeks as noted in the Clover trial, well, that is virtually real-time compared to waiting for RECIST criteria: a couple of scans, 8 weeks apart. But LifeTracDx is going to tell the docs if you are eligible for an ICI, which is real-time, actionable information. Take the test, and if you meet the threshold, you get an ICI tomorrow. So if you are a patient, what would be more significant: Knowing your current drugs are working by ctDNA reduction (Natera), or knowing that your PD-L1 numbers hit the magic mark and you are immediately eligible for an ICI that will finish the job, and do it pretty quickly (Creatv)?
I agree that the Natera connection is huge. And their data-bank--something like 2 million records of the molecular dynamics of CRC patients and how they react to various drugs--won't that sort of serve as a virtual control-group for later studies? Unleash AI on that data-base, and compare it to the couple-hundred people that have taken leronlimab for cancer... That alone is probably worth whatever Cytodyn is paying them. But to an individual cancer patient--and their families and loved ones--those PD-L1 numbers are going to be what matters most. Isn't it true that the FDA will validate biomarkers for clinical trials, but require more comprehensive data for approved clinical use? The 6 posters Creatv unleashed at ASCO this year suggests they are moving right along and making the right moves... and Cytodyn/leronlimab are a big part of that.
Finally, I was curious about your 3rd point in your post: " Natera’s existing partnerships with Merck (and other Big Pharma leaders) mean they will likely have early, live data points of leronlimab's molecular response data." Are you implying Natera would share Cytodyn's ctDNA data from this trial with their Big Pharma buddies? I would be freaking furious if they did. Cytodyn pays them to use the Signatera test... not to share it. Will Natera even see the data, or have access? I should think not... unless there is something in the contract that allows Natera to incorporate results into their data-base. Which wouldn't happen until the trial is finished, and the results public, I would think.
But I am not in business, much less the pharmaceutical business. So I am pretty naive about this stuff. I mean, it's close to 5pm right now... are Natera execs sitting down for a beer or a glass of fine wine with their Merck counterpoints, talking non-public ctDNA information from the Clover trial? It's an open-label trial, but isn't sharing that kind of granular information protected by patient privacy law? If those kind of buddy-talks are going on, I'd say the whole enterprise is way more corrupt than I thought. But if they aren't talking concrete numbers and patients, I could see one of those execs say "Wow, have you been tracking Cytodyn and the Clover trial? I can't disclose any numbers, but leronlimab is looking pretty darn good in MSS mCRC." Kinda like a form of conversational corruption... which I could understand. But "live data points of leronlimab's molecular response data"? That would be criminal behavior (legitimized in real life by conventional business practice). I'd sic Sidley Austin on them if I caught a whiff of that...
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