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Yeah but we know Leronlimab is gonna be very successful in this indication once they can get enrolling started again in TNBC.
So you are saying Siegel was a visionary.
Yes, the new dimension they are transported to as molecules of alien excrement will be named the MARGIN CALL DIMENSION.
Large Bank macrophages and T-Lymphocytes will hunt them down and run them through an atomic particle filter that separates what's left of them from their copper valuances ( pennies ).
Wow, Misiu143 that's awesome, hope he reveals his hard work one day. He deserves the respect and kudos for his efforts as do you and others here.
I think some international attention will sway opinion here in the US as to whether to support Cytodyn or not, by some regulatory bodies.
Kgro getting that pucker factor up to P value of 1.50 yup that's 3 digits. I think 150% is high enough for now.
By next weeK it should peak at 5.00 still 3 digits but will be 500%.
Next year with HIV, Covid and Longhaulers that pucker factor will have reached a null singularity and have encompassed all shorts into a brown hole, not a black hole and into a mess of atomic particles which will be used to treat diarrhea at the output site. In alien orifices.
My hope is that nations like Hungary who actually ask for the data can be open minded enough to see the benefit of using LL and buy up the supply.
The US can get to back of the line. They had a chance at this for a year and spurned it, let it go where it will be used.
That's a reference to a pot holiday .
Apparently it is an option.
https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-018-1017-7
51 Patients.
3 Months
18 Hospitals
That definitely know about Leronlimab, that have an Open Label Extension.
That is not even 1 patient per hospital per month.
6 Critical patients when there is no Alternative.
Something is wrong here.
I'm not saying there is something wrong with Leronlimab or with Cytodyn. I'm saying there is something wrong at the hospital administrations and FDA and their relationship with BP most likely.
By my statement in the last post, what I am saying is at these 18 Hospitals what is apparently happening is that the Doctors are hiding behind the technicality that they gave SOC before the patients died.
They did not " go out on a limb " to use LL as a last resort even though they knew it was available through the OLE.
Death before OLE in 18 hospitals ?
Like I said, the ethics issue is a straw man, when a "technicality" is viewed as more important than a life.
While what I wish you are saying were true.
What we are seeing even in the Hospitals that ran Trials with Leronlimab 18 total. The use of Leronlimab at about 4 patients per Hospital average a full 3 months after the OLE was initiated in December 2020.
4 patients in 3 months. Probably less.
What was it ? 6 total critical patients, in 3 months? Even just counting the time after unblinding is pretty pathetic. That is why I say the ethics argument is a straw man. The Doctors at these 18 hospitals are making the decision not to use Leronlimab, for Myself I see a lot of ethics failures here but nobody is talking about that. Why ?
There are many motivations aside from getting patients better in my opinion.
We know there at least 18 doctors, since 18 Hospitals participated in the trials. There actually should be more doctors than that who know about LL in those hospitals. The OLE does not have the onerous paperwork required by EINDs. Yet there was pathetically poor uptake in the OLE.
I agree with you, it seems the choice likely between EUA or CD16/CD17.
With an EUA LL will be more available, however since many doctors do not know about Leronlimab it will not be their choice of Care. This means some people will get LL and some won't.
This is evident even at hospitals where Leronlimab finished the CD12. If this was not true, the OLE numbers would be much higher.
The only difference would be how closely patients are tested, monitored vs patients not in a trial.
That whole ethics argument is a straw man , the only thing that would make it valid is if 100% of critical patients were treated with LL, which we know will never happen.
That's funny, " Get the Placebo and die"
In case you haven't heard , Leronlimab has not been competing against saline.
Leronlimab has been competing against the Standard of Care.
This is the same care patients would receive if there was no trial.
The bet here is whether trial participants who get Leronlimab get better faster than the patients who have received the best care the US medical system can provide.
I don't know how it would look if there was an EUA at the same time as a trial other than the fact that an EUA does not guarantee that all patients will get Leronlomab either. That is all about uptake in the hospitals.
If you want to see the same grouping of Law Firms that are going after Cytodyn it is very easy and very blatant that they have teamed up with a Hedge fund who is short selling.
A similar embattled company like Cytodyn. Just go back about 3 months ago in the PRs and they have a flood of class actions etc and this company put out PRs about the short selling Hedge Fund.
TRQ - A Copper and Gold miner in Mongolia.
https://finance.yahoo.com/news/turquoise-hill-comments-letter-short-142900191.html
https://finance.yahoo.com/news/turquoise-hill-says-odeys-letter-150918103.html
Rosen Law Firm
Gross Law Firm
Zhang Investor Law Firm
Levi and Korsinsky
Pawar Law Group
The Klein Law Firm
Jakubowitz Law Firm
Bragar Eagel and Squire PC
The Schall Law Firm
Kuznicki Law PLLC
Rosen
Law offices of Vincent Wong
Bernstein Liebhard LLP
Kahn Swick and Foti - Former Louisiana AG
Pomerantz Law Firm
Howard G Smith
Bronstein Gewirtz and Grossman
You sure do.
I agree with your view wholeheartedly.
However in this situation Cytodyn is not arguing for a change in the rules. They have done what any company would do with data obtained from a trial.
They have studied and analyzed results to "learn" where the Drug works best. They have constructed new Trial formats to create a test for LL to show its power and effect where they see the best chance of success and approval.
They made a change in adding a new trial protocol for the 65 and over with 1st treatment as an IV with two additional "shots". Once the FDA accepts they will begin.
To use a football analogy, Cytodyn did not make a touchdown, but are trying to kick a field goal. Get some points on the board with the conditional EUA. If the Field Goal is not successful, they will have to try for the touchdown on the next possession which has 2 strategies CD16/CD17.
HH claims the game is over Cytodyn lost and is trying to change the rules. Nope, the fans are screaming at the refs is all that is happening and the game is not over.
Hindsight is always 2020.
Everyone jumps on the "triple digits" when criticizing the CEO. Yes he did, however everyone took it as triple digits ASAP.
Anyone who listened to the last call would have heard SK mention that Covid as an opportunity is small compared to Longhaulers and Longhaulers opportunity is small compared to HIV and Especially Cancer.
In my opinion the difference between these opportunities is a "time opportunity" and a "Numerical opportunity". Covid is now, and an EUA would enable revenue sooner than the other opportunities which will be larger "numerical opportunities".
The current EUA would hasten this if approved.
If not approved, they will have to wait for CD16/CD17. This would result more likely in an opportunity for revenue by summer which is sooner by 9 to 12 months than any other opportunity that they currently have.
The Covid revenue opportunity is a bridge to LH revenue, Both are a bridge to HIV which will then be the bridge to the largest revenue opportunity and is furthest away time wise and includes NASH and Cancer.
When those are realized CYDY will be triple digits. Anyone who expected triple digits by summer was fooling themselves.
Please suggest a therapeutic that works better than Leronlimab for treating critical Covid19 patients.
When you played football if you won by a point you won. You didnt have to win by double the score did you ?
That Redditor wasn't the only one. I checked back thru 2017 and no Cytodyn.
Ha ha, its very difficult to say what other Countries will do.
Leronlimab has a better chance at acceptance for Emergency use in other Countries if it is given that opportunity in the US.
The main reason being that the US is the only place that CYDY has run trials. That is under the auspices of the US FDA.
If CYDY had run trials in their Countries they would look to those results but this was not done.
As for the Philippines, it seems to me that they are waiting on the US FDA and trying to buy time playing games. Sorry but if you cant find 10 people to treat then you don't need 200,000 doses reserved for you. If I was NP I would reduce the amount reserved for the Philippines to 1,000 doses.
Yeah, NP does not ever elaborate on his answers to make things more clear.
This is one reason people don't like him, is that they misunderstand context due to the short terse answers he gives.
This is common with a lot of people for whom English is a second language.
The Conditional EUA if it happens would happen first.
The condition needing to be met would be the additional trials and the success of those trials before the granting of an Unconditional EUA.
In my opinion that is the reason for the two trials. While Cytodyn feels that LL can succeed in both age groups, they are not willing to be the farm on it.
If running just an under 65 trial where they got outstanding results this would eventually lead to an EUA for only that younger population if an unconditional EUA were granted.
Running a separate trial for 65 and over with different treatment options lets them learn how to save more lives, and will give a second treatment group if the results are good enough.
IN the end an EUA is an EUA period. This allows the company to sell LL to hospitals.
IN the last CC NP stated that there were 40 patients treated under OLE.
By now I am sure it is higher.
What I think is very telling is that the doctors who have used LL and seen it work become very engaged in trying to get to where it is available for use in saving lives.
There is not a " no thanks " attitude shown after they use LL.
Well, I would have to say that Mahboob Rahman is currently the person involved with CYDY at this time that has expertise in filing BLAs.
Whatever needs to be fixed and how long it takes is what will have to happen.
A new CEO will not have the expertise that Mahboob does and resetting his work will just add more delay.
Past delay has already happened there is no changing that. Currently NP is concentrating on 1st revenue potential.
Go first where there is a chance to make money to buy more time to make more money.
Pushing the idea that a new CEO would just drop in and be immediately successful rewarding shareholders with wealth is not quite accurate.
A new CEO would want to succeed at "Goals" and want a nice cushion to ensure that. That cushion would come from a nice fat RS. Taking the OS to about 40 to 50 million. That's about a 1 for 16. They would then need to raise lots of money for that cushion. At least 200 million to 300 million and then maybe a partnership with a BP that would cost another 10% to 20% of the company ownership.
I think that a $100 per share price after that kind of action and I might be at where I was when the stock was at $7 dollars per share.
The price of Success for a new CEO who does not currently have skin in the game would come from the current shareholders. Be careful what you wish for.
It's almost like those law firms are in a race against time.
Gee , what could possibly happen to CYDY in the near future that all these lawyers would be trying to pile on right now ?
A lot of effort to either scare away existing investors or prospective investors.
The only problem is that they are in such a hurry they appear to be reusing old forms and not clearing out old names and companies before submitting.
Creating a lot of negative PR or at least the appearance of such.
Some here apparently want their share holdings wiped out asap.
Or maybe they just want OUR share holdings wiped out asap.
No comment on what a replacement would do to put window dressing on a company that has an effective treatment already ? Just want a replacement because ?
Every individuals investment decisions are that individuals responsibility, not the CEO or CTO or CFO or CMO.
In my opinion any replacement that comes in and doesn't already have skin in the game is going to have priorities that don't necessarily include the current shareholders.
That replacement will want to "whitewash" the company to make it look more palatable for future investors. First step would be to reduce the share count.
A 1 for 20 reverse split at the very least would be step 1.
A 100 million dollar raise would be next, diluting RS crippled shareholders further.
A partnership with a BP would make the most sense as a next step and probably dilute the company another 50%.
From that point we would still be a year or more out for any approval.
So, you can see why some would rather bet the next 4 months on NP getting an EUA and some revenue on the table to avoid the above.
While I agree that NPs penchant for being vague is very annoying and his lack of following up after making claims is also a detriment to this stock, his and the rest of the company efforts should not be minimized.
If leronlimab does get an EUA, the crew at Cytodyn get the brunt of the credit, while many shareholders have tried some activism with the FDA and also pushed some political buttons, I applaud them for their efforts.
However.
If not for the Cytodyn team, there would be nothing to push, no proof of concept, no product to evaluate.
No product to evaluate.
The most basic part of this whole stock drama.
No one can take the credit away from NP about that at all.
LH is Phase II, it has to be completed. Then Phase 3 designed and protocols submitted, this will have to be a large trial, which should still be able to be enrolled quickly. However we are talking end of 2021 at the earliest. Maybe Q1 2022.
As I said EUA and CD16 do not mix. its one or the other. I prefer EUA. Because other countries will follow.
I suspect NP using "Conditional EUA" as a placeholder until he gets CD16 underway, which in my opinion they should already be at. However, if he states they filed a "Conditional EUA" it buys a few more weeks. Then we will never hear of it again and they will announce CD16 a couple of weeks away from first patient.
Cytodyn's best bet is to sell to a Country that has a need for a solution right now. This would be a Country that does not follow the US FDAs lead. That is where he should have started concentrating efforts two weeks ago.
He also said that they didn't have any data on the OLE patients.
Like I said, I hate NP word games.
The only problem I see with that, is that CD12 showed which population gets the most benefit.
Under 65 critically ill is the best condition for proving Leronlimab works.
If a conditional EUA was granted this would be where the FDA would grant it.
That is also the patient population that CD16 is going after.
An EUA would get in the way of enrolling enough patients for CD16.
I read that yesterday, and while NP had in the past stated that the UK would be involved in CD12 it was never confirmed, and no UK hospitals were listed in the CD12 18 hospital list.
I really dislike the NP wordgames.
There is a lot of fodder for Nader in the subject of the UK and what may or may not have been filed there. Many questions that can be asked about this subject.
I really hope that he has something concrete for Monday, if it is another kick the can down the road episode, the price will break down below $2.
It's been two weeks since the last call , I would hope they had accomplished something.
US - Conditional, the condition is probably completing the 140 patient CD16. Oh yeah, they didn't say anything about the FDA accepting the trial protocol and allowing them to start.
Canada - Hopefully, but it will probably follow the US FDA
UK - Rolling Review. Did they file anything there ? Rolling Review would mean the UK wants more info and they are going to feed them more. Where are they going to get more ? Only place Is CD16. So basically saying they did not file anything and need new trial results
Brazil and the Philippines appear to be a nothing burger. They really should have concentrated on Brazil, all other governments will follow US FDA.
It's possible, they claimed to start trial enrollment in Uk I think last summer, yet none of the listed Hospitals for CD12 were in the UK.
Maybe they did not get set up in time, but are ready for CD16. We can only hope.