I'm thinking, that given a current FDA approval al
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I'm thinking, that given a current FDA approval already exists for regorafenib in MSS mCRC, what credence would you give to a potential fully funded combination trial with this Bayer drug?
And the validation of the combination of these drugs is so imperative for a future partnership with Bayer to happen, unless they would just buy us out after learning the single leronlimab arm exceeds the combo.
Regorafenib is a VEGF inhibitor and seems to do a very good job at inhibition. So much so that it causes a host of side effects involving immune suppression and potentially fatal liver problems. Given it's unspectacular medium overall survival I would suspect that Bayer is not overwhelmed with prescriptions.
Leronlimab downregulates VEGF but still allows normal functioning with other CCR receptors so you don't see the drastic side effects like regorafenib.
A single arm for leronlimab would not be mandatory so the claim could be made that the combo has great efficacy due to it's synergy. An approval with the combo would mean a tremendous boost in regorafenib sales. The same would happen with Keytruda. Since drugs in the U.S. are paid for almost solely by the government and insurance then sales would consist primarily of the combo. Sometime down the road word might get out that leronlimab alone doesn't have those side effects.
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The understanding that leronlimab is effective in the cold or MSS type tumors tells us we will achieve unassailable results in the leronlimab monotherapy arm, but then we would not get a partner. It would put us more in the Buy out category.
Any big pharma company funding a trial with us would want to control the partner drug. If they didn't have a buyout offer tied to the results of the trial then they're just dumb. As a contingent offer it would not have to be announced by Cytodyn until it became a solid offer.