Lerolimab does not have a serious side effect, it is the most important item for FDA, so FDA request CYDY to give it to patients with life-threatening mTNBC, although it has not yet been tested in humans for this indication, CYDY receives Phase II for all new indications. I do not see that there is any conspiracy with the FDA.
Leronlimab is also highly effective and there is a big need for resistant patients.
But it is still a new way of treating HIV-1 patients and the FDA wants and can seek the standards they want, often varying from indication to indication, from drug to drug. When all this is done, then there will be approval, which I do not doubt. Our problem is finances and this is not a concern of the FDA, it is a responsibility solely on the NP. And the NP is waiting for the FDA to complete the BLA because only then can it conveniently settle our finances and move out of the OTC, because if we were not at the OTC we would have other options even now.IMO