SouthernGold , - this is a very good read , I also saved that for the future.. Thank you.

"However FDA notes that a compressed drug development program must generate adequate data demonstrate that the drug is safe and effective "- ( in BTD section )

Everyplace , safe is before effective , the most important for FDA..

By now FDA knows safety of Leronlimab , this is why I believe very strongly , they might approve BTD and then the treatment with Leronlimab sooner than with any other drug so far ..

I am sure they never saw safer medicine treating very serious medical problems than here....



IMO as always.