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Unfortunately this is what NP does.
He Hypes a potential, then walks away.
He seems to be looking for a fast route, then when it doesn't pan out goes to the next fast route and has wasted a lot of time.
He currently has distribution deals with Chiral, BIOMM, now these guys.
But no sales...sales require regulatory approval which he can't seem to get, anywhere, otherwise he would have announced.
Instead he announces more fluff..a distributor with no sales....so can't distribute.
However, he may be able to sell more stock if he can sell the promise of future sales.
Everything maybe hinging on the Brazil trials which have not even started yet.
jmo
This is vapor. They announce a distribution agreement with a company to sell LL in a country where we once again are waiting on regulatory approval.
NP always putting the cart before the horse.
Did Cytodyn quietly walk away from the Philippines ?
This is like saying you bought a plane ticket to India , but you don't have citizenship in any Country, so you can't get a passport. But one of these days....
Jmo
I was in a stock last summer MBRX Moleculin Biotech that was also looking at a 2-DG treatment for Covid19.
They have a Prodrug called WP1122 that is a precursor to 2-DG and this supposedly enables it to stay in the body longer and be absorbed more completely. It was developed for applications in Cancer at MD Anderson.
They are planning a Phase 1 trial with the MHRA this summer. So they are pretty far out in the Trial stage.
Their in-vitro studies were showing a very high blockage rate ( 100% ) for Covid cell replication.
They theorize this process will work with all Corona Viruses, Rhinovirus, Herpes Virus. If true, they have a cure for the common cold.
I hope you are correct.
NP calling out Paulson in the latest Proactive then the 8 K showed Fife was strike 1. This was an intentional misdirection on NP's part.
The Canada Interim Order submission PR saying " The remaining portion will be filed very soon ' was Strike 2. Another misdirection , this time in a PR.
The Philippines CSP, LL quantities sold if at all , the mysterious 28 and EUA application are up in the air and may be a base hit, home run or Strike 3 for me.
Jmo
I agree, I finally realized that they have taken the CMC module information and since that is manufacturing data which really they don't control , they submit and claim they have started the process.
The fail point for CYDY is the clinical portion. It's possible all the EUA applications require results and passing P-Value which they do not have.
It's possible they are using these to kick the can down the road until they can get a successful trial, however that is way down the road, if ever.
This is why I saw the CSP and revenue from that as important, yet they went completely silent on that and skipped to EUA which I do not believe they will even complete the application for, much less receive the EUA.
If they can't get paid, then they definitely will not donate an expensive amount of LL to the Philippines , which may be what the Philippines FDA is pushing for.
Jmo
Great news, the only problem is Cytodyn .
They haven't EVER completed an application for any EUA, or a BLA or an IO anywhere ever at any time.
The Cytodyn team seems to specialize in Trials that don't achieve endpoints, they Start Filings and PR the snot out of that and have never completed one
So...nothing will be sped up for them since they do not have an application in yet.
Jmo
Yeah, a lot of balls in the air.
That is the exact opposite of "Focus"
They talked about the Philippines in Dec 2020...nothing then, shifted to Canada after the CD12 results released ( Not completely successful) and put the Canadian Interim order as a quicker possibility.
Didn't happen, and now Canada on the back burner after Hyping the CMC filing. " Its the hardest part " now dropped the ball on the easier portion. Most likely wont happen. Waiting on CD16/CD17 results if ever.
Then back to the Philippines where the first CSP was hyped. Then 28 CSPs hyped then nothing. We are waiting on news on the 28 and waiting.
Now they claim CSP treatments for 100 patients at all Hospitals and up to 1000 Hospitals, but instead of releasing actual numbers and amount of LL shipped, sold to be stored in those Hospitals for CSP. Instead of announcing the amount earned, they don't release any info on that either.
Instead, they now begin talking about an EUA, oh but it will have to wait.
Now people are talking about India, and Malaysia.
As far as what the company has told us, we had 3 people in the Philippines treated, CSP #1, the ex-President and the guy on Sunday. 3 CONFIRMED that's it.
Now the company has moved on to other things to focus on or actually to not focus on.
Message to NP and SK and others.
PICK ONE THING...START TO FINISH...
It seems to me CYTODYN the company has a problem with Attention Deficit Disorder.
ONE THING ! COMPLETE IT ! ITS NOT AN IMPOSSIBILITY ! ITS ACTUALLY WHAT PEOPLE DO IN THE WORLD.
jmo
Probably and at restaurants when ordering food ," have you heard of NP ? He's a bad CEO "
Just spreading the word all over the world.
Is this in search of cheap shares? I don't think so because thr narrative never changes.
Former management or a relative of them. Very possible.
Does not matter anti Cytodyn no matter what the wrapping.
Oh well, everyone is entitled to their opinions.
Jmo
HH yes, it is what's needed to give irrefutable evidence that LL works .
We won't be needing the shelf pretty soon, revenues will handle all financial needs.
In the Philippines it started not long ago with 1 patient. Some were "laughing".
Then it was 1 hospital ( 28 patients ) , some were still laughing
Now we have CSP approved for 100 patients per hospital and no limitations on the number of hospitals. So we have possible up to 1000 hospitals.
This is called exponential growth.
Pretty soon in the Covid treatment world enough doctors will see and believe the results and we will see a Paradigm Shift in doctors beliefs about LL.
This will open their minds to accepting the other phenomenal data that CYDY generates with future trials in Longhaulers, Nash and Cancer.
We are literally at the cusp. Some are still laughing. The difference between laughing and crying isnt very big.
Jmo
Calstang66,
I seem to remember NP mentioning a Trial in India on the last Proactive interview, yet nothing was mentioned in the last CC.
I wonder if this is due to negotiations ongoing with an entity for India trial, EUA or Partnership.
This very powerful statistic will be reproduced and proven in a much larger population in the next 3 months.
When those trials in Brazil show these same results in a larger patient population there will be no question. No devil's advocate logic to hide behind for the US FDA or the US Medical systems administrators and doctors.
The next Quarter will definitely be interesting.
Probably nothing as sad as that is.
I think that NP is banking on Starting the Brazil Trial asap. Enrolling the 40% in a months time and having such strong results at interim that they stop the trial, but that's just my opinion.
He made a comment at the last CC about the Severe Trial moving faster than the critical that did not make sense, since they were estimating an interim in the August time frame for the smaller critical trial. They estimated an interim in the October/November time frame for severe. I replayed it multiple times because It did not make sense to me.
For Severe:
45 Hospitals - 10 people per hospital. That's 450 people. Can they enroll 10 people in a month per hospital ? I would say yes. Why would they take 3 months to enroll 400 people ?
1 Month to enroll 40%, 1 month to treat, at 2 months max for Last injection. Pause trial and 1 month for interim. If they can get the same 82% numbers at interim, that will stop the trial due to knowingly hurting the placebo population.
EUA at 4 months vs 7 months how many people saved in Brazil ?
jmho
I'm sure someone is posting many other things about LL and Cytodyn and it's management that may not be facts.
That's right Mountain Man.
If you watch National News or 60 Minutes the commercials are almost entirely Pharma Drug commercials.
Big Pharma is the biggest advertiser of the major networks. They will not ever bite the hand that feeds them.
Even when LL works and saves a life, the excuse that it is not known if LL had anything to do with the recovery is given . The crutch of Trial with phase 3 is thrown out as being needed to prove it has an effect .
I think these next trials in Brazil will shut them all up and prove it is the "Miracle Molecule "
Half of Cytodyn's problem is it's supposed investors who seem more interested in causing discontent in the shareholder ranks.
He gets quiet people cry.
He speaks people cry.
Seems to me that some supposed investors who like to shoot their investment in the foot, should find an investment that they actually believe in.
You mean he can count the number of days that have passed since the last call ?
Amazing !
So you think he hired the two former Merck employees not for trials but for anecdotes ?
CD16, CD17, CD18 will be about anecdotes ?
A company looking to buyout another company or to partner with a company looks at it's asset and intellectual property that can either benefit them.
In a buyout they can flush the employees so it's not a big consideration.
In a partnership it would be a consideration and would affect negotiations as to control of the partnered indication.
You are correct on the anti NP rhetoric , they want him gone in order to get Cytodyn for less. He is getting recognition for LL on an international scale and will keep getting the value increased. The prospects of a buyout or partnerships will keep increasing.
I really enjoy the varying narratives of short sellers on Cytodyn.
A person who speaks publicly about Leronlimab in a positive way must not own the stock or it's pumping.
On the other hand management must buy stock to show they believe in the product and the company.
I find it interesting that some post nonsense here.
Where has Cytodyn set an expectation of the FDA to do anything with anecdotal information ?
NP has said the FDA said no, need more trials. The only ones coming up with creative and fictional ways to get approval are supposed shareholders.
Cytodyn is waiting on the FDA to approve protocols on CD16. They will will enroll in other Countries where uptake will be. Faster but the trial will still be on the FDA website.
Long shareholders create unreal expectations and this is somehow attributed to Cytodyn ?
Cytodyn had hired 2 new employees away from Merck who are specialists at Clinical trials, in what way is that indicative of Cytodyn sitting still ?
Seriously there is a never ending tirade of commenting about how current management has no experience running trials, they hire some experienced people from one of the Biggest pharma companies in the world and this is ignored or purposefully misinterpreted as a buyout indicator.
Jmo
There are many people here who would not want that
Private placements where I have seen them are a stock purchase.
They are a stock purchase directly from the company usually through the stock transfer agent.
It's not a stock grant such as for services rendered as some here insinuate.
This can happen when someone does not have a stock trading account but wants to invest.
It's quite funny that the opinion is put out for the executive team to buy shares if they believe in the company.
Yet Recknor bought after being treated with LL, he became a believer and bought in then joined the team
Randy became a believer and bought stock and is supporting the team .
So don't buy stock and are criticized, buy stock and are criticized
If some certain people had a coin and we're flipping it, I am sure they would call out Heads and Cytodyn loses or Tails and Cytodyn Loses
Yes 166% improvement over SOC on NEWS2 scores, meaning the patients did not progress to the next stage
This is really where it should have been applied.
I wouldn't call it failure and I wouldn't call it saline. But then I also do not have any interest in CYDY failing and getting taken over for pennies per share.
They are not really predictions. He throws out dates and phrases that mean nothing and then people assign their own meaning to it.
The bad thing is that when nothing that swings the stock price happens, everybody gets mad at NP.
Its the most bizarre behavior.
I was referring to the whole trial not the Critical. Since we were speaking to the Trial results as a failure.
The bigger advantage would be the younger in the severe as they have a stronger natural immune system than the older patients and that would be where the biggest change to the total trial results would be.
But lets talk about the Critical.
Critical was total of 62 Patients.
65 and less was total of 44.
29 in LL + SOC resulting in 3 deaths for 10%
15 in Placebo + SOC resulting in 4 deaths for 27%
We know that CDC says 8 of 10 deaths due to Covid19 are 65 and over. That would suggest that 2 of 10 are under 65 for 20%.
You could suggest that LL fared better due to more 65 and under but they still performed twice as well as the average touted by the CDC.
Over 65 LL still performed better.
65% for LL vs 75% placebo and like I said, that is with 1/2 treatment.
CDC touts over 65 as 80% of deaths. LL was at 65% at 2 weeks of treatment in a 4 week trial. At 14 days while Leronlimab still circulating in the body was at 18% mortality.
80% Mortality or 18% mortality ?
JMO
CD12 was not an abject failure. It did not meet it's endpoint. In other words the goal was not met. But there are a couple of reasons for that.
It was a double blind randomized trial, so lets say that the way that the patient populations ended up was random and chance went against Leronlimab.
The difference in the age stratification that ended up happening meant that the Placebo arm without any other considerations was given a headstart due to the naturally lower mortality rate of younger patients vs older patients. The intended 2:1 ratio of under 65 ended up as 3:1.
Leronlimab plus SOC had to be better than the placebo plus SOC just to get to an equal mortality rate. So to improve on that means that yes, Leronlimab worked but technically did not meet the p-value and most likely because of Leronlimab being held to 2 doses. So this was a 4 week trial with only 2 weeks of treatment.
The next Trials should be home runs due to the Cytodyn team now being aware of the pitfalls of simplistic Trial design.
Just fixing the age stratification and number of dosages should net the required P-values. Going with time to release from the Hospital should be easier than mortality also. They should go with criteria that the CD12 showed they do better at.
They do need to take care to run the Trials in Brazil and India to FDA standards in order to be able to use the data for EUA and/or Full Acceptance in the US.
jmo
This must really cause a pucker factor in the short sellers and BPs executives, although I dont know why, since these patients are receiving LL after Big Pharma's best and most expensive treatments fail.
That might be because the LL arm was LL plus SOC while the Placebo arm was Placebo plus SOC.
The common denominator in both arms was SOC. If the SAE's were the same then that would suggest that Leronlimab did not add SAE's.
Its very simple to see.
The reason Dr Patterson is using the drugs he is using currently for LH Is that he only has the choice of what currently has an FDA approval at this time.
Since LL does not have an FDA approval it cannot be considered. The EINDs and OLE cannot be applied to LH as they are use specific. Same criteria as CD12.
I'm sure if LL had an FDA approval he would use that over Maraviroc due to Maraviroc's potential bad side effects.
With this new round of financing and how quickly it happened after the last round, it may be an indication that the latest "talks" with a BP that Cytodyn was in, did not go as well as we hoped.
Perhaps the BP wanted too much for too little and attempted to squeeze NP too hard. To show Cytodyn has options to raise funds, they immediately raised more money.
Next time, the price to buy in will be higher for that BP, if they are even needed.
The other option is that BP wanted Cytodyn to put up more money in support of Trials and then they would then participate.
Either way, earnings in the Philippines will go higher and with success it will continue to increase exponentially eventually engulfing other nations and spreading like, well COVID19.
COVID19 Started with 1.
Leronlimab VS COVID19 started with 1.
jmho
If Leronsaline failed by being better than SOC in any and all categories, what can we say about the the rest of SOC.
We can say 570,000 deaths in the US. That's a lot of failure in the SOC of the most advanced nation in the world. That's a lot of failure in the NIH, CDC, FDA, NIAID there are many organizations that could have made the necessary decisions to save lives in this pandemic.
The OLE running at just under 17% mortality is better than anything else out there at all.
That is patently false.
Leronlimab performed much better on the under 65 age group that were critical.
The critical patients in any age group were benefited by getting Leronlimab.
More would have lived had the FDA allowed them to be treated over the full course of the study instead of only the first half.
Some cannot separate the fact that Leronlimab did not fail at anything.
What the trial data shows is that in the 62 patients which were the worst the placebo plus standard of care could not match LL's benefit.
In the other severe category which had more subjects the Placebo plus SOC still did not perform as well as Leronlimab but performed well enough to deny LL the P-Value.
In all categories LL beat the SOC alone. It just did not beat SOC by a large enough margin
Currently Cytodyn has submitted new protocols for CD16. They are waiting on approval of the protocol from the FDA. This is where the FDA has the potential to exert influence and in the case of CD12 did.
EIND patients a year ago were getting more than 2 injections because they were at deaths door. They were getting what was needed. This is because the treating doctors were trying to save them and not having to follow a trial protocol.
Did he just say " we bagholders " ?
Is he angry about things happening in a stock he doesn't claim to own, but to only short sell ?
Right, and if this were to happen, the same group would be crying about dilution and saying an effective CEO would have waited for more catalysts and a higher stock price to raise money.
There seems to be a common theme from some that always pushes one agenda.
Naw, that lottery money should be used to buy a clue, a conscience, a large bag of empathy for the Covid19 victims.
Maybe a business that does not require one to convince other people to do anything, because there is no talent at that present.