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HUT 8 PUMP AND DUMP SCHEME ?
Does any one here trust one word from the CEO's mouth ?
SUE = CON ARTIST ? -- LISTEN TO WHAT SHE SAYS
We had to do the financing NOW
because the bitcoin price could go down
And we need the money to buy more mining equipment
more sites, and more power
What Does SUE Not understand ?
IF THE BITCOIN PRICE GOES DOWN
YOU DO NOT NEED MORE MACHINES TO MINE BITCOIN
Sue ?? You Had to SELL SHARES NOW
To BUY MORE MACHINES
Because you expect the Bitcoin PRICE GOES DOWN ???
You Had to SELL SHARES NOW
to Buy more Sites and More Power ?
Because you expect the BITCOIN PRICE GOES DOWN ??
Con Artist - You Decide
WORST MANAGEMENT EVER You Decide
SUE --- HOW MANY MACHINES DO YOU PLAN TO BUY
WHAT IS THE GOAL
When You Anticipate the Coin Price would Go Down
( Your stated reason to sell 33 % of the float now )
Listen to the tape -
Maddstacker --- give us your opinion
Maddstacker
So the NASDQ listing some have said
Is in ONE WEEK - claimed to be JUNE 15
------------------------------------
And MANY believe the share price may go to $ 7.00
or even $ 10
After NASDQ listing
That is fair to say, right ???
-------------------------------------------
And YOU THINK Management is smart to do a fundraising NOW
Instead of waiting say ONE MONTH
For the listing and the shareprice to go up and stabilize higher
???????
Is that what you are saying???
MY OPINION +HUTMF Management has proven themselves to be
either complete idiots and the WORST MANAGEMENT EVER
OR Con Artists and Thieves And the WORST MANAGEMENT EVER
luring people in with the
Nasdq news, after claiming it was top secret for months
and then slamming investors with this fundraise.
So tell us
Do you really think raising funds now is a great move
with the NASDQ listing scheduled for JUNE 15 ?
Do you think the price will go DOWN June 15 when they are NASDQ listed
so now is the smart time to raise money ????
IF YOU Believe the share price will go up if and when NASDQ listed
Is selling 100 MILLION worth of shares at $ 5 CAD
Better than say selling 1/2 as many shares at $ 10 CAD ?
SHOULD WE GET RID OF HUTMF MANAGEMENT ???
ARE THEY THE WORST
OR WORSE SIMPLY CON ARTISTS AND THIEVES - WHICH I HATE TO SAY IT
IT SEEMS TO APPEAR THAT WAY. ???
But Muddstacker, let us know what you think.
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HUT Management CON ARTISTS AND THIEVES ???
Here is an idea
Let us keep nasdq listing a secret and let the stock get buried
Let us wait until BITCOIN goes from 64 K to 37 K
And THEN
Let us Do A FINANCE and Sell MILLIONS of SHARES
5 DAYS BEFORE NASDQ listing
So we sell at the bottom.......
Hutmf Management - the absolute Worst
Who is advising these clowns ???
No One Has ANY faith in HUT Management
they are the worst -
They come off as either complete idiots
or con artists and thieves -
EITHER MANAGEMENT GOES
OR SHAREHOLDERS DO
AND IT APPEARS ALL SHAREHOLDERS ARE RUNNING OUT AS FAST AS POSSIBLE
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HUTMF The WORST management - The Appearance is Con Artists and Thieves
HUTMF The WORST management - The Appearance is Con Artists and Thieves
1. Months ago Every other company addressed NASDQ listing. BFARF even Digihost
HUT said it is a secret. HUT was not allowed to discuss it. HUT could not disclose it - but everyone else could
HUT came off as liars and thieves, The WORST management
No one believe them - lost all credibility
2. HUT Finally disclosed Nasdq intentions
The STOCK PRICE is sure to go up when listed
BITCOIN trading at a 5 month low
So DO NOT WAIT - do a 100 ml financing now ?
when in two weeks if nasdq listed the share price will go higher
Raise Funds Now at a low and drive the stock lower
Do not wait until a month or two after listing and raise at a higher price ???
HUTMF has the worst management
When will the management be removed ? -
No One Has ANY faith in HUT Management
they are the worst -
WHEN Bitcoin Trading at 60
If HUT reported their Nasdq plans instead of saying they had to keep it a secret ( appears a complete LIE - No ONE else had to keep it a secret )
they could have raised funds based on a $ 10 US share price
The management Has Got To Go
The appearance is liars and thieves, and every month
they seem to make it worse
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It Does Not Matter What The Truth Is - Correct or Not - It Matters What People Think The Truth Is
CYDY PR: "Given the size of this critically ill population relative to the trial’s size (62 out of 384 patients), the Company has concurrently filed an additional protocol with the FDA using the existing sites from its CD12 trial to quickly enroll patients in this population during the pendency of these ongoing regulatory discussions. The Company has continued to enroll patients (45) through the open-label arm of the CD12 trial, and is working with regulators here and abroad to expedite this process."
CYDY got a pop out of EUA announcement, turns out they never
" officially " filed -
I would imagine the FDA may do the same/require the same of RLFTF/NEURORX
as above, at the minimum
Having already established this requirement I find it hard to believe they would treat Javitt preferentially - I do not think they can given CYDY and the similarities
But that would not stop apparently Javitt from claiming EUA application as CYDY did.
So this remains a very tough call - often in life if one is willing throw professional and moral obligation and reputation out the window, anything can happen.
It Does Not Matter What The Truth Is - Correct or Not - It Matters What People Think The Truth Is
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This is a very tough call
Sentiment counts - and as you can see - the sentiment here is high
I think mainly due to the lack of disclosure from the company
but that is what it is - opinions may differ
That is as mentioned in part why I write on message boards or read them anyway, to guage sentiment. Also - to see if my opinion could be changed hoping that if my thought was wrong someone would correct it. The purpose of these boards in my opinion.
Anyway - CYDY has in my opinion even worse results
but the CEO is apparently able to " cherry pick " data and publish
" percentages " again based on a small "N" which makes said percentages effectively meaningless.
Anyway - this could pop on just the announcement of EUA application
No matter common sense or reality, people want to believe.
One way to play it is invest now for the EUA application announcement hope for a pop in price and immediately sell.
Short term my opinion has changed = Javitt seems to offer no hesitation to sell this to anyone I watched his Cheddar interview .
I had thought Javitt would release results from 60 day none have appeared.
But long term my opinion stays the same based on data disclosed to date, there is Not possible eua based on data where he removed 1/2 or more of the patients from the trial. I think it would be a year or two investment and I do not want to be parked that long, opportunity is everywhere.
Javitt continues to fail to disclose the number of patients at the Regional Hospitals
fails to disclose the results of the Regional Hospitals
ONLY discloses " percentages " of alleged benefit claimed at the TERTIARY hospitals WITHOUT disclosing any patient figures.
Initially I bought shares here with the belief that Javitt was far and above NADER of CYDY in all aspects of professional and personal character.
My opinion has unfortunately changed, but that is what it is.
People will invest in anything - so if he does announce an EUA application which he may, this may well go up. My personal hunch now is Javitt will do anything to make the BRPA merger happen -
That said GEM owns billions of shares of RLFTF and the shares issued outstanding are in the billions --- so any pop is likely inhibited compared to BRPA and likely shortlived - again if I do decide to enter ( I own a few shares had a much larger position earlier ) I will be buying with the full intent of immediate exit - and watching.
I have invested my monies elsewhere with less risk and equal or greater opportunity so not sure I will get back in for the EUA play. Probably not - but maybe.
Good Luck to All
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Thanks Bill B EIND or EAP Not EUA
I believe you refer to this quote:
" NeuroRx Says COVID-19 Drug Improves Survival If Overstretched ICUs Excluded "
Lets say that is correct, Javitt excludes " Overstretched " ICU's.
OR those " over capacity ".
So:
Is Javitt asking the FDA to approve the drug
But
that the drug is ONLY to be given to hospitals that are not crowded ?
=======================================================
You see throughout the US and Internationally different hospitals
different " regions " have different standards of care based typically on finances, but of course, overcrowding could add additional limitations in care.
But isn't that in Fact what an EIND or EAP does ?
Special investigational new drug (IND) application categories allow patients who meet specific criteria to receive treatment with non-approved drugs. The FDA approves over 99% of all single-patient INDs, providing emergency approval within hours, and non-emergency approval within an average of 4 days.
https://www.sciencedirect.com/science/article/pii/S2452302X17302917
And Javitt already has that up and running:
https://clinicaltrials.gov/ct2/show/NCT04453839?term=aviptadil&draw=2&rank=3
.......
I just cannot see EUA.
I can't see a need. Because in large part I do not see the proof.
Javitt again, has NOT disclosed how many patients
were treated at the tertiary hospitals, nor the exact data.
And has not shown the difference in care, why he claims the Regional Hospitals did worse.
I wonder why he has not shown the data ???
................. Well just my wondering.
Hopefully he gets us more information soon !
And the patients and their families are able to benefit !!!
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EIND - NOT EUA - ? Hi Pennyworld I don't think it works that way
I think we first have to ask - What is Javitt asking the FDA for ?
Is Javitt asking the FDA to approve the EUA use of the Drug, with the Limitation that it can ONLY be used at Tertiary Care Hospitals,
and further limited to Tertiary Care Hospitals with the same degree of care that the Tertiary Care Hospitals provided in the Trial ?
IF SO - why not just continue the EIND ?
At those same hospitals ??
=====================================================
=====================================================
You see if my hunch is correct - and I believe it is
127 patients at 6 Regional Hospitals and 4 tertiary Hospitals
by removing the 6 ( majority of treatment likely ) Regional Hospital Data
Without providing any patient numbers
we have no idea how many patients in the 6 Regional Hospitals that he removed
we have no idea how many patients were treated in the Tertiary Care Hospitals
It's just too difficult to know
Even giving the benefit of the doubt, let us say 75 patients ( to avoid argument ) were treated at the 4 hospitals
50 on drug 25 on Placebo
It is Just Too Small for FDA approval of EUA or final
But EIND would be fine and the patients would get the drug at the doctors discretion
-------------- OK lets say I am wrong ------------
Let us say the FDA wants to look further ----------
What is Javitt applying for
EUA approval of the use of Aviptadil/Zyesami/RLF-100
at ONLY tertiary care hospitals
No Regional Hospitals are included or permitted to use the drug ?
Can Javitt even explain the difference in care the patients received ?
Is he able to show How the patients were treated differently at the Tertiary Care Hospitals and got apparently much worse care at the Regional Hospitals.
And are all Tertiary Care Hospitals the same
even if the Regional Hospitals can somehow be proven to be different ?
Can Javitt show all - ALL - Tertiary care hospitals are somehow different from Regional but offer the same care ?
--------------------
Is that what Javitt would ask for
EUA approval of the Drug, with the Limitation that it can ONLY be used at Tertiary Care Hospitals ( No Regional Hospitals permitted )
AND Only at Tertiary Care Hospitals offering the same degree of care that the Tertiary Care Hospitals provided in the Trial ?
I think when you think about it, it just does not make any sense.
Well it makes no sense to me.
So:
1. What is Javitt actually applying for ???
AND
2. Why has Javitt NOT told us the number of patients that were treated at the Tertiary Care Hospitals
Was there a significant Number of Patients ?
3. Why has Javitt NOT told us the number of patients that were treated at the Regional Hospitals and how they fared ?
THEN:
4. How were the Regional Hospital patients treated differently ?
Where did the Regional Hospitals go wrong ?
5. What did the Tertiary care Hospitals do correctly,
and How can we be sure ALL Tertiary Care Hospitals will provide that same care ?
.... Well when we have those answers, we could probably make a better guess.
Right now I guess 2 % chance of EUA approval ( really 0 % but I am being kind ) and 0 % chance of FDA approval
without additional trial(s).
Rest assured additional trials are planned and one initiated recently I believe. We shall see. I opine it will just take time
But to be candid, the more I think about it, it may never be approved for Covid, Unless he explains where the Regional Hospitals Went Wrong.
+++++++++++>>> But this is why these message boards are nice
it makes for rational and respectful conversation much of the time
Your opinion is most welcome.
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Javitt will not file the EUA - not yet - is my bet
Javitt is a reputable doctor with apparently a long history at the FDA
Javitt will not file an EUA - well probably not, I believe he knows full well there is limited to no chance of EUA approval, at least not on the data he has provided to us.
Javitt does NOT want to embarrass himself with his peers. Rest assured, no one does.
Remember:
127 HFNC patients
10 Hospitals
6 Regional Hospitals
4 Tertiary Training Hospitals
And apparently in the results we have viewed, he removed data / all patients from the 6 Regional Hospitals.
Presuming 1/2 ( my guess 6 Regional hospitals enrolled at least 1/2 of the patients that the 10 hospitals in total did )
1/2 127 = 63.5 - so its a 63 patient trial probably at best probably fewer
notice NO ONE HAS SAID HOW MANY PATIENTS WERE AT THE HOSPITALS - meaning NO DATA on the 6 regional hospitals NO MENTION OF the number of patients at the 6 Regional Hospitals
NO MENTION OF THE NUMBER OF PATIENTS at the 4 tertiary training hospitals
Let us say 75 patients were enrolled at the 4 tertiary hospitals giving the benefit of the doubt ( I think that is a really really fair benefit of the doubt --- seriously I imagine 6 REGIONAL hospitals would enroll more than 4 tertiary hospitals )
At 2:1 enrollment I think you will find that means 50 patients on the Aviptadil/Zyesami RLF-100 arm ( they keep changing the name of the drug ) and 25 patients on Placebo
2 patients on drug for every 1 patient on placebo.
Is the FDA really going to issue an EUA on data from a 75 patient trial where after the 196 patient trial closed Javitt effectively removed 2/3 of the patients from the data ?
Seriously a 75 patient trial ?
Ehhhhhhhhhh Ahhhhhhh Uuuummmmmmmmm Ppprrreeettttyyy Uuuggggghhhhlllly
No
Not happening
I think everyone realizes by now that we need another trial
there just isn't enough here.
Well just my opinion, guess, hunch and surmise. If you can find trial approvals on such a small number of patients ( number of patients is referred to as "N" ) any trial, at any time, in the history of the FDA, that the FDA approved something on a 75 patient trial please do let me know.
Thanks.
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Thank you Pennyworld
actually there are a few reasons I post
Among them and Selfishly perhaps
1. If I am incorrect or missed something, I hope someone will correct me
also when I write things out sometimes it keeps it fresh in my mind and I think about it more
2. I personally interpret or take This and other sites as a forum, designed for or the purpose of which is where the ' small investor ' can share information
I receive information from posters, so I like to share the information that I have
You, I, and all of us of course are welcome to make our own opinions from the information shared, never advice to buy or sell a stock, simply information shared.
Lets hope we can all save or even make a few bucks together.
rational and reasonable responses not only welcome but hoped for.
They reposted the SSRN paper
so that you may see my quotes are accurate
and form your own opinion
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3794262
Let us hope the drug works, for the patients and their families
God Bless
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JAVITT'S BIG SPIN - Part 4
You can see now that the media is catching on
NeuroRx Says COVID-19 Drug Improves Survival If Overstretched ICUs Excluded
Will Seek EUA Shortly
01 Apr 2021
NEWS
Andrew McConaghie
andrew.mcconaghie@informa.com
Executive Summary
Therapy shows some promise in helping COVID-19 respiratory failure patients but the US FDA may question company’s data cut.
https://scrip.pharmaintelligence.informa.com/SC144107/NeuroRx-Says-COVID-19-Drug-Improves-Survival-If-Overstretched-ICUs-Excluded
============================================
Therapy shows some promise in helping COVID-19 respiratory failure patients but the US FDA may question company’s data cut.
====================================
Reminder:
Javitt SSRN QUOTEs:
" Setting: Ten US-based acute care hospitals, which included 4 tertiary care teaching hospitals and 6 regional hospitals. "
" Participants: 196 patients with PCR+ Critical COVID-19
treated with High Flow Nasal Cannula (HFNC: n=127)
Non-Invasive Ventilation (NIV: n=32)
or Mechanical Ventilation (MV: n=36). "
===============================================
Participants: 196 patients
REMOVED 32 patients treated with Non-Invasive Ventilation (NIV: n=32)
REMOVED 36 patients treated with Mechanical Ventilation (MV: n=36).
127 patients treated with High Flow Nasal Cannula (HFNC: n=127)
REMOVED ALL patients treated at " 6 regional hospitals "
Data / analysis = claim of significance provided on patients treated at
" 4 tertiary care teaching hospitals "
NUMBER of patients treated at " 4 tertiary care teaching hospitals "
NOT PROVIDED
==============> many of these hospitals have an inherent bias when treating patients on drug, they just cannot help themselves, it is human nature, nothing mischievious / intentional <==============
My Bet Opinion Hunch Surmise Guess - Javitt knows this Javitt knows this all too well
There is no chance of EUA or maybe a 2% chance
and there is 100 % chance that NO APPROVAL on this trial - its impossible.
Unfortunately the trial for ' approval ' purposes is a disaster -
We do not know how much of a disaster because:
JAVITT removed the 6 REGIONAL HOSPITAL data - so we do not know how many patients he removed and have no idea how those patients fared
and We do NOT KNOW how many patients were treated at the " 4 tertiary care teaching hospitals " -
how many received aviptadil/zyesami
though presume they were enrolled 2:1 per protocol.
In Short - a do over - will have to wait another 6 months perhaps more for the I Spy or other trial results.
Good Luck to All
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Someone who has a world saving drug
stands on the mountain
and screams it over and over and over
and they put those good results anywhere and everywhere
NeuroRx
Hiding from Calls
Not returning calls
Ending the Conference Call early - what was it 1/2 hour
Termination after one question
RLFTF
Not showing up for or participating in the conference call
Denying receipt of results
Claiming no knowledge
NEURORX and RLFTF neither of them willing or publishing results
speaks for itself.
It really is that simple.
Good Luck
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ellk quite unfortunately for you - it appears that you skimmed it too quickly. I suggest you read a little more thoroughly.
I won't waste my time correcting your entire post but here are two tidbits.
1. " robust overall significance " there is no such thing well there is because they just made up those words, but it is misleading and disregarded by the FDA and really is well, misleading, very unfortunate they chose those words. Medically speaking robust overall significance is 100 % meaningless.
Pay attention to """" statistical significance """" that is the only thing that matters.
2. My posts are truthful and accurate. Long story short.
NeuroRx did not release data, they gave simple percentages based on mined or "" Cherry Picked "" data ( that they again, did not disclose )
RLFTF was called and RLFTF claims they were not given the data and cannot comment. You probably notice RLFTF did not join in or participate in the conference call - and you know RLFTF is the patent holder and partner.
NeuroRx was called and they did not take the call nor did they return the call later on.
Someone who has a world saving drug
stands on the mountain
and screams it over and over and over
and they put those good results anywhere and everywhere
NeuroRx
Hiding from Calls
Not returning calls
Ending the Conference Call early - what was it 1/2 hour
Termination after one question
RLFTF
Not showing up for or participating in the conference call
Denying receipt of results
Claiming no knowledge
NEURORX and RLFTF neither of them willing or publishing results
speaks for itself.
It really is that simple.
Good Luck
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Hi Pegs and Penny
I am not shorting the stock. Never was short and do not recommend a short of the stock.
I actually believe that Javitt believes this drug has the propensity to save the world, or at least 100s of thousands of patients. I do too.
But if you are invested I believe it needs to be a long term investment 2 to 3 years.
This is a situation where the initial results show promise. The drug will probably need to be formulated in the dry formula for the inhaler and put through trials; Hopefully by I Spy and in Europe by Relief.
Those trials I suspect will take a minimum of a year, but they may not start until the formula and dose is obtained. Another PII/PIII with a much greater number of patients. So this may take a good bit of time.
Hopefully the formula could be obtained and delivery inhaled and a new PII would allow EUA at some point, as the PIII Completes, but I just do not think it will happen based on this data that has been provided.
The drug showed promise. But the delivery and the dose needs refining. Javitt went with 3 dose intervenous because that is what the prior testing had done, and they had limited time and limited ability for testing. This was the time of covid when the trial initiated - they were in panic mode everyone was trying their best to get trials up and running, since then the standard of care specifically proning and steroids changed dramatically but HFNC did too. Wide use of HFNC was NOT forseen when the trial initiated. The change in the standard of care was not foreseen.
If you read some of the EIND data, they were continuing well past 3 dose inhaled and were getting decent results. The key being in my opinion, the increased production of surfactant. They appeared to be healing lungs, including lung transplant. The ACE 2 receptor also plays a role, but I believe the drug must be utilized again longer, but earlier too. That key ACE2 role is to stop viral replication.
The increased production of surfactant is really amazing, at least to me, and is what made me pay attention. If you do not know what surfactant is, it should be researched you will find it interesting.
Rest assured the FDA is very interested in this drug, or I Spy would not be involved.
Once the formula is created they will test, inhaled, and earlier meaning in covid earlier stage disease, and longer meaning additional/continued doses; physicians discretion.
They will also test in lung transplant, and lung damage from say smoke inhalation. There is a ton of promise here. It will just take time.
There are many applications possible. Increased surfactant may be amazing.
So if invested and as always just my opinion, just know you will have to hold tight for a few years. And hopefully be rewarded.
Unfortunately testing takes time and money and this will be a very expensive ordeal.
But let us hope the drug works for the patients and the families.
Good luck to all investors; hopefully there is something here.
I have been in and out and in and out as a shareholder, and may get back in once I learn additional information / data.
And of course like all my posts, this is just personal opinion based on very limited knowledge of the results; in large part as I believe the results have not been released.
Javitt appears a very honest person, I do not think this a stock swindle, and do not think they will dilute with selling more shares without a specific goal in mind. Though dilution is likely to pay for expenses including testing.
Not happy the way the results were presented; but do hope for the best.
And you never know maybe the stock triples tomorrow, I do not know, I just do not plan on that.
Good Luck
God Bless the patients and their families.
Hi Bridgrace - Javitts 10 PAGE SSRN Paper
Hi - this is the abstract from Javitt's 10 PAGE published paper
You can copy and paste and google and look up the full 10 pages, I cannot print 10 pages here - and of course give us your opinion
when making my opinion I go by Javitts PUBLISHED writings more than a PR
SO I have no misconceptions
I have and rely on what JAVITT said in his published report
==================================================
Here is What Javitt Wrote on February 28, 2021
JAVITT WROTE THIS - NOT ME OR SOMEONE ELSE - NOT A PR
A PUBLISHED PAPER
=====================================================
Methods: Randomized prospective double-blind placebo-controlled trial with 28 day and 60 day endpoints .
Setting: Ten US-based acute care hospitals, which included 4 tertiary care teaching hospitals and 6 regional hospitals.
Participants: 196 patients with PCR+ Critical COVID-19 treated with High Flow Nasal Cannula (HFNC: n=127) Non-Invasive Ventilation (NIV: n=32) or Mechanical Ventilation (MV: n=36).
Intervention: Participants were randomly allocated to intravenous aviptadil (synthetic VIP) or placebo at a 2:1 ratio, in addition to maximal standard of care (SOC). Participants received 3 successive 12-hour intravenous infusions of Aviptadil at 50/100/150 pmol/kg/hr or normal saline placebo, each day for 3 consecutive days.
The main outcome measure was cumulative probability of time to recovery from respiratory failure without relapse and with survival through day 28 and through day 60. Secondary endpoints included time to ICU discharge, time to hospital discharge, NIAID ordinal scale, and survival lifetable. Analysis was by intent to treat.
Results: Overall, 91 of 131 Aviptadil-treated participants survived to day 28 compared to 47 of 65 placebo-treated patients (70.6% vs 71.7%; P=NS).
Among those treated with HFNC (n=127), the main outcome measure demonstrated a trend in favor of the drug treated group (Hazard Ratio 1.53; P=.08).
Participants treated in tertiary care hospitals demonstrated a greater effect (HR 1.84; P=.058).
A 10 day median difference in hospital length of stay was seen in all HFNC patients (P=.006) and a thirteen day difference was seen in those treated in tertiary care centers (P=.004), with both differences favoring treatment with aviptadil.
No drug-related serious adverse events were seen in either group. The only adverse event reported more frequently in drug- vs. placebo-treated participants was mild to moderate diarrhea (30% vs 1.5% P<.001), which was expected.
At 28 days, a smaller percentage of Aviptadil-treated vs. placebo-treated participants remained hospitalized for respiratory failure (37% vs 51%).
The study was insufficiently powered to detect differences in outcome among patients treated with non-invasive and mechanical ventilation and no differences were detected.
===================================================
The study was insufficiently powered to detect differences in outcome among patients treated with non-invasive and mechanical ventilation and no differences were detected.
======================================================
Effectiveness of ZYESAMI™ (Aviptadil) in accelerating recovery and shortening hospitalization in critically-ill patients with COVID-19 Respiratory Failure: interim report from a phase 2b/3 multicenter trial
10 Pages Posted:
Jihad G. Youssef
Houston Methodist Research Institute
Richard Lee
University of California, Irvine
Jonathan Javitt
Johns Hopkins School of Medicine; Potomac Institute for Policy Studies; NeuroRx
Philip Lavin
Boston Biostatistical Research Foundation
Dushyantha Jayaweera
affiliation not provided to SSRN
Date Written: February 28, 2021
Hi Pegs1 - Here Lies the Shenanigans
Javitt ran a trial with 196 patients
that is very very very small for an FDA approval
but probably enough for an FDA EUA
EUA is kind of like a temporary approval until better trial is done
EUA says well there appears to be no harm, but maybe maybe some good
so we will take our chances until a bigger trial is complete
This is how I understand it, and I could be wrong, if wrong I not only desire correction, I insist on it. I hope NeuroRx and Relief will correct this immediately if wrong.
So I understand that when writing up the most recent PR
Javitt took patients out - Javitt intentionally deleted certain patients from the data,
by doing this
he made a small trial borderline really really questionable number
He started with 196
He removed 68 patients 32 patients treated with Non-Invasive Ventilation (NIV: n=32) 36 patients treated with Mechanical Ventilation (MV: n=36).
Now you have a trial for a drug to treat millions but only data from 127 patients
THEN he says but does not provide the figures
OF THE 127 HFNC Patients he wants to look at
He ONLY wants to look at the data from the HFNC patients at the 4 tertiary training hospitals
AND apparently REMOVES all HFNC patients ( we do not know how many ) that were cared for at the 6 regional hospitals.
SO he cuts the trial from 196 to 127
and then cuts it some more, maybe in half maybe more
removes the patients on ventilator and machine
removes patient data from 6 hospitals
keeps patients from 4
Only wants to examine the HFNC patients at 4 tertiary training hospitals
maybe lets guess
1/2 of the HFNC patients were at 6 regional hospitals
and 1/2 of the HFNC patients were at the 4 tertiary care training hospitals
So lets say for the benefit of the doubt 75 patients
Lets guess 75 patients were HFNC at the 4 tertiary care hospitals
Javitt NOW wants to look at 75 patients the HFNC at tertiary training hospital ? It maybe less, let us just say 75 it is an easy number to work with
IF enrolled 2:1 that means 2 aviptadil patients per 1 placebo patient
That means 50 patients on aviptadil/zyesame compared to 25 patients on Placebo
And Javitt wants the FDA to administer this drug to patients ? Based on that ?
I will tell you frankly NOT GOING TO HAPPEN
Look at the vaccine trials 1000 10,000 30,000 patients
Look at RGEN And others hundreds and thousands of patients
Javitt asking for approval on 75 patients
Is it a fiction
Is it a tall tale
Is it bologna - a bologna sandwich
I call it shenanigans tomfoolery
really really shameful that data is presented like this
is this persons opinion.
I am 98 % sure Javitt knows there is not a chance in heck that this will get and FDA EUA and a 100% chance not FDA approval.
Well - thats me and my opinion
I mean, I really really don't want to say it is a fraud, that is strong language, I won't say this is a fraud, but I probably wouldn't argue strenously if someone said, that looks like a fraud
it kind of does - but I think it is better known as " data mining "
I call it data mining
I hope someone will call Javitt or RLFTF and ask a very very simple question
HOW MANY OF THE 127 HFNC PATIENTS WERE TREATED AT THE 4 TERTIARY TRAINING HOSPITALS ?
and then ask IF YOU REMOVED PATIENTS FROM THE 6 REGIONAL HOSPITALS
WHY ON EARTH DID YOU DO THAT ????
-- interesting to say the least, I just hope we get some more data and maybe Javitt has a really good explanation - boy I would love to hear that explanation.
Lets hope the drug works for the patients and the families
God Bless !
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WHY DID RELIEF SAY THEY HAD NO DATA ?
Apparently a well known and reputable analyst attempted to interview or at least discuss the data with Relief and with Javitt/NeuroRx
"Finanz und Wirtschaft",
Quote
"Relief Therapeutics' potential corona drug has provided good trial data. Fewer of the patients who received it died, and many recovered more quickly than those who were given only a placebo in addition to standard therapy.
Once again, however, the communication leaves something to be desired. This time, the partner company has them to blame.
NeuroRx worded the media release in such a way that even two seasoned pharmaceutical analysts could not tell my colleague whether all the data led to the statistically significant effect or only part of it. This is quite relevant, for the size of the market and thus also the share valuation.
Because either the drug worked in all categories of patients or only in a part.
Relief's communications officer also didn't know the answer, and surprisingly, a high-ranking Relief representative wouldn't say anything either. They had not yet seen the data, he said.
NeuroRx didn't hear the request for clarification on Monday and didn't feel compelled to do so by our deadline on Tuesday either. I just can't trust companies like this enough and am keeping my hands off the stock. "
=============================================
Interview of Relief """" Relief's communications officer also didn't know the answer, and surprisingly, a high-ranking Relief representative wouldn't say anything either. They had not yet seen the data, he said.
""""
""""" They had not yet seen the data, he said. """
Interview of Javitt/NeuroRx """" NeuroRx didn't hear the request for clarification on Monday and didn't feel compelled to do so by our deadline on Tuesday either. """"""
==================================================
.........hmmmmmmmm
Is it odd that the patent holder and the " partner "
on the world's life saving drug
Is not or claims not to be privy to any of the data ?
......
Is it Odd that the Company NeuroRx claims to have a life saving drug, a drug to save the world, and does not take a call nor respond to an inquiry.
......................
How are we, doctors, or the FDA even - to know what to make of this
How can anyone treat a patient, much less convince a hospital to administer a drug --- if there is no data available ---
if the patent holder and partner does not even have the data
and no one will respond to questions about data ???
Odd right, very very Odd, a life saving drug hidden from the very people that need it, is that what we are to believe ?
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JAVITT'S BIG SPIN = PART 3
He removed 68 patients completely :
32 patients treated with Non-Invasive Ventilation (NIV: n=32)
36 patients treated with Mechanical Ventilation (MV: n=36).
AND PERHAPS WORSE
OF THE 127 HFNC Patients
He apparently removed all patients treated with HFNC at the 6 Regional Hospitals ( Were we to believe NO patients were treated with HFNC at 6 Regional Hospitals ? I do not know -- I presume there were )
AND he does not tell us HOW MANY patients were on HFNC at the 6 Regional Hospitals
AND he does not tell us HOW MANY patients were on HFNC at the 4 tertiary care teaching hospitals
AND I HAVE TO IMAGINE far fewer patients were treated at the 4 tertiary care teaching hospitals then the 6 Regional Hospitals
--------------------------------------
CALL JAVITT AND ASK HIM
HOW MANY PATIENTS ON HFNC WERE TREATED
1. ON AVIPTADIL/ZYESAMI at the 4 Tertiary Care Hospitals
2. On PLACEBO at the 4 Tertiary Care Hospitals
The numbers of patients are likely SO SMALL
that this study is absolutely meaningless
A> NO CHANCE AT EUA
B> ABSOLUTELY 100 % NO CHANCE AT FDA APPROVAL
Based on this test
well just my opinion ASK JAVITT
Do not ask me ASK JAVITT.....
======> this post like all of my posts are my own speculation and conjecture based on limited information not advice to buy or sell a stock
VERIFY ALL DATA call the company and verify all data, this is limited information based on what I have read, please do correct if wrong or an error
I not only want correction I insist on it
Good Luck to all - but especially the patients and their families, let us hope the drug works or another is found for them
God Bless.
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JAVITT'S BIG SPIN = PART 2
Participants: 196 patients
Enrollment at a 2:1 ratio
meant 131 Aviptadil patients were enrolled
and 65 Placebo patients were enrolled
==========================================
Those enrolled were at different stages
OR were treated differently depending on Where enrolled
127 patients treated with High Flow Nasal Cannula (HFNC: n=127)
32 patients treated with Non-Invasive Ventilation (NIV: n=32)
36 patients treated with Mechanical Ventilation (MV: n=36).
================================================
Setting: Ten US-based acute care hospitals,
4 tertiary care teaching hospitals
6 regional hospitals.
====================================================
Results: Overall,
91 of 131 Aviptadil-treated participants survived to day 28
compared to 47 of 65 placebo-treated patients
(70.6% vs 71.7%; P=NS).
NO DIFFERENCE between Placebo and Drug Aviptadil/Zyesami
After 28 days
91 of the Aviptadil patients were alive ( 70.6% )
47 of the 65 Placebo patients were alive ( 71.7%)
( yes a GREATER percent of placebo patients were alive
but there is no difference, because and exactly why small numbers
are meaningless )
============================================
The study was insufficiently powered to detect differences in outcome among patients treated with non-invasive and mechanical ventilation and no differences were detected.
==================================================
So what is LEFT ?
HFNC AT TERTIARY CARE HOSPITALS
NOW NOW the Most RECENT PR
GENEVA, SWITZERLAND / ACCESSWIRE / March 30, 2021 / RELIEF THERAPEUTICS Holding AG (SIX:RLF)(OTCQB:RLFTF) ("Relief")
states:
The prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals.
" at tertiary care hospitals. "
NOTICE HE TOOK OUT THE HFNC PATIENTS TREATED AT THE 6 REGIONAL HOSPITALS
Setting: Ten US-based acute care hospitals,
4 tertiary care teaching hospitals
6 regional hospitals.
84% of HFNC patients treated at tertiary medical centers with RLF-100(TM) survived to day 60 compared with 60% of those treated with placebo (P = .007).
""" treated at tertiary medical centers """"
AGAIN HFNC PATIENTS TREATED AT THE 6 REGIONAL HOSPITALS APPEAR TO BE REMOVED
++++ NOTICE --- HE DOES NOT TELL YOU HOW MANY PATIENTS WERE ON HFNC AT THE 4 TERTIARY CARE HOSPITALS
NOR TELL YOU HOW MANY PATIENTS ON HFNC WERE TREATED AT THE 6 REGIONAL HOSPITALS
========================================
========================================
NOW NOW the Most RECENT PR
GENEVA, SWITZERLAND / ACCESSWIRE / March 30, 2021 / RELIEF THERAPEUTICS Holding AG (SIX:RLF)(OTCQB:RLFTF) ("Relief")
states:
"""" According to NeuroRx, across all patients and sites, RLF-100(TM) met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site """""
====================================
In My Opinion that is data mining and quite unfortunate.
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JAVITT'S BIG SPIN = PART 1 DATA MINING
Here is What Javitt Wrote on February 28, 2021
=====================================================
Methods: Randomized prospective double-blind placebo-controlled trial with 28 day and 60 day endpoints .
Setting: Ten US-based acute care hospitals, which included 4 tertiary care teaching hospitals and 6 regional hospitals.
Participants: 196 patients with PCR+ Critical COVID-19 treated with High Flow Nasal Cannula (HFNC: n=127) Non-Invasive Ventilation (NIV: n=32) or Mechanical Ventilation (MV: n=36).
Intervention: Participants were randomly allocated to intravenous aviptadil (synthetic VIP) or placebo at a 2:1 ratio, in addition to maximal standard of care (SOC). Participants received 3 successive 12-hour intravenous infusions of Aviptadil at 50/100/150 pmol/kg/hr or normal saline placebo, each day for 3 consecutive days.
The main outcome measure was cumulative probability of time to recovery from respiratory failure without relapse and with survival through day 28 and through day 60. Secondary endpoints included time to ICU discharge, time to hospital discharge, NIAID ordinal scale, and survival lifetable. Analysis was by intent to treat.
Results: Overall, 91 of 131 Aviptadil-treated participants survived to day 28 compared to 47 of 65 placebo-treated patients (70.6% vs 71.7%; P=NS).
Among those treated with HFNC (n=127), the main outcome measure demonstrated a trend in favor of the drug treated group (Hazard Ratio 1.53; P=.08).
Participants treated in tertiary care hospitals demonstrated a greater effect (HR 1.84; P=.058).
A 10 day median difference in hospital length of stay was seen in all HFNC patients (P=.006) and a thirteen day difference was seen in those treated in tertiary care centers (P=.004), with both differences favoring treatment with aviptadil.
No drug-related serious adverse events were seen in either group. The only adverse event reported more frequently in drug- vs. placebo-treated participants was mild to moderate diarrhea (30% vs 1.5% P<.001), which was expected.
At 28 days, a smaller percentage of Aviptadil-treated vs. placebo-treated participants remained hospitalized for respiratory failure (37% vs 51%).
The study was insufficiently powered to detect differences in outcome among patients treated with non-invasive and mechanical ventilation and no differences were detected.
===================================================
The study was insufficiently powered to detect differences in outcome among patients treated with non-invasive and mechanical ventilation and no differences were detected.
======================================================
Effectiveness of ZYESAMI™ (Aviptadil) in accelerating recovery and shortening hospitalization in critically-ill patients with COVID-19 Respiratory Failure: interim report from a phase 2b/3 multicenter trial
10 Pages Posted:
Jihad G. Youssef
Houston Methodist Research Institute
Richard Lee
University of California, Irvine
Jonathan Javitt
Johns Hopkins School of Medicine; Potomac Institute for Policy Studies; NeuroRx
Philip Lavin
Boston Biostatistical Research Foundation
Dushyantha Jayaweera
affiliation not provided to SSRN
Date Written: February 28, 2021
=====================================
THIS SSRN PAPER WAS POSTED THEN RETRACTED BY JAVITT OR OTHER FOR REASONS UNKNOWN - I DOWNLOADED IT ==========================
Ram Places his Honor and Reputation Above what appears to be silly Nader and Javitt data mining
Friends of Ram will tell you, he has a duty to Wainright and he is not going to get involved in this.
Appears Ram is unwilling to sully his entire professional career on data mining and possibly intentionally misleading investors.
I believe Ram should be commended, and not criticized.
Well thats my belief and opinion.....based on very little information. Unfortunately NeuroRx said to send in questions and apparently they went unresponded to -- and NeuroRx said to ask questions in the call which apparently were dropped after the very first question.
Seems like a page right out of the CYDY book. Yet again of course just my opinion and my guess, based on very little information. Not advice to buy or sell a stock. CALL THE CEO do not ask me - I certainly know less than RLFTF claims to know.
NeuroRx did NOT include Ram and RLFTF on the call - I see that as extremely odd - and a bit worrisome. Opinions may of course differ.
But here is an expert opinion that was posted :
"""" Relief's communications officer also didn't know the answer, and surprisingly, a high-ranking Relief representative wouldn't say anything either. They had not yet seen the data, he said.
""""""
Are we to believe the the patent holder - the partner of NeuroRx, is not privy to any data ?
Are we to believe the RLFTF company has information that can save the world, and remains silent, keeping doctors from using the very drug they need ?
===========================================================
"Finanz und Wirtschaft", a leading institution, Ram refuses contact
and Javitt apparently leaves calls unanswered:
Here's a translation:
Quote
"Relief Therapeutics' potential corona drug has provided good trial data. Fewer of the patients who received it died, and many recovered more quickly than those who were given only a placebo in addition to standard therapy. Once again, however, the communication leaves something to be desired. This time, the partner company has them to blame. NeuroRx worded the media release in such a way that even two seasoned pharmaceutical analysts could not tell my colleague whether all the data led to the statistically significant effect or only part of it. This is quite relevant, for the size of the market and thus also the share valuation.
Because either the drug worked in all categories of patients or only in a part. Relief's communications officer also didn't know the answer, and surprisingly, a high-ranking Relief representative wouldn't say anything either. They had not yet seen the data, he said. NeuroRx didn't hear the request for clarification on Monday and didn't feel compelled to do so by our deadline on Tuesday either. I just can't trust companies like this enough and am keeping my hands off the stock."
Javitt = Nader - Two Peas in a Pod
Did you see how Nader and CYDY
took the lead from Javitt today
And CYDY was able to """ Do "further statistical analysis " """"
Amazing right, magically there is a benefit, it only took a few weeks and a few different ways to look at it ------------------------
It's a Miracle !!!
For Today CYDY reports through " further " mining
" It Was Revealed "
Thank the Gods !
=========================================================
VANCOUVER, Washington, March 30, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, is pleased to announce further results from its CD12 trial of severe-to-critically ill patients with COVID-19.
Upon further statistical analysis of the critically ill population (hospitalized patients receiving invasive mechanical ventilation (IMV) or ECMO), it was revealed that when leronlimab was added to standard of care (“SoC”), leronlimab decreased mortality at 14 days by 82% (p=.0233, N=62). Patients who received leronlimab were over five times more likely to be alive at day 14 than those who received SoC only.
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Javitt = Nader - Two Peas = Continued ( see prior post too )
Did you see how Nader and CYDY
took the lead from Javitt today
And CYDY was able to """ Do "further statistical analysis " """"
Amazing right, magically there is a benefit, it only took a few weeks and a few different ways to look at it ------------------------
It's a Miracle !!!
For Today CYDY reports through " further " mining
" It Was Revealed "
Thank the Gods !
=========================================================
VANCOUVER, Washington, March 30, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, is pleased to announce further results from its CD12 trial of severe-to-critically ill patients with COVID-19.
Upon further statistical analysis of the critically ill population (hospitalized patients receiving invasive mechanical ventilation (IMV) or ECMO), it was revealed that when leronlimab was added to standard of care (“SoC”), leronlimab decreased mortality at 14 days by 82% (p=.0233, N=62). Patients who received leronlimab were over five times more likely to be alive at day 14 than those who received SoC only.
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Javitt and Nader = Two Peas in a Pod.
Surprisingly, to this share holder anyway, is the way that Javitt and Nader are so alike.
I really thought there was a difference, in that Javitt was and is a physician, a doctor, a man of principle and moral ethic.
But the data mining similarities are striking.
The same method of using a small "n"
data mining it
and throwing out rough percentages - with NO patient data
No Nothing.
Dr. Javitt, can you tell us - what happened to discharge from the hospital ? What happened to early discharge from the ICU ? Will we get any data, or just these Nader like data mining rough percentages ??
================================================
RADNOR, Pa., Feb. 23, 2021 /PRNewswire/ -- NeuroRx, Inc. announced today that the Phase 2b/3 trial* of ZYESAMI™ (aviptadil, previously RLF-100™) for the treatment of Respiratory Failure in critically ill patients with Covid-19 has demonstrated multidimensional benefit around its prespecified primary endpoint of Recovery from Respiratory Failure with discharge from hospital and ICU (without relapse) by day 28 in patients with critical Covid-19 who were treated with High Flow Nasal Oxygen.
"""" prespecified primary endpoint of Recovery from Respiratory Failure with discharge from hospital and ICU (without relapse) by day 28 in patients with critical Covid-19 who were treated with High Flow Nasal Oxygen. """"
RADNOR, Pa., March 29, 2021 /PRNewswire/ -- NeuroRx, Inc. today reports 60-day results of the Phase 2b/3 trial of intravenously-administered ZYESAMI™ (aviptadil acetate) for the treatment of respiratory failure in critically-ill patients with COVID-19, which is being developed in collaboration with Relief Therapeutics Holding AG (SIX:RLF, OTCQB:RLFTF). Across all patients and sites, ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013)
"""" the primary endpoint for successful recovery from respiratory failure at days 28 """"
-------------------------------------------------------------
So suddenly "discharge from hospital and ICU " is not so important ?
" without relapse " is just ignored ???
-------------------------------------------------------------
Doctor - did you just switch the endpoints on us ?
-------------------------------------------------------------
Is anyone starting to see it now ?
They are mixing words,
Intentionally deleting some words
And completely changed the claim from a month ago ??
Did I get that right ?
Buehler
Buehler
Or is it Nader ?
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FDA APPROVES USE - ONE (1) PATIENT IN PHILIPPINES
" the Republic of the Philippines, Department of Health, Food and Drug Administration (“Philippines FDA”) has approved the use of leronlimab to treat a COVID-19 patient under Compassionate Special Permit (“CSP”) pursuant to FDA Order No. 2016-005. "
You have been Nadered.
Ohhh geeez what a disaster.
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EARLY RELEASE FROM HOSPITAL - YES ? Aahhh NO ??
March 29
Across all patients and sites, ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and also demonstrated a meaningful benefit in survival (P = < .001) after controlling for ventilation status and treatment site.
February 09
With the improvement in survival since the start of the pandemic, differences in patient survival were not seen at day 28, and patients are now being followed through day 60. The study has not identified an overall difference in the stated primary endpoint of recovery from respiratory failure from summary data.
----- There appears to be No survival benefit, but there is after
" after controlling for ventilation status and treatment site. "
March 29
Recovery from respiratory failure (without relapse) with discharge from acute care and survival through the observation period was the prespecified primary endpoint specified by FDA for the study, originally intended to be assessed at 28 days and then extended to 60 days based on recently-published FDA guidance.
NO DATA/FIGURES NO MENTION OF DISCHARGE
February 09
This difference includes at least a five-day median reduction in hospital stay. (P=.043). The largest difference observed was among those treated with HFNC who experienced a median of 11 fewer days in hospital (15 vs. 26).
----> Why NO mention of reduction in hospital stay in the March 29 pr ?
That leads me to believe there were NONE ?
JAVITT - Please do NOT be another NADER !
Geez
WHERE IS THE DATA ????
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Insiders Dumping their Resticted Shares causing price downward spiral ?
Do you all believe the paralegal and the CYDY staff has completed the removal of the legends on the restricted shares and are dumping them like crazy now ?
I do - all the signs are there. Good Luck.
SELLING and laughing all the way to the bank.
Rule 144 allows public resale of restricted and control securities
https://www.sec.gov/reportspubs/investor-publications/investorpubsrule144htm.html
Do you think CYDY Has their Paralegal working on this right now ?
Paralegal
Job Reference:237516631-2
Date Posted:27 February 2021
Recruiter:CytoDyn
Location:Vancouver, Washington
Salary:On Application
Sector:Legal
Job Typeermanent
Job Description
Reports to: General CounselCompensation: Commensurate with experienceHours per week: Full Time
About CytoDyn Inc.CytoDyn is a publicly traded late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. It has filed a BLA with the FDA and, if approved, commercial sales could commence in early 2021. The Company is also rapidly exploring COVID-19 and various cancer indications. The Company recently filed a BLA for HIV with the FDA and, if approved, commercial sales could commence in early 2021, or sooner. The Company is also rapidly evaluating its drug, leronlimab, to treat COVID-19 and various forms of cancer. Leronlimab is in a class of therapeutic monoclonal antibodies designed to address unmet medical needs in the areas of Human Immunodeficiency Virus ("HIV", Cancer, and Immunology. With respect to HIV, the CCR5 receptor appears to play a key role in the ability of HIV to enter and infect healthy T-cells. The Company's lead product candidate, leronlimab, belongs to a class of drugs known as entry inhibitors. These therapies block HIV from entering into and infecting certain cells. With respect to Cancer and Immunology, the CCR5 receptor also appears to be implicated in human metastasis and in immune-mediated illnesses such as triple-negative breast cancer, other metastatic solid tumor cancers, graft-vs-host disease ("GvHD", and Non-Alcoholic Steatohepatitis ("NASH". More recently, the Company is expanding the clinical focus with leronlimab to include evaluating its effectiveness in multiple other autoimmune indications where CCR antagonism has shown initial promise, as well as COVID-19. The Company targets leronlimab treatment as a therapy for patients who experience respiratory complications as a result of contracting COVID-19. The Company believes that leronlimab provides therapeutic benefit by enhancing the immune response while mitigating the "cytokine storm" that leads to morbidity and mortality in patients experiencing this syndrome.
Summary of PositionThe Company is seeking a high-performing paralegal interested in gaining hands-on experience at a publicly traded company assisting with the administration of securities and other tasks. You will have the opportunity to play a key role assisting with the end-to-end administration (issuances, exercises, transfers, etc.) of warrants, RSUs, options, stock subscription agreements and other investor documents.
Additionally, you will assist in the processing of restricted stock legend removal and Rule 144. This position will interact with outside legal counsel, investors, transfer agent, brokerage firms, and the finance team. You will also assist with the administering of securities and investor related documents for execution via DocuSign.Work StyleAbility to effectively function, prioritize, and execute in a fast-paced, dynamic environment.Flexible, fearless, and excited about your part in our growth.You like to take on new challenges and take the initiative.Proactive resourcefulness and initiative to ask questions coupled with the ability to self-manage.You're willing to help wherever needed.Attention to detail and strong organizational skillsDrive to do what it takes to ensure the job is done.A learner with a mindset centered around continuous improvement.Thrive operating in a rapid growth environment.Expert at applying past relevant experiences to define, create and implement best practices.QualificationsExperience with publicly traded companies.
Good understanding of securities law, restricted stock, SEC registration statements, and Rule 144, or strong willingness to learn.
General understanding of SOX 404 and implications of following internal controls and processes.Ability to establish priorities, meet deadlines, multi-task, work independently, and execute objectives with minimal supervision.Excellent teamwork and collaboration skills.Proficient in Microsoft Office.Good sense of humor.
BenefitsSalary commensurate with experienceStock option compensationPTOCompany holidays401(k) plan with 3% safe harbor contribution after 90 days of employment.100% company paid medical/dental benefits for employees and all dependents.Flexible Spending Account ("FSA" allowing employee to set aside pre-tax wages for medical costs.Company-paid parking in onsite parking garage.
thanks John - this was another one - the head line
" NeuroRx Announces Completion of Data Analysis "
But in the body " The results for the primary endpoint of recovery from respiratory failure and the secondary endpoint of survival through day 60 are in the process of final review by the investigators of the multicenter clinical trial. "
So --- I get the link thinking wow, yes, its " Complete " ?
Then I get the game, well its not quite complete
we are doing " in the process of final review "
----- If this idiot comes out at the conference call and says
our final review is not complete - I cannot answer that question yet
or we are not sure yet - maybe we will apply for EUA the final review is not complete
--- well I don't know what to say other than what a ( choose your own profanity )
and given his prior antics or mistakes, or releases too early or retractions,
I actually think that could happen.
I had a ton of faith and respect for Javitt early on, his claims they were working 24/7 the FDA would call or respond at 2:00 a.m. on a saturday
but it turned into fumbling and bumbling , papers corrected two or three times, papers published and retracted ,
credibility destroyed
I hope it is restored on Monday.
P.S. You think Sami gave two shites about his birthday
no one does for f sake get your documentation together
and present a thorough and professionally prepared study
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Reading between the lines on Javitt
My personal opinion, is Javitt is either a buffoon akin to the antics we viewed with CYDY Nader or possibly a great scientist but the worst businessman
Query,
i. if the drug works we all witnessed the stock brpa go to 60, on just a hope that it works,
so why on earth would he, and he did, sign up for a brpa $ 10 ml financing at a $ 10.00 share price CONTINGENT on the drug working and the brpa merger going through.
it makes no sense. it is like the absolute worst possible business decision ever ever if the drug actually works
rlftf got a much better round for the same $10 ml.
reading between the lines, Javitt knows and is telling us all he needs more time and money to get anywhere and therefore was happy to get $ 10 a share months from now IF the merger goes through
ii. where is rlftf ? neurorx is making an annoucment that could save the world, why is there absolutely no mention of rlftf and ram in the announcment,
and why has rlftf and ram chosen NOT to announce anything ?
RAM hello, RAM your drug is saving lives and you are silent - you are absent
what is the problem ram ?
Unless you course you do not want to mislead anyone so silence is with intent ?
iii. why did Javitt on the last conference State ahead of time on linked in that it would be about the partnership only, and not the results, and then why did he in fact release the poorly worded PR about the results
iv. why did Javitt publish the SSRN paper, and then retract it without any explanation at all
v. why did Javitt and Clinigen announce to all that they were discontinuing the EAP at all but certain sites, well the public report posted was the the EAP was being ' wound down ' without mentioning any sites indicating all sites
why didn't Javitt get up and speak to that and explain it ?
vi. why would you not overlap EAP and EUA if you were getting EUA why wouldn't you contine EAP until the EUA was set up and just transition in
if doctors and staff are training and learning when handling EAP
and they would smoothly transition into new patients under EUA
why on earth would you shut down the EAP sites, taking away drug and training ?
----------------- everything Javitt has said and done has indicated there is no possible EUA - simply not possible
either that or he is the absolute worst business person out there
The manner he has acted has been far far from the professional manner I expected when I first purchased the stock
this is a clown show to date, lets hope he completes the sentences and shows us something monday, frankly I am tired of reading between the lines and getting left out on the laundry line blowing in the wind
for the patients and their families let us hope there is something here and he does not show himself to be another Nader. Lord Knows the world does not need another Nader.
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REPORTED ! CEO NADER SPOTTED PUTTING ON HIS
FLEECE JACKET
Explaining the Results and the CYDY Benefit !!!
In the Light Most Favorable - setting aside failure in all endpoints
And setting aside the tricky small print language of ' commonly used treatment ' or such other nonsense the thing is filled with.
Let us take CYDY Greatest Claim to Fame - cutting out the fat and the rancid,
let us look at the Meat they say is good to eat.
"All-cause mortality among critically ill patients was 28% (12/43) with leronlimab + SoC
and 37% (7/19) with placebo + SoC
at day 28 (Table4-6).
This
is approximately a 24% relative reduction in mortality."
The numbers are Tiny Tiny -- such that
ONE patient JUST ONE out of 19 makes a difference.
6/19 in the placebo group would have been 31.5%,
Which when you consider 19 patients its simply NOT different from 28 %
If the whole improvement comes down to one patient, it's pretty much impossible to rule out chance.
This is a nothing. An absolute nothing.
And the trial has to be redone with new patients and new endpoints.
NOW add in the claim they will fill this trial in months ?
Seems highly unlikely.
1.SUMMER is coming - we had a big reduction last summer
2. COMPETITION is everywhere - people have choices
3. VACCINES are taken by a high portion of the population
4. SOC changed Standard of Care changed - you are getting a lot less Critical
Each of the 4 items contributes to a reduced critical patient count.
So Good Luck.
$ .85 -===> the price currently ( $2.1600 ) gives the CYDY company a 1.3 billion market cap
they are worth around Maybe Maybe (many other better companies with greater pipelines are valued at ) $ 500 million.
ADD IN:
5. They need money desperately - they do not have money to do more trials
6. The insiders are apparently selling, removing the legends from the restricted shares
7. They already filed an S-3 to sell up to $ 200,000,000 worth of shares - filed on March 03.
ADD UP 1 - 7:
$ .85 is a very reasonable and rational estimate of the price in 3 months or less ( should be now ).
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+++ Posted 03 10
looks like people are starting to realize
CEO NADER SPOTTED PUTTING ON HIS FLEECE JACKET
WHile Remdesevir is contraindicated for some patients, for use over long periods of time.
There is little to No None Zero contraindication for short term use ( covid ); except in the exceptional case / a very very small percent maybe 1 - 2 %.
_ MISIU if you have any publication that states or reports the FDA EUA approved drug remdesevir carries a contraindication for covid PLEASE post it immediately.
.
That is why the FDA has allowed, and continues to allow its use
for covid.
To say it is contraindicated for short term use is in my opinion
Not Accurate = Not true.
To say it is contraindicated for some, for long term, yes.
But that is not what is happening with Covid treatment.
Explaining the Results and the CYDY Benefit !!!
In the Light Most Favorable - setting aside failure in all endpoints
And setting aside the tricky small print language of ' commonly used treatment ' or such other nonsense the thing is filled with.
Let us take CYDY Greatest Claim to Fame - cutting out the fat and the rancid,
let us look at the Meat they say is good to eat.
"All-cause mortality among critically ill patients was 28% (12/43) with leronlimab + SoC
and 37% (7/19) with placebo + SoC
at day 28 (Table4-6).
This
is approximately a 24% relative reduction in mortality."
The numbers are Tiny Tiny -- such that
ONE patient JUST ONE out of 19 makes a difference.
6/19 in the placebo group would have been 31.5%,
Which when you consider 19 patients its simply NOT different from 28 %
If the whole improvement comes down to one patient, it's pretty much impossible to rule out chance.
This is a nothing. An absolute nothing.
And the trial has to be redone with new patients and new endpoints.
NOW add in the claim they will fill this trial in months ?
Seems highly unlikely.
1.SUMMER is coming - we had a big reduction last summer
2. COMPETITION is everywhere - people have choices
3. VACCINES are taken by a high portion of the population
4. SOC changed Standard of Care changed - you are getting a lot less Critical
Each of the 4 items contributes to a reduced critical patient count.
So Good Luck.
$ .85 -===> the price currently ( $2.1600 ) gives the CYDY company a 1.3 billion market cap
they are worth around Maybe Maybe (many other better companies with greater pipelines are valued at ) $ 500 million.
ADD IN:
5. They need money desperately - they do not have money to do more trials
6. The insiders are apparently selling, removing the legends from the restricted shares
7. They already filed an S-3 to sell up to $ 200,000,000 worth of shares - filed on March 03.
So ADD UP 1 - 7:
$ .85 is a very reasonable and rational estimate of the price in 3 months or less ( should be now ).
xxx.
x.
x.
You better see if Kygromax has some extra shirts
This may be painful, wow CYDY selling $ 200,000,000 worth in shares
and warrants
and/or Selling 181 MILLION in restricted shares ?
https://www.sec.gov/Archives/edgar/data/0001175680/000119312521067849/d435677ds3.htm
Ouch, not looking good.
xxx.
xx.
x.
Trade4life
Message in reply to:
I loaded up here at $2.20....was going to wait til $2 but whatever.,...went from 40K shares to 100K shares.
CYDY FILED ON MARCH 03, 2021 TO SELL $ 200,000,000 Worth Of Shares
Don't forget as you watch the price
CYDY Filed on March 03, 2021
To SELL $ 200,000,000 worth of shares and warrants
*** Are some of those 13 Million warrants they want to sell Mrs. Kelly's ???
https://www.sec.gov/Archives/edgar/data/0001175680/000119312521067849/d435677ds3.htm
•
a base prospectus that covers the offering, issuance and sale of such indeterminate number of shares of the registrant’s common stock, preferred stock, warrants, overallotment purchase rights, debt securities, rights and units, which together shall have an aggregate initial offering price not to exceed $200,000,000; and
•
a prospectus supplement that, together with the accompanying base prospectus, covers up to 13,619,223 shares of the registrant’s common stock that are issuable upon the exercise of previously issued and outstanding warrants of the registrant.
The base prospectus immediately follows this explanatory note. The specific terms of any securities to be offered pursuant to the base prospectus will be specified in a prospectus supplement to the base prospectus. The prospectus supplement relating to the 13,619,223 shares of common stock issuable upon the exercise of outstanding warrants immediately and sequentially follows the base prospectus. The 13,619,223 shares of common stock that may be offered, issued and sold pursuant to that prospectus supplement are included in the $200,000,000 of securities that may be offered, issued and sold by the registrant under the base prospectus.
CYDY NEEDS YOUR HELP - CALLING ALL LOYAL SHAREHOLDERS
I understand that CYDY Insiders may need to get rid of 181 Million Shares. These are restricted shares that usually cannot be sold, but CYDY is apparently working on removing the restrictions ( see CYDY Job advertisement below ) so they could be immediately sold. but they may need time to remove all the legends so restricted shares may be sold immediately.
Please Support the Company Insiders if/as they sell. CYDY Needs YOU.
Given todays price and activity maybe they already started dumping these shares. CYDY Insiders Need Your Money / Need your Support. Please buy their [worthless?] shares.
OTCQB Certification
I, Michael Mulholland, CFO of [CytoDyn Inc.] (“the Company”), certify that:
The data in this chart is as of: August 14, 2020
4. Please provide the following share information as of the latest practicable date:
Restricted Shares (C) 181,280,562
Date: 8/31/2020
Name of Certifying CEO or CFO: Michael D. Mulholland
Title: CFO
Signature: /s/ Michael D. Mulholland
(Digital Signatures should appear as “/s/ [OFFICER NAME]”)
https://backend.otcmarkets.com/otcapi/company/financial-report/256897/content
Do you think they will be able to sell these restricted shares in the upcoming few days ? Or maybe take a week ??
They are apparently working hard at that and need a few days ???
Can the Securities Be Sold Publicly If the Conditions of Rule 144 Have Been Met?
Even if you have met the conditions of Rule 144, you can't sell your restricted securities to the public until you've gotten the legend removed from the certificate. Only a transfer agent can remove a restrictive legend. But the transfer agent won't remove the legend unless you've obtained the consent of the issuer—usually in the form of an opinion letter from the issuer's counsel—that the restrictive legend can be removed.
https://www.sec.gov/reportspubs/investor-publications/investorpubsrule144htm.html
============== The Job maybe filled by now ???
Paralegal
Job Reference:237516631-2
Date Posted:27 February 2021
Recruiter:CytoDyn
Location:Vancouver, Washington
Salary:On Application
Sector:Legal
Job Typeermanent
Job Description
Reports to: General CounselCompensation: Commensurate with experienceHours per week: Full Time
Summary of PositionThe Company is seeking a high-performing paralegal interested in gaining hands-on experience at a publicly traded company assisting with the administration of securities and other tasks. You will have the opportunity to play a key role assisting with the end-to-end administration (issuances, exercises, transfers, etc.) of warrants, RSUs, options, stock subscription agreements and other investor documents.
Additionally, you will assist in the processing of restricted stock legend removal and Rule 144.
This position will interact with outside legal counsel, investors, transfer agent, brokerage firms, and the finance team. You will also assist with the administering of securities and investor related documents for execution via DocuSign.Work StyleAbility to effectively function, prioritize, and execute in a fast-paced, dynamic environment.Flexible, fearless, and excited about your part in our growth.You like to take on new challenges and take the initiative.Proactive resourcefulness and initiative to ask questions coupled with the ability to self-manage.You're willing to help wherever needed.Attention to detail and strong organizational skillsDrive to do what it takes to ensure the job is done.A learner with a mindset centered around continuous improvement.Thrive operating in a rapid growth environment.Expert at applying past relevant experiences to define, create and implement best practices.QualificationsExperience with publicly traded companies.
Good understanding of securities law, restricted stock, SEC registration statements, and Rule 144, or strong willingness to learn.
General understanding of SOX 404 and implications of following internal controls and processes.
Ability to establish priorities, meet deadlines, multi-task, work independently, and execute objectives with minimal supervision.Excellent teamwork and collaboration skills.Proficient in Microsoft Office.Good sense of humor.
BenefitsSalary commensurate with experienceStock option compensationPTOCompany holidays401(k) plan with 3% safe harbor contribution after 90 days of employment.100% company paid medical/dental benefits for employees and all dependents.Flexible Spending Account ("FSA" allowing employee to set aside pre-tax wages for medical costs.Company-paid parking in onsite parking garage.
NEW PHASE III TRIAL INITIATED MARCH 5 = GREAT NEWS !!!!
Leronlimab may have found it's best use yet !!
.
Indication Hemorrhoids
Enrollment All Share Holders = Open Enrollment
Enrollment Initiated March 05, 2021
Link Provided:
www.clinicalfailures.com
or See Website www.dataminepumpandsell.com
If anyone made any money here shorting - perhaps they would consider a charitable donation = kygromax yes you too
Please contribute what you can:
www.shirtsforshareholders.com
Shirts preferably washed and folded.
But probably at this point, any shirt would do.
Thank you.
xxx.
xx.
x.
Market Cap CYDY = Still = 1.51 Billion
Even if you are a believer -
no approved product
no sales
having to redo a trial(s)
never obtained an approved product
and screwed up the BLA on the HIV since 2018
No Assets ( Do You WATCH the Videos - CEO is in an office
with bare walls with a file cabinet and a " paper " picture
of a Cytodyn logo on the wall )
Plenty of Debt
In Desperate Need of refinancing / money
to pay for all these trials they keep chirping about
And to re-do the covid trial - and to re-do the HIV trial
Value = 500 million At Best = At Best
That would cut the price down by 2/3
Valuation per share $ .85
This is an $ .85 per share company IMHO
[ See you in six months at $ .85
chirping about Corona Virus results that they are hoping for
And how they almost have the HIV BLA ready to file
data just needs a few more tweeks ]
Good Luck to All.
Time will Tell.
Let us hope, for the patients and their families, that they actually find a drug that works !!
God Bless Them.
xxx.
xx.
x.
MISIU KNOWS --- NO ONE GOT OUT OF THE HOSPITAL EARLIER
EVEN IN THE GREATER THAN 65 AGE GROUP
CHECK THE CHARTS/DATA
https://www.sec.gov/Archives/edgar/data/0001175680/000119312521073448/d145217dex991.htm
GREATER THAN 65 AGE
Median Days in Hospital 41 days Leronlimab 42 days Placebo
EQUAL OR LESS THAN AGE 65
Median Days in Hospital 11 days Leronlimab 11 days placebo
Table 4-32: Summary of Length of Hospital Stay (Days), > 65 years, mITT Population
Leronlimab 700 mg Placebo P-Value [1]
Category
Statistic
N=88 N=29
n 88 29
Length of Hospital Stay (Days)
Mean (SD) 28.0 (15.9) 31.1 (14.6)
Median 41.0 42.0 0.3266
Min-Max 2.0 - 43.0 6.0 - 43.0
Note: Based on the number of subjects in the mITT population and treatment group (N).
[1] p-value is from the rank-ANCOVA model adjusted for stratification factor.
Note: No imputation performed for missing data less than 10%.
Table 4-33: Summary of Length of Hospital Stay (Days), £ 65 years, mITT Population
Leronlimab 700 mg Placebo P-Value [1]
Category
Statistic
N=171 N=96
n 171 96
Length of Hospital Stay (Days)
Mean (SD) 18.0 (14.8) 18.4 (15.7)
Median 11.0 11.0 0.5868
Min-Max 1.0 - 45.0 1.0 - 46.0
Note: Based on the number of subjects in the mITT population and treatment group (N).
[1] p-value is from the rank-ANCOVA model adjusted for stratification factor.
Note: No imputation performed for missing data less than 10%.