The way I understand it, the usual process that Big Pharma would follow in getting access to an investigational new cancer drug would be to acquire the drug via license or buying the company outright, then do a trial to establish efficacy in a specific indication. If it beats the standard of care and is reasonably safe, then it becomes the new SOC. That's standard operating procedure for developing drugs. If it's an effective drug, like Keytruda, then keep testing it in different cancers, with different drug combinations that you own or license, trying to beat the SOC in each and every indication. But if leronlimab works the way we think it does--when paired with virtually any ICI, including the generic ones on the horizon--perhaps the new, improved, get-new-drugs-to-the-people-faster FDA will okay some kind of blanket approval of the combination, no doubt with some kind of post-approval, Phase 4, confirmatory trials in the various indications. As these ICIs go generic, there would be some real financial considerations for the FDA to do this--controlling metastasis and producing a high percentage of complete responses would substantially reduce the national burden of cancer treatment. Medicare, Medicaid, and the politicians would be very, very, very happy. Big Pharma... not so much.
Now don't get all excited about this; I personally don't think it will happen... Or put it this way--I'll believe it when I see it. The FDA would have to change it's way of doing things, and Big Pharma would likely resist, throw it's weight around, and cry like a baby with a broken toy. But who knows, in a democracy, anything can happen. Anyway, the above is a very aspirational possibility rather than a practical pathway. And it would probably set off a heavyweight legal and political battle that might take years to work out. So it ain't gonna help the share price in the near term, unlike a partnership with a company that has an ICI ready to go. A company that has the financial muscle to reasonably quickly establish a new standards of care in a bunch of indications. Little ole Cytodyn might very well do that in TNBC and mCRC all by themselves; one of the toughest cancers out there, and one of the largest indications.
That's why there is so much discussion on the board about accelerated approvals and fast tracks and vouchers--those are much more realistic paths for getting leronlimab to patients, indication by indication. The possibility of curing cancer will certainly get people's attention... but will it move mountains and get the FDA to act quickly? I kinda wish I could go to bed tonight and wake up in June, or next fall, when we will have more substantial data. Maybe a partner. And a more substantial share price. Unassailable proof takes time tho. But this slow unfolding drama is taking something out of me. I wanna hear about a bunch of complete responses in the mCRC trial! And see some of the Ladies tell their stories on national TV! That would be very satisfying.
Now don't get all excited about this; I personally don't think it will happen... Or put it this way--I'll believe it when I see it. The FDA would have to change it's way of doing things, and Big Pharma would likely resist, throw it's weight around, and cry like a baby with a broken toy. But who knows, in a democracy, anything can happen. Anyway, the above is a very aspirational possibility rather than a practical pathway. And it would probably set off a heavyweight legal and political battle that might take years to work out. So it ain't gonna help the share price in the near term, unlike a partnership with a company that has an ICI ready to go. A company that has the financial muscle to reasonably quickly establish a new standards of care in a bunch of indications. Little ole Cytodyn might very well do that in TNBC and mCRC all by themselves; one of the toughest cancers out there, and one of the largest indications.
That's why there is so much discussion on the board about accelerated approvals and fast tracks and vouchers--those are much more realistic paths for getting leronlimab to patients, indication by indication. The possibility of curing cancer will certainly get people's attention... but will it move mountains and get the FDA to act quickly? I kinda wish I could go to bed tonight and wake up in June, or next fall, when we will have more substantial data. Maybe a partner. And a more substantial share price. Unassailable proof takes time tho. But this slow unfolding drama is taking something out of me. I wanna hear about a bunch of complete responses in the mCRC trial! And see some of the Ladies tell their stories on national TV! That would be very satisfying.
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