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His wife works while he sits down in the basement playing video games wearing his " I coulda been a Contender " Tshirt from 1986.
All the while, silently muttering to himself repeatedly "forgot the frikkin cathode " and drooling on his 20 year old chihuahua named Derek.
Shorts are about to become Cytodyn Rocket Fuel.
I want to thank the shorts for 2 things.
1- Cheaper Shares
2- A big boost next week.
Repeat this over and over CD10 was a failure, no EINDs, they are hiding, CD10 was a failure , videos, $100 dollars decades ago.
They will fill enrollment very quickly as they have more willing participants than they do open slots.
Don't Blink !
So he left MESO and then it failed its Covid trial . Hmm, maybe he recognized an issue earlier on.
He left and went to a company that possibly will hit lots of home runs with his help.
Sounds like a really smart guy.
Actually , hearing stories about how guys in the C-Suite rapidly respond to individual requests for Leronlimab they take the lifesaving aspect pretty seriously.
They also jumped on the EINDs and filed the protocols for Open label extension during the holidays, as soon as the enrollment period ended. Again trying to keep the flow of Leronlimab flowing while waiting on results. Now keep in mind that if the doctors were not requesting they wouldn't need to do this.
If they successfully sell $1 Billion dollars worth of Leronlimab in March, I'm not gonna begrudge them some milestone option grants.
As I said in another post, they thought this was all about making people better and saving lives by keeping patients from progressing to the more severe and critical stages.
The fact that the FDA did not recommend they apply for an EUA was that the FDA already had their " Golden Child" Remdesivir renamed and ready to go for mild to moderate.
Of course WHO outed that little falsehood and poor uptake by doctors put paid to the fact.
That's because they did not fail CD10.
They expected, naively, that the FDA was concerned with saving lives. And that the improvements in patients that was seen would get an EUA.
Normally PhaseII trials do not go and get approved to treat anybody for anything, they are a step to creating the endpoints for a Phase III.
I remember a post indicating that CD10 failed and the proof is that Leronlimab was not approved to EINDs after CD10 was done.
And Yet.
CD12 has EINDs and OLE and is also hailed as a failure.
There seems to be a pattern here.
Except for the Fact that the CD10 results NEWS2 improvements indicate that the story will have a different ending.
What CD10 did that gives Longs confidence was that it showed Leronlimab worked better and showed very good improvement over Placebo when patients were at a point that they were gonna get sicker.
The EINds showed it helps with the sickest patients.
CD12 was the Trial for the people in between CD10 and the EINDs.
The expectation that you posted has a very good chance of not happening.
Yeah, with all of the green energy enthusiasm out there, you would think D'Couto would be trying to get traction for the company.
This is probably the most telling thing, they got nothing.
Or.... D'Coutos investors from 2017 and later are wanting to play "whack a Mole" with him when he pops his head up.
It was telling, that the XNRGI website Team page showed what looked like some heavy weight guys from the Fuel Cell and Battery industries, and they stayed on the page maybe 6 months.
So it seems the smart guys. saw XNRGI for what it was and promptly left.
Yup, Look at Merck's Keytruda it is a blockbuster drug that I think earned them 7 billion in 2018, and forecast to earn over 20 billion/year by 2025.
Those weren't illegal trades either cause he knows those guys.
Not just the mask mandate, all businesses in Texas will be allowed to open and all social distancing rules overturned.
That will be an interesting lab experiment.
Spring Break is coming up, I am sure many will go to Florida which if I remember correctly has the UK variant spreading.
By May the percentage of unvaccinated folks exposed to the UK variant will be considerable.
It seems there might be demand for Leronlimab for a while.
I am just speculating that if and when schools open up, the students are the vector for spread back into individual homes because the schools are the central meeting place.
Students are a younger population and get less sever in most cases, howver they can be exposed and take it back home to mom and dad and grandma and granpa.
In the case of small towns, all students congregate at schools and go back home, no other place is as centralized as a small town school. In larger metros it is no different but worse.
The most centralized point at my school when I was in public school ? The cafeteria. We had two different lunch periods to accommodate the number of students. Its difficult to social distance when time constrained for lunch.
Its always a possiblity.
But if we are to talk about possibilities, we also have to talk about.
They could sell to Countries that do not follow the US FDA. And no Bankruptcy.
They could possible find financing to buy them another year and if Longhauler trial is successful sell there.
or
Get financing to work basket Trials and if successful there sell the inventory for that. Very promising results so far.
or
Get financing and complete HIV BLA and go commercial there.
See, COVID19 is not the end-all for Cytodyn. It really is a surprise first step.
I look at it this way, if I lose, it may be temporary and I can withstand that, If I WIN, it will be HUGE !
Who are these guys ? Why did Cytodyn sign a supply services agreement with them ?
Was this a first step in securing manufacturing in the US ? This would have made sense in having a domestic manufacturing partner in order to simplify FDA inspections for domestically produced and consumed Leronlimab.
https://www.prnewswire.com/in/news-releases/ajinomoto-bio-pharma-services-announces-manufacturing-partnership-with-cytodyn-for-drug-product-used-in-covid-19-clinical-trials-883684839.html
" About Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India. "
Key here is the United States, no excuse for not being able to inspect facilities.
Thanks misiu ! I forgot to consider the negative side effects, that make it worse than saline.
Over 500,000 deaths and now everybody acting like COVID is over.
My brother was telling me the other day that his son's high school was going back to virtual due to over 14 teachers including substitutes tested positive for Covid.
The biggest problem in the US is that every time the virus starts to recede they start opening up and cases start increasing. This thermostat approach is what will allow the virus to find the un-vaccinated as the spread will happen in the schools and they will take it back home.
Vaccinated will avoid getting critically ill but the un-vaccinated will be in the same boat as today, a flip of a coin between no serious illness and death.
Not really, because if they did not fail, then they will pretty much be able to immediately sell all of the manufactured Leronlimab.
If that happens, they will immediately be at a point in product sales that most successful companies take years to achieve.
Just like turning on a light switch.
Actually they were pretty specific in their requirements about what they want to have in terms of experience and knowledge, not something a paralegal graduate just has.
What C-Suite doesn't self enrich themselves ? This is the main reason for the last few years of stock market rally.
Stock buybacks happened so that insiders could sell.
That is the reason this company is hiring a paralegal. To create a compensation program that follows the rules.
Not a flop. Remember this was a Phase 2 trial, in which a lot of learning happens.
At Day 3 there was a marked difference between the Leronlimab and the control group. By day 14 the Leronlimab and control must not have been different enough. The control got better just as the Leronlimab got better.
Not a flop as Leronlimab group got better sooner.
NEWS2 scores which a a predictor of progression to severe were much better in the Leronlimab arm, once again not a flop.
If 67% of people in the US had not progressed from Moderate to severe we would have had a lot less deaths in the US due to Covid.
This is where the FDA deferred to Big Pharma. They told CYDY to proceed with Phase 3 S/C trial and would not recommend Leronlimab for Mild to Moderate patients because they would get better on their own. Then within a short time frame were recommending Remdesivir and we all know how well that worked.
It works much like Saline.
So the progressions continued in many, and many died as they progressed to Severe and then to critical and then to death.
Yeah, if I was that committee that made that decision, I would really want some time to figure out how to spin those decisions to the powers that be, and the public, and want Cytodyn quiet as church mice while I figure it out.
That's right ! Is it " I am eager to win " or " I am eager to lose " ?
I don't know anyone who is eager to lose.
That's a generality, and you did not specify whether this was a Covid Patient or not.
I know of one poster here who fought to get Leronlomab and had issues getting the doctor to buy off on treatment.
I am not asking about a person with both feet literally in the grave, that is the difference between being too far gone to help, and Leronlimab not helping and a person going to critical.
See, that is what is put forth in the negative light every time, vagueness and smoke. Nothing definitive.
Thank You !
The Standard of Care has resulted in approximately 500,000 deaths in the US alone.
Sounds to me like Saline as Standard Of Care might have been even worse than 500,000 deaths.
I still have not been provided with any Death statistics for Covid patients treated with Leronlimab.
I got a link to the trial site at Clinicaltrials.gov which shows the trial structure but no data. There was a hearty claim of failure with it but unfortunately no data.
So basically the DATA which is used to decide SUCCESS or FAILURE is still not available.
I do understand that current investors are using past performance in EINDs as a basis for investing and it seems the most vocal Doctors are those who have used Leronlimab to actually treat Covid patients.
Can someone point me to a Doctor who was very disappointed in the performance of Leronlimab while treating COVID19 ?
With all of the supposed failure, there have to be some disappointed Doctors out there, right ?
Where is the part where people treated with Leronlomab died ?
The Trial document does show that as the primary endpoints but no numbers.
To make statement of failure without numbers of deaths on the placebo and on Leronlomab is not facts.
Pretty sure I asked for facts.
A link to a different trial in the UK has no bearing on CD12.
THE EINDs and the Open Label Extension were opened up and require the same criteria as CD12. That is what he is posting about. After the FDA has received the CD12 data they have not shut it down.
The reasoning here is that if the data from CD12 was bad, the EINDs and the Open Label Extension related to CD12 would be shut down, but they have not been shut down.
This looks like there will be a smooth usage transition from EIND and OLE to EUA.
Show me some data that shows where Leronlimab treated patients got worse after they were treated.
Based on the EINDs that happened last Spring I agree with you that the data has to be spectacular.
Nothing published anywhere to show Covid-19 patients got worse on Leronlomab.
Some physicians at 18 hospitals were doing just that . And while the trials are blinded , physicians are not blind. They can see a group of people getting shots and not know who got what.
However they will notice that some get better in a much more rapid fashion. Do you honestly think they will see someone get better more quickly than they are used to and surmise they got the placebo. uhhm no, they will think...he got the good stuff.
After the trial was no longer enrolling and they got the EINDs and then the Extension , they knew who was getting Leronlomab, because everybody getting a shot was getting Leronlomab.
After that it's just a shot and then observation.
Those doctors have a very good idea as to whether it works or not.
Please tell me how you know the results of the Primary and secondary endpoints in the CD10 trial if the results were not posted on the Trial site ?
If you have a source please share.
The claim has been made here that Leronlimab is as effective as Saline in treating Covid19. Constant repetition of failure.
In the patient journey you can take a lot of people lets say 500,000 in the US who were fine then went to mild, then moderate, then severe and finally to critical covid with complications and finally death.
How many Covid19 sufferers can be pointed to that went to mild, had leronlimab and proceeded on to the next stage then death ?
How many were moderate and had Leronlimab and went on to the next stage then death ?
How many were severe and had Leronlimab and went on the the next stage then death ?
As far as I have read none of the above have happened and yet it has happened with the standard of care very many times.
Deaths reported in the EINDs were end stage people described as being at deaths door and given Leronlimab as a last ditch effort.
Is there any case where even anecdotally the shorts can point to a person was treated with Leronlimab and proceeded to get worse ? in my mind that is a failure, where no effect such as that from saline is observed.
Honestly, I am anxious to hear any individual examples of failures. There are many anecdotal examples of successes. Where are the anecdotes of failure ?
I seriously doubt that, but as you are selling I will be buying.
Henrik said it very simply.
“It’s the kind of technology where, when you feel like you’re 90 percent there, you’re almost there, until you realize the last 10 percent is much more difficult than the first 90,” he said. “So we have completely dropped solid-state batteries at this point in time because we just don’t see it materializing.”
As for XNRGI who Knows ? They claimed a lot of things and as always poof ! Nothing but silence.
A lot of companies that were making noise in 2016,2017,2018 are all quiet as church mice right now.
Has anyone reached out to D'Couto ? I irritated him years ago so no responses to me. A friend of mine who has reached out in the past and gotten responses gave up on this also.
I suppose that in your scenario the world is vaccinated by the end of April.
Uhh no.
In my scenario, a larger percentage of the US population gets vaccinated, they open everything up, the new variants really start moving and unfortunately at that point in time approx 30% to 40% of the population will still be unvaccinated and it will spread through them like wild fire.
Only it will be the more dangerous variants.
Originally Covid started with 1 person having it , to what we have now.
Then consider the world, many Nations do not have hope of widespread vaccination for a year or two
As sad as it is, there will be plenty of opportunity for Leronlimab to prove itself.
The US and other advanced Nations will open up and the virus will get into the cracks where the anti-vaxxers reside, 1% of the US population is over 3 million.
If Leronlimab gets US FDA EUA, the rest of the world will follow.
Then the long hauler opportunity will overlap with that, creating more demand. This will overlap into HIV use and demand uptake which will be ongoing and overlap into Cancer.
Covid is just the jumpstart for CYDY demand and therefore earnings and the first sale will buy them financial independence. After that, it just becomes a money factory that saves lives. That is my opinion and I'm sticking to it.
It's simple, USA FDA EUA = WORLDWIDE OPPORTUNITY.
Yeah but because it was not a primary endpoint, meaning it was not declared at the onset CD 10 has been declared a failure.
Not by anybody with medical credentials, not by anybody associated with a medical regulatory authority, but by a bunch of stock shorters ! HA !
What some do not understand, is that longs are looking for indications that Leronlimab is effective against covid.
CD 10 helped the Cytodyn team learn more about Leronlimab vs Covid. They started with the EINDs , completed the CD 10 and the CD12 trials and will have a more complete picture as they go through the long hauler trial.
Nothing bad about any of that.
I do thank NP for more time to load up on more CYDY stock, I also thank the short selling cabal for helping me buy it cheaper. I am still averaging up, but in the end a dollar a share is not too bad.
Since I do not know if the CMC module of the BLA that Cytodyn previously filed for HIV was included, the FDA might already have that.
It really depends on whether they filed a " rolling BLA" and also what modules were filed. At the very least they should have some of that information already prepped, especially if they have over 300,000 vials ready.
My opinion is the FDA wanted the information as soon as they unblinded due to requests after full enrollment. Now they have requested a deeper look at top line and that is the delay.
Depending on what the "sneak peak" showed , they may also be haggling about the limited supply and how much the US gets,it is very possible they get an EUA only for the sickest patients, no mild no moderate only critical.
As long as they get to sell their product, increased production and the fact that they begin revenue generation is the key, first to survival and then shortly to dominance.
OMG ! He Paid bills ! Now if that isn't the hallmark of a crook I don't what is.
If he had left the bills and bought a yacht or a mansion in Florida or in the Bahamas that would be more indicative of a crook.
Taking care of business both on the personal and professional side is not a bad thing.
Using personal moneys to run a publicly traded corporation is bad business.
They were not exercised, they were granted. They will vest 6.25 % a year.
Unwritten. But most likely they will get immediately vested in case of a buyout.
Bullish. Yes. They are setting themselves up to cash in. If you were upper management what would you pick ?
Vest between now and 2030 or sell the company and get those millions up front ?
I think this company will be sold within a year
Yes, using Google Pump and Dump logic, CD12 is a winner, EINDs were re-instated using CD12 criteria at any US Hospital that requests it.
CD12 criteria used for OLE at CD12 participating Hospitals. PLus, no more placebo, only Leronlimab.
None of the new EIND results published, no new anecdotes so there must be NDAs in place. For OLE same, no numbers or anecdotes.
I am sure the results on the EINDs and OLE are being counted yet not released as this would give hint of CD12 success. Yet the OLE and EINDs are not being halted.
Do you pay attention to any other late stage biotechs ?
I am in one that is very promising, finished their Phase 3 in summer of 2019. Had meetings with the FDA at every turn, submitted 3/4 of a rolling BLA in December 2019, went through a very strict manufacturing portion and finished submitting the BLA in December of 2020 just as they forecast.
They have a PDUFA date in August.
That's 2 years from completion of the Phase 3 to the PDUFA.
a few weeks is nothing and is motivated most likely by the Pandemic.
Yup, and since as everyone says, you can see whether they achieved the mortality endpoint in a glance, they are most likely wanting a deeper look. This means a top line report.
Too many people confused ( supposedly ) about the extra time. Get rough data which is excellent and then request top line. So then extra time needed.
At the same time they may be inquiring as to the ability of Cytodyn to meet demand. Not just asking a question, but wanting to see a plan for manufacturing AND distribution.
A few weeks is nothing for a company to grow from a seed into a Sequoya .
If the data was bad, there would be no discussions with any regulatory body.
If the trial failed they would get shut down on Covid19 immediately.
I'm gonna sell some other stocks today , hopefully the price will stay low. End of this week I throw more at this.
Next week I get another cash injection so I can buy more.