I struggle to see why we don’t just get one thin

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I struggle to see why we don’t just get one thing done at a time

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If they did, it would take forever. CytoDyn would have no mono, tnbc, gvhd trials right now. They would be in a second combo pivotal trial, with probably 100-150 total patients in that setting, probably still enrolling 3 per month, not knowing if leronlimab would work in a mono or cancer setting. And most investors now wouldn’t have found CytoDyn.


I believe the BLA part 2 is done. Looks like they wrote two versions, depending on the fda dose decision, and will submit the version matching the decision. That tells me we are waiting on the fda. Over 50% of drugs approved have had two pivotal trials, including say IZ. The fda is using the mono trial to gather more data as opposed to requiring a second pivotal or larger combo. Hence what seems like a forever long wait as they fda requested more and more out of the mono trial.

Coronavirus is different, it is new, and the public is panicking, which puts enourmous pressure on them to speed up in that area. I would love for leonlimab to work with coronavirus, because it has the public eye and I could imagine a whole lot of people asking in that scenario, with this working in a mono setting for many people, and tested in over 800 people starting over a decade ago, with such low side-effects, no resistance, why hasn’t this been approved already.