Here's my favorite part of the new interview from Dr. Jay. He's talking about the meeting with the FDA that will take place in the NEXT 2 WEEKS. And this is what he hopes it will do:

Quote:

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And that will give us the opportunity both to submit our proposed follow-up study in triple negative breast cancer, submit a compassionate use program in triple negative breast cancer, as well as do some redesign of our colorectal cancer, updating it with the information we have about PDL-1 and the role of using checkpoint inhibitors in this case in patients with colorectal cancer who started with cold cancers, hopefully received leromlimab, and then their tumors turn hot, at which point they become eligible for a checkpoint inhibitor.[/quote]

So he will present a case for redesigning the CRC study, and as I understand the above will lobby for patients whose PD-L1 is elevated to get a checkpoint inhibitor -- not a year later, but during the study.

We've seen in the TNBC studies that patients who did NOT receive an ICI eventually died -- over 70% in the first year. Since 88% of the TNBC patients responded to Leronlimab, and 100 % who then got an ICI are still surviving, this redesign should save something like 88% of the patients!

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