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justdafactss

10/11/21 5:10 PM

#188893 RE: kgromax #188892

Naw, any DEBUNKED outdated info will suffice as tout material no matter what the FDA publicly said.

CytoDyn has publicly communicated differences in small subgroups from the CD12 trial (e.g., a sub-group analysis of 62 of the 394 patients studied) suggesting that the data demonstrated a mortality benefit in certain patients who had received leronlimab. Subgroup analyses have well-established limitations, especially in the context of a clinical trial that has failed to show a benefit in the overall study population. For example, subgroups are often small, and therefore imbalances are common. Here, the data from CD12 illustrated imbalances in mortality among subgroups, some favoring leronlimab and some favoring placebo. None of these analyses met statistical significance when using established and reliable analytical methods that correct for multiple comparisons. However, as noted above, such analyses may inform the design of future clinical trials investigating leronlimab for the treatment of COVID-19.
https://www.fda.gov/drugs/drug-safety-and-availability/statement-leronlimab?Mon,%2017%20May%202021%2014:59:28%20EDT
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misiu143

10/11/21 5:24 PM

#188894 RE: kgromax #188892

Thank you , but don’t bother yourself , no need to explain anymore to me , I understand fine medical studies..

I know how studies are done , I did some myself .

One should read the approved by FDA protocol. We not talking about some subgroups , we talking about 2 groups , specify and approved by FDA before study started,
So it is not important how many will try to confuse this study.
Picture is really simple..

I also know what companies need to do , and I know that companies need to do what is approved for them by FDA in the protocol ..

And I know other drugs results by their protocols , and I know our CD12 ..

In our Group B it showed definitely saving lives , above ALL other approved drugs in this pandemic …
So one will hope that dr Fauci and FDA will be happy and approve it very fast .,

But no , as an answer FDA posted a hit letter , at only working to save lives drug .

To what I know , only second hit letter on any company in the history of FDA .,

Letter who no one signed , Dr Woodcock emailed to someone she didn’t know or approved it .
And it is hard to find any information so far..

But it look that it might be discover who was behind it in some near future .,

And as Americans dying daily the best drug for covid , and the only one without one serious side effect is not approve .

After what happened to my son I am on a mission , I want all sick to be able to ask for Leronlimab , and not when they dying to get RTT , much much sooner without any problems , sickness is problem enough for a patient , and the family...

Is that to much to ask in our great USA .,


All imo


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The oNiOnHEAd

10/12/21 10:48 AM

#188966 RE: kgromax #188892

Are you saying that in the end the statistical analysis did not split the severe v critical patient outcomes? I get that you're saying it wasn't defined in the plan, but that doesn't seem to be a prerequisite for reaching the same results.