“If they are small issues and he has the occupan
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Posted On: 11/18/2020 1:01:08 PM
“If they are small issues and he has the occupancy data why hasn’t it been submitted.”
IMO, CYDY doesn’t have the occupancy data at this time. The leronlimab occupancy teat was developed by Incelldx and is property of Incelldx. That means the new lab(s) must develop their own receptor occupancy test for leronlimab and then run the test on the blood samples of the patients that the BLA requires data from. Another potential issue is the blood samples from the trial patients, which I’m assuming Incelldx has. If this is the fact, then the blood samples from the target patient population would need to be drawn again and sent to the new labs.
IMO, CYDY doesn’t have the occupancy data at this time. The leronlimab occupancy teat was developed by Incelldx and is property of Incelldx. That means the new lab(s) must develop their own receptor occupancy test for leronlimab and then run the test on the blood samples of the patients that the BLA requires data from. Another potential issue is the blood samples from the trial patients, which I’m assuming Incelldx has. If this is the fact, then the blood samples from the target patient population would need to be drawn again and sent to the new labs.
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