Replies to post #203401 on Cytodyn Inc (CYDY)

[HyGro]

FDA Statement was because NP had misrepresented the trial outcomes in both the CD10 and the CD12 trials. NP claimed that CD10 NEWS2 met its endpoint in it's press releases -- It didn't. CD12 NP claimed the post-hoc subgroup analysis had statistical significance vs. placebo -- he manipulated the p-value using an inappropriate statistical method.
FDA guidance is clear, if you fail to meet ANY trial endpoints, no subgroup analysis will be considered for approval, it has value in informing future trials. period. LL failed to meet ANY trial endpoints -- either CD10 or CD12.

These are both misrepresenting and manipulating the data. The SEC calls it False and Misleading and it is illegal. Thus the SEC and the DOJ initiated an investigation in the company.

[misiu143]

Pinserkr …
Yes , all that was proven million times , and there is a need to talk more . Why ???

Dr Lalezari said many times , and he is very responsive , everyone confused may email him and ask again ..
According to him , protocol for CD12 given to FDA was for 4 doses ..at 0 , 7, 14 and 21 days ..

For no apparent reason FDA refused to approve this way , first they changed to 2 doses , at 0 and at 7 days only , and primary endpoint , mortality , they moved from 14 to 28 days ..
What a perfect sabotage of the protocol , design to fail ..
FDA and Fauci are very good in that , all the studies for HCQ were design to fail .

In CD12 there were 2 official groups .,
A..severe
B..critical

All together in entire CD12 SS was not met , problems noticed later , like wrong age distribution , the oldest patients were in LL arm , and the youngest , the healthiest in placebo ..
Was that an accident , was that another sabotage , was Amarex just neglectful , or was it something more behind this ..

But with all of this we have a very good results in group B , critical patients ., unbelievable good !!!
It was 100% prove that LL saving lives , and not only without one serious side effect , but it look that LL repair some side effects due to some toxic SOC drugs ..
there was less side effects in LL arm , then placebo ( SOC)

What a drug !!

At 14 days there was 82% mortality benefit above all SOC
And even at 28 days , 21 days after the second dose , there was 31% mortality benefit ABOVE all SOC .

And this was with only 62 patients , as we know the smaller the group , the more difficult is to prove benefits , this is why most of the studies of these worthless , toxic drugs are with 1000s of patients , and even then they showing “ trending “

And what FDA do ..
Carrying for American people FDA said , they will not look at “ some “ subgroup results .

They looked and approved “ trending “ results of this toxic drug Remdesivir when Fauci told them .
They show later some positive results , but ONLY when Fauci or Gilead doing the studies , hmmm , interesting …

As FDA said in a hit letter , they will not look at some subgroup good results ..

This subgroup is a group B in CD12 , and the people in it are people on the ventilators and ECMO without one good drug approved for them ..

They all fellow Americans , our families and friends ..

FDA know ( they not stupid ) LL is the ONLY drug saving life’s ., what’s an indifference in this people , observing almost 1 mill death , and doing nothing about it ..

And soon after they approved Biogen drug for Alz..

--Drug showing no clinical significance..
--no primary endpoint,
--no p-value..
And up to 30% of patients developing as a side effect , cerebral edema and/or cerebral bleeding..

What a terrible indifference !!!
What a corruption..

All imo .,