Cytodyn Inc (CYDY)

[misiu143]

Few posters here asked me to explain again results of CD12, since not everyone understand well..
Sure..

Below is a PR from the company with Topline results.

As we know company applied for 4 injections during the study , for no know reason FDA changed their protocol to 2 , and only then approved it..

CD12 includes 2 groups..
--A severe
--B critical.

Entire CD12 , both groups combined together , results were not extremely good with the 2 injections only , not SS better then SOC ,
there were a problems including age of the patients were not well matched,
All together much less then what we expected to have with the 4 shots.

But if one look only on group B , 62 critical patients ..even with 2 injections study was very successful , and those were a very sick patients , on the ventilators and ECMO..

We know the smaller the study , the more difficult is to prove the success , drug must be exceptional to be able to do it..
Success here with only 62 patients is really telling ..

Results showed that leronlimab saving lives , and 2 more injections at 14 and 21 days are needed for even better results..
What else one need to know in the pandemic when people dying all around to get an EUA..

In CD12 ALL patients were on SOC drugs ..
Then some in addition received leronlimab , and some placebo, but All patients were on SOC , so when we compare to placebo , we really compare to SOC drugs.

Injection was given at 0 and 7 days.

--And at 7 days , group receiving leronlimab
" experience a mortality rate 78% lower then placebo (SOC )"
This mean there was 78% mortality benefit in leronlimab ABOVE placebo ( SOC drugs )..

--at 14 days it was 82% .
82% mortality benefit ABOVE all SOC drugs.!!!
How many lives could be save using leronlimab.

Since there was no more leronlimab given after day 7..

--at 21 days , this number went to 50%

--and at 28 days , when there was no more effect of leronlimab in the system, mortality benefit ABOVE SOC drugs was 31%...

But this is still 31% ABOVE ALL the SOC drugs..

This is not 31% compare to 30% , or whatever number could be for SOC drugs,
This was 31% ABOVE SOC..!!

This numbers showing clearly that leronlimab is saving lives in a critical patients , there is no question about it.

FDA should give EUA at this point for this group of patients , and advice to use 4 doses..
And if this will happened probably hundred thousands less will die.

But instead , FDA decided to put a hit letter on the company ,
i was told only for the second time in the history of FDA thing like that happened...

And they did that during a week of congressional meetings in Philippines , when they were deciding if to give EUA to ivermectin and leronlimab..
And serious talks were going on in India at the same time.

I hope that Americans will learn one day what FDA did , and evaluate if what they did was good for them.

Again , hopefully it is clear that the 31% mortality benefit at 28 days is ABOVE SOC results, not next to it.

This information is below in a PR , if anymore questions on the subject.

BTW , those numbers from critical were never retracted by the company , or disputed by FDA.
FDA just decided not to talk about them as it is "some subgroup" as they call them ..
But this "just subgroup " as FDA called , are critically ill , dying people without one good drug approved for them.

And this study showed less side effect with leronlimab arm then with SOC plus placebo , which telling me that leronlimab even corrected some side effects produced by SOC .

All imo.

And in the PR below there are also 4 secondary endpoints met with group B on CD12 study , please read.


https://www.cytodyn.com/newsroom/press-releases/detail/533/cytodyn-to-submit-newly-completed-topline-report-of-cd12