When it comes to the FDA new agreed to end point for the new USA Critical Covid trial. It’s the FDA saying put up or shut up… we didn’t get what we wanted end point wise in a “time for release from hospital.” We received survival… this means we have the opportunity to show one last time in Covid if we save lives or not.

Funny how they came around to us after the busiest part of the current endemic is receding and the new treatment with viral pills coming out by big Pharma now. Did they stall long enough for big Pharma to seek and then sell the pills that won’t really work? Another Gilead type moment for treatments that hardly work… it’s amazing that they push the drug use to big Pharma and to pills or just any treatment of big Pharma ahead of anyone else like us.

Are we getting a fair shake this time around? I sure hope so… I hope Leronlimab gets its minimum 30% or much more survival in critical patients and blows the doors off this trial. No thanks to a unfair FDA for pushing us to the hardest end point that no other drug has achieved. What other Critical drug is there? None… just us… if we are lucky enough to show the efficacy we hope and desire.

I would love nothing more than to see 4 weekly doses knock the socks off all the patients and we save them all. Then that allows us to throw it in the FDA’s face and rub it in. Wouldn’t that be satisfying? Hell yes it would be… let’s hope!