Replies to post #50082 on Cytodyn Inc (CYDY)

[branster]

Emergcy/Guru Well the bottom line is the BLA is delayed but ultimately after submission we need approval which will be determined in 2020, yes we lost several months but in the big picture if approved this opens the door even wider for the cancer application assuming we continue to see positive results there. I am still unclear about the Mono pipeline being if the patients have approval for combo I see them eventually figuring out they do not need the other drugs and stick with just ours.

[ohm20]

The delay isn't the problem of FDA, NP should have never asked for 725 unless he wouldn't have been sure he would not get the approval for 500 mg, but I understood that everyone was very happy with results of 500 mg.

The FDA wanted to see a greater than 70% response rate for the monotherapy trial. The 525mg dose response rate at the time was exactly 70%. With no safety issues it made perfect sense to get IRB approval for a higher dose. There should have been no expectation that the FDA would interfere with a completely different trial that had our drug in use with other drugs.

But the BS goes back even farther than that. We were denied orphan drug designation (which would have fast tracked everything) by the FDA in combo because with monotherapy we might have over a 200.000 patient population. The combo study was a standalone study and at the time of denial we had not proven out monotherapy.

With leronlimab the FDA pisses around while people die and they should be held accountable for that. Now that NP has the ear of a couple of Congressmen he should bring that up.