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Is anyone good at figuring out p values?
Approximately how many patients would need to be treated to get a p value of .05 if the treatment arm had a mortality rate of 9.6% and the placebo arm had a mortality rate of 13.9%?
This Monday will mark 4 weeks since the topline data was released. The announcement that HGEN has officially applied for an EUA could come at any time. With HGEN's history of putting out good news on Monday mornings, the last 5 or 10 minutes of power hour today might be a melt up.
The FDA might surprise everyone and grant the EUA soon. Lenz had support from the government before the trials even began. So they have been watching lenz closely all along. When the drug handpicked by the gov't has stat sig on its primary endpoint, an EUA can come faster than it took for other drugs.
CD16 being done in India because patients are recovering too effectively in the US? Seriously? Criticals in the CD12 had a mortality of 47% in the placebo arm and 38% in the leronlimab arm. But now too many are surviving?
I bet a lot of the CD12 trial sites told CytoDyn that they weren't interested in participating in the CD16.
Ivermectin is cheap and therefore intriguing. Duterte's own words. Leronlimab is expensive. No money, no honey.
I'm not saying that CytoDyn shouldn't have another trial to test the 4 dose theory on criticals. But to complain that leronlimab isn't already approved is ludicrous. Do your trial. If you get good data, come talk to me.
Right now everything rests on the theory that the critical patients need more than 2 doses. It is obviously the theory CytoDyn should embrace. But here is how drug development should proceed:
1. Develop a theory
2. Test the theory in a clinical trial
3. Look at the data when the trial completes
4. If it is good data, try for an EUA
Leronlimab's supporters are skipping steps when they complain that leronlimab hasn't been approved.
It is like you have announced leronlimab as MVP of the season before the season even began.
The FDA wants a whole trial to have stat sig at its primary endpoint. Leronlimab failed in both trials. They have to look at 14 days instead of 28 days with only a 16% slice of the trial. The very definition of cherry-picking.
Leronlimab's trials failed. Cherry-picking some good data doesn't deny the fact that the trials failed on the whole.
You're right. But below are exclusion criteria:
I'm going to agree with longs that the FDA might have given guidance to give only 2 doses. The reason is that they knew hospital resources were going to be stressed and they didn't want leronlimab patients to keep coming into the hospital to get their saline shot.
There was even talk at one time of patients getting their initial shot at the hospital and they would be taught how to do the second shot themselves at home and they be given a prefilled syringe to take with them.
The other strong possibility is that Nader decided on only 2 shots to make the trial cheaper. The one thing we do know is that we have no idea what actually happened because it is impossible to trust one word that comes out of Nader's mouth.
It is my guess that more leronlimab patients passed away than placebo patients in the severe group. We have literally been given zero topline data from the severe group. I'm pretty sure they'd be touting the severe results if they were even a little bit positive. So the opposite can be deduced.
What if leronlimab's trial had more overall deaths in the leronlimab arm in both critical and severe combined? If there were more treatment deaths than placebo in the severe arm, then it is likely that the whole trial had more deaths in the leronlimab arm since the severe arm of the trial was 5/6ths of the trial and the critials only had a 24% mortality benefit.