Cytodyn Inc (CYDY)

[clambottler]

NO ONE wants you living an extra few days - unconscious - on a ventilator - in the ICU

the FDA does not
the Hospital does not
Your Doctor does not
Your insurance company does not
YOUR FAMILY DOES NOT - THEY SUFFER

...... THEY ALL WANT YOU TO GET OUT OF ICU AND GO HOME ......

The DSMC Told you it was a Fools Errand

That is WHY CYDY's own DSMC Data Safety Monitoring Board TOLD THEM Follow for 42 days - lets see if they go home ( unfortunately the CEO ignored that advice).

= they want you to GO HOME - they do NOT want you to stay living unconscious on a ventilator in the ICU and extra 3 or 5 or 10 days - there is NO benefit to Anyone by that = they want you to go home.

CYDY'S Own DSMC Told them change it to 42 days - the advice was ignored.

The DSMC is an INDEPENDENT board HIRED by CYDY to oversee the trial and to look at the data during interim looks - with the SPECIFIC JOB of making recommendations - that is what they are hired to do. CYDY's DSMC told them to change the endpoint to 42 days - CEO of CYDY Ignored That Advice.

The Steroids changed everything, the SOC Standard of Care Changed, Everyone was living 28 days --- GILD changed their endpoint for Remdesevoir, RLFTF/NEURORX changed their endoint for RLF-100 Aviptadil - No One has 28 day all cause mortality as an endpoint, they ALL changed - except CYDY.

Many shareholders have been deceived or fooled into focusing on 28 day mortality - when that is a complete waste of time and a ridiculous endpoint.


It is why responsible companies are using

1. clearance of respiratory failure
without relapse

2. leaving the ICU (which saves money )

3. And HOSPITAL DISCHARGE

as endpoints

CYDY claims a benefit in 28 day mortality

That means patients that died within 28 days
THAT DOES NOT MEAN THEY WENT HOME
THAT DOES NOT MEAN THEY LEFT THE ICU AND THE CRITICAL TIME CONSUMING AND COSTLY INDIVIDUAL CARE

That Does NOT mean they did not die at day 30 or 40 or 60
Sadly put - but to explain, you can keep almost anyone alive
for 30, 60, 90 days, even an unconscious brain dead victim of a severe car crash or a gunshot wound.


What Matters is who has respiratory clearance, leaves ICU, AND GOES HOME.


These are unconscious patients
deliberately made unconscious to be put on a ventilator
- If you have a ventilator - effectively a tube down your throat
you gag, so they are made unconscious,
so they do not gag, they have a gag reflex, as we all do.


The ENDPOINT is in and of itself A Complete Waste of Time
and is MEANINGLESS to the FDA.

28 days is Meaningless -- that is why the DSMC said follow 42 days
That is why the FDA said we WANT YOU TO FOLLOW THEM FOR 60 DAYS ( minimum ).


CYDY CLAIMS " > 65 years: All-cause mortality among > 65 years age group was 64% (9/14) within 28 days of treatment initiation in leronlimab + SoC group compared to 75% (3/4) in placebo + SoC group (Table 4-7).
EVEN If you accept it as true 9 Out of 14 Patients in a " 384 participants " Trial.

It is AGAIN - absolutely 100 % MEANINGLESS.
ASK CYDY - HOW MANY CRITICAL PATIENTS OVER THE AGE OF 65
WENT HOME
HOW MANY WENT HOME
( no one cares if they lived unconscious for 28 days only to die on day 30 )


And that is what the FDA has told you.
Do Not Blame the FDA. This is a very very simple fact.
False hope will not make the share price rise.


This is a complete disaster with financing / dilution expected imminently, they already filed to sell See the S-3 $ 200 MILLION worth of shares.
MARCH 03, 2021
https://www.sec.gov/Archives/edgar/data/0001175680/000119312521067849/d435677ds3.htm


READ the 8 - K
https://www.sec.gov/Archives/edgar/data/0001175680/000119312521073448/d145217dex991.htm


LOOK AT THE TRIAL ITSELF
https://clinicaltrials.gov/ct2/show/NCT04347239?term=leronlimab&draw=2&rank=5



What Is More Important ? Look At Their Other Endpoints:
Primary Outcome Measures :
All-cause mortality at Day 28 [ Time Frame: Day 28 ]
Day 0 refers to the data of randomization/first treatment.

NO ONE CARES -- if you are unconscious living on a ventilator for 28 days 30 60 90 What Difference Does it Make if you DO NOT GO HOME

Secondary Outcome Measures :
All-cause mortality at Day 14 [ Time Frame: Day 14 ]
Day 0 refers to the data of randomization/first treatment.
NO ONE CARES -- if you are unconscious living on a ventilator for 28 days 30 60 90 What Difference Does it Make if you DO NOT GO HOME


Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) [ Time Frame: Day 14 ]
A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
NO DIFFERENCE BETWEEN THE DRUG AND THE PLACEBO
PLACEBO DID JUST AS WELL


Change in clinical status of subject at Day 28 (on a 7 point ordinal scale) [ Time Frame: Day 28 ]
A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
NO DIFFERENCE BETWEEN THE DRUG AND THE PLACEBO
PLACEBO DID JUST AS WELL


Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. [ Time Frame: Day 14 ]
The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine
NO DIFFERENCE BETWEEN THE DRUG AND THE PLACEBO
PLACEBO DID JUST AS WELL



------------ PATIENTS ON LERONLIMAB WERE - NOT - SHOWN TO
A. Clear Respiratory Failure Earlier
B. Be discharged from ICU Earlier
C. GO HOME EARLIER


==== SO What difference does it make that 9 / 14 patients older than 65 lived more than 28 days ? NO NONE ZERO


NO DIFFERENCE BETWEEN THE DRUG AND THE PLACEBO
PLACEBO DID JUST AS WELL

Good Luck To All.
Let us hope a drug is found that works, for the patients, and their families. God Bless.
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