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Dieselpro

03/05/21 11:36 PM

#150399 RE: ClosetInvestor #150397

"and three FDAs denied an EUA" this is just completely false. Nothing has been denied much less EUA. EUA will be approved for Leronlimab to treat covid-19.

BreezeWoodAcres

03/05/21 11:37 PM

#150400 RE: ClosetInvestor #150397

In a sense you are right. During EINDs they stated that anecdotes don’t come off of echmo. Also they touted that the sickest of sickest near death and ventilated came back from death and some after 3 days extenuated by themselves. So to Monday morning quarterback, yes they probably should have just went for critical. But like most drug companies chasing Covid meant to do whatever was best at the time. Maybe protocol when it was drawn up seemed best to include severe also. Don’t forget in the beginning nothing was working. Everyone was going right to ventilation. But as virus progresses, the treatments became better and an understanding of what was working became the norm. So combining better treatments, a slowdown over the summer in cases and then a ramp up during second wave, treatments caught up to the virus. Same thing happened when Cd-10 was initiated. Very poor PE and protocols for trial doomed approval. That is why I feel the Longhaulers trial we should be pros by now. This is bread and butter for Cydy.

hitekmastr

03/06/21 12:50 AM

#150414 RE: ClosetInvestor #150397

You misread the report. CYDY didn't enroll "only 62" patients in the 384 trial - what they are doing is reporting on 62 patients who were on mechanical ventilators. The 384 patient trial was fully enrolled as previously reported. What we are waiting for now is the data on the other 322 patients.

CTMedic

03/06/21 7:08 AM

#150450 RE: ClosetInvestor #150397

Closetinvestor,

The trial would have been better served enrolling more critical than severe patients. Difficult to know in advance (ask Relief with aviptadil and worse mortality at 28 days).

I believe your statement three FDAs denied EUA is premature without any foundation in fact. I have seen no statements from any regulatory authorities.