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No, Jay is saying that what Nader and Kelly were saying is true and he stands by those same claims .
Hence, if that was why they were or are investigating then it should be a Non-issue , as claims about LL effectiveness are true.
I guess in the end all that needs to happen to get the DOJ and others off of Cytodyn's back is to verify trial results.
Jmo
This is where it gets tricky for NP.
Can he leave well enough alone and let the 700mg Nash be analyzed properly and also let the Brazil trials enroll normally ?
Or is he hammering on Recknor relentlessly causing bad blood with his best employee ?
He needs to let positives be that even if we have to wait. Releasing vague results and messing with the Brazil Trials will have direct permanent consequences
Jmo
Looks like Nader zigged when he should have zagged.
It doesn't mean LL did not meet standards, means the FDA changed the standard.
Where Nader fails, he should have had the brain Metastases BTD ready to go and submit. What excuse can the FDA give ? What's the SOC there ?
Then while waiting on Brain Mets , prepare MTNBC and resubmit again. Bombard the FDA with results while keeping Brazil trials alive and progressing. The Brazil trials are set up and enrolling very slow and Brazil cases will rise and enrollment will pick up.
This is extremely important, Nader needs to let the Brazil trials fully enroll and not monkey with additional numbers because he can get the enrollment numbers needed in a surge without poisoning the trial data with non trial data.
In my opinion the FDA is allowing non trial data so that when Cytodyn does submit they can be picky and disallow data...that eats up time and gives the FDA plausible deniability.
Nader and his impatience and love of the shortcut will fall into this trap over and over.
The time eating process of setting up the trials , CRO , et all, are done in Brazil, cases are rising and will continue. He needs to not interfere in the process.
He needs to establish foreign markets and enough countries will follow ANVISA that will allow Cytodyn to survive, thrive prove it's power, then he can deal with the FDA from a position of strength with irrefutable data
Jmo
Per Nader's proactive today.
Did NP just suggest enthusiastically that they would request the ability from ANVISA to combine the data from CD12 with CD18 ?
Combine a statistically failed trail with a hopefully successful trial ?
I am sure if they allow it, they would not just let him add cherry picked data from the successfully treated patients he would basically be watering down the results of the Brazil Trial.
I mean seriously, how do you combine results from different treatment protocols and call it science ? This is the PLacebo arm, this is the control arm and this is the outta control arm ?
Like I said, Nader loves a shortcut, he will shortcut this company to death before he is done.
Nader did not show much enthusiasm about the possible US critical trial, seems like he will be using it as straw man to distract from the other things he is not doing. I do not believe we will ever see a US Critical Covid Trial. I do not believe LL will be used to treat Critical Covid in the US EVER.
I believe Nader will stall any mTNBC BTD application for 2 to 3 months and we will be shooting for July 2022 if at all.
Longhauler ? was not even mentioned.
Brain Metastases ? was not even mentioned.
This stock may reach .30 again.
jmo
" Who needs Covid ? "
A company with no revenue on the horizon for the next two years could probably use a pathway to make revenue and a pathway to use up expiring Leronlimab product.
LH is a phase 2, not even looking at starting much less completing a phase 3 till 2023, completion and BLA 2024 ?
Nash - Phase 3 maybe in 2022 completing in 2023. BLA ? 2023 or 2024 ?
HIV ? Let's see if they can submit a complete BLA at all, then see if it is accepted by the FDA then at end of 2022 maybe I'd lucky approved. That's combo therapy, not even mono therapy so mono therapy in 2024 ?
Covid was the only chance of saving this company from bankruptcy by cash injection and using up existing Leronlimab before it's worthless.
Jmo
In December Nader most likely dismayed at the poor stock performance after his PRs about the "Open Label" 350mg Nash results , scheduled a CC. This was pushed by pumpers as a huge event ushering a major announcement.
Nope, it turned out to be the " don't short your brain" CC . I guess it was intended to calm shareholders and clarify that 350 Nash results were positive. Okay.
In that CC Nader claimed they would have the NASH 700mg results from the Blinded trial before Christmas.
Christmas came and went, new Years came and went and finally yesterday they basically rehashed the 350 mg open label results again, but made it seem like this was the data we were all waiting for
No
This was just more of the same info that did not move the stock price a month ago.
Where is the 700 mg data that was promised ? Is it waiting on BTD to soften the blow ? Or is the 700 mg data being held to soften the BTD rejection blow?
The world is exploding with Covid yet not a peep from NP in any way,shape or form on Covid. When this surge is done , I am pretty sure he will be yelling Covid from the rooftops.
Then he will be dumbfounded that nobody cares.
Jmo
He once offered to by back my shares at the same price that they paid out the fractional holders. Dummy me, I should have sold them all back.
As always with Cytodyn.
They hype it like crazy before they attempt to "penetrate" a market, with half baked methodologies or sometimes even with proper trials.
After the pre-hype, they never talk about them in a significant way, especially to update on results.
Nader loves a shortcut, he will spend ten times more money and resources on shortcuts then a proper path to anything. When those shortcuts work against him, he conveniently doesn't mention them again.
Triple digits, quadruple digits, quintuple digits, seems like all we get are digits on the wrong side of the decimal point.
jmo
Who writes these garbage PRs ?
The title:
Leronlimab 14-Week, NASH Clinical Trial Met Primary Endpoint (PDFF) and Secondary Endpoint (cT1) for Per Protocol Population in 350 mg Weekly Dose
The Body of the article contradicting the title.
Except for the fact that in this PR they claimed that they used the data from the Placebo arm.
This means they have the data for the study.
I agree with you on that.
However , they claim that they are using the placebo data from the controlled arm. That would indicate that they have access to the data. Yet no topline ?
I'm sure that later Nader will nonchalantly mention it was from other companies trials.
What I am railing against is Nader's continual " place holding" with timelines that are never met. He seems to be attempting to support the share price with nothing but vapor while he waits for a result in another indication to provide actual price support
The problem is that those other things never happen.
Jmo
It's too bad that Nader couldn't be patient and present what was promised before Christmas which is the " placebo controlled" 700 mg results.
Instead they played the old switcheroo and made up trial results with other people's placebo results to pretend that they did not just re-gurgitate the open label data again.
This unfortunately is the kind of PR behavior that gives this company a bad name and why these PRs will no longer move the needle in share price.
Meanwhile.
No Longhaulers trial yet.
No US Covid Critical Trial yet
No update on Brazil Trials yet
No movement in the Philippines.
Jmo
It seems more likely that the 13D in their arrogance and stupidity complained to the SEC. The SEC took the complaint at face level and responded to Cytodyn.
The Sidley response and subsequent court results should result in the SEC taking a deeper look at the " Shenanigans ".
In My Opinion, Bruce Patterson was stupid in the path he took to force a takeover of Cytodyn. The actions are in plain sight now, the motivations may take more investigation.
The fact that Superchet was outed should provide a bread crumb trail that can be followed to some serious stock manipulation tactics.
Other IncellDx shareholders/investors and their activities on other stock boards is a slam dunk in showing a broader attempt at stock manipulation. While the messages show one thing, trading patters and 13D PR timings will show some serious coordinated efforts imo continuing to this day.
jmo
I have many relatives that live in New Mexico, have tried to speak to one of them who works in a NM Hospital about Leronlimab and shut down very quickly. Stopped even trying about 6 months ago.
I am not surprised about that reaction.
Sorry to hear that the arrogance and closeminded attitudes are alive and well in NM.
jmo
Seriously ? Topline Phase 3 in Nash might happen in 2023 or 2024 but never in 2022.
Cytodyn has opportunity in 2022 for topline in LH, if their protocol is accepted soon.
They take about 6 months to do prep for a trial with designing and submitting the protocols and then waiting for authorization. To begin from the FDA.
Getting hospitals setup takes more time. Then finally they begin moving forward.
Of course enrollment is the other chasm that must be navigated.
If this meeting is just updates, the shorts will likely be successful in driving this below a dollar.
Cytodyn better have something of relevance to announce that moves the needle.
Jmo
As long as they get this approved for the trial to start quickly.
Otherwise it is just going to be another Brazil.
Brazil will have another surge, most likely after Christmas and New Years celebrations. That surge will be capped off by Carnival, after which it will peak.
Let's see what Cytodyn and the FDA can put together and how quick it can happen.
Jmo
I think the Fat Lady is in a Covid Coma , she ain't gonna sing.
They signed up 4 by Annual meeting.
At that rate it will be 50 by June.
I'm confident that this trial will never finish. What we saw today is Nader setting up the disappointment so when he ignores this in Jan and Feb there isn't blowback.
By March he will sing the praises of Anvisa who stopped Covid in Brazil.
Much like he claimed the US FDA was doing such a great job in the US , so he was taking the trials to Brazil. Talk about avoiding the mother of all surges.
Well I guess we know now that he zigged when he should have zagged.
I mean. Really....who chases a worldwide pandemic for two years in 4 trials and can't enroll them.
Jmo
I think that Canada, the UK, India, the Philippines and now Brazil have been someone trying to get a "message" to Cytodyn that they will be blocked at every avenue.
This has happened way too many times to be coincidence, Nader needs to get the hint.
At this point, I feel that if Cytodyn has to join the "FRAT" and give something up to do it, they should.
Jmo
Seems to me that Lalezeri has interpreted the Brazil trials as an intentional slow roll as I have.
Without making accusations he appears to be requesting that the US govt get off of Cytodyn's throat and let the Brazil trials move forward.
This would most likely be through a partnership with a golden chosen big pharma to be allowed to benefit from the Covid or a tradeoff to Longhauler.
NIH = Fauci. Fauci = Gilead.
Gilead would most likely be the recipient of a Soprano's style " union no show " job.
Jmo
Nope. Just been watching what actually gets accomplished and followed up on by management.
What are you gonna say when the BTD gets shot down by the FDA because they want more information ?
I would say we are at 50/50 that this will happen.
Cancer is years out, NASH is years out. Even LH , this is a phase 2. A second phase 2. After this would be a phase 3 , or as Nader says, he can turn it into a phase 3. I guess magically ?
Covid during the pandemic was Cytodyn's only chance of near term financial success and Nader just poo pood away that opportunity in the annual meeting. He is very confident of BTD but I'm not so sure he should be.
Jmo
Crying ? seriously ?
Face facts. Brazil not moving at all . Over 1,000 dead per week. Leronlimab Trial over a month time frame ? 4. I guess all those Hospitals are empty. This must be why 4000 died and 2 received Leronlimab. At this rate, we will hit the low interim in 1 year. ( Low is 50, not the 140 ).
LH, not allowed to start by FDA , does not matter how much money.
Philippines ? Don't have to say anything about this at all.
.
Jmo
Thats right !
And...where are our Covid Trials in Brazil ? 4 for Critical and 20 something for severe. Can you say SLOW ROLLED ?
Critical Trial in the US that NP was hawking over a month ago ? Nowhere.
Can You say SLOW ROLLED ?
LH in the US which is ready to enroll its 250 asap. This is a Phase 2, not even a Phase 3, yet waiting on the FDA to accept protocols or evaluate endpoints or whatever. Can You Say SLOW ROLLED ?
The Philippines, some good doctors interested in saving lives have embraced Leronlimab. The other 99% willfully keep their heads in the sand. RESULTS ? we don wan no stinking results. What happened with the supposed infusion center ? Is it like Brazil and infusing 4 per month ? It seems ignorance or indoctrination ( take your pick ) rules in the Philippines.
jmo
Yeah, it does that every week, as reported cases from weekends are low.
Same story as always. Leronlimab saves lives !
Not until its given to a patient it doesn't.
If it takes 100,000 cases a day to fill a lousy 350 patient trial in 3 months, something might be wrong.
Jmo
Supposedly 20 hospitals in Brazil set up already or more for Critical.
It seems like Cytodyn stops Covid19 nationwide by attempting to do drug trials in a Country.
They started talking to India and boom, pandemic slowed to a crawl.
Talked with Brazil and no change, however started trials and boom like hitting the brakes.
The Philippines bought a small stash of Leronlimab and Boom! Pandemic is over.
If the US is smart they will start a trial with Cytodyn and before enrollment begins, the Pandemic will be over.
I never thought I would own stock in " The Charlie Brown Company " Yet here I am, got a rock at Halloween, will probably get Coal for Christmas and forget Valentines day.
jmo
He was the man in charge, but do you really think that as a "real estate" guy he was the one who found , researched and made the decision to buy the compound we know as pro-140 ? Didn't he leave the company right after that ? Is that commitment or what ?
Cytodyn had another drug that was not "humanized" that they began with, the process to get it humanized would have cost the company a lot of capital. They needed a ready made compound and that they could afford.
There appears to be a belief that every piece of paper signed by a leader in a company is personally vetted by that person to the Nth degree. That is not so, that is why the other employees are hired, to do the work that the CEO or Executive Chairman do not have the time for.
Most times that includes research and due diligence on products, equipment, suppliers, pretty much everything under the sun.
Jmo
This is why I posted in the past that Cytodyn should have reset the date of record for stock ownership when they rescheduled the meeting.
I currently own more than 30,000 shares that I cannot vote due to the fact that I bought them on dips after the Sep 1 date.
I can pretty much assume that the someone who sold that stock is not voting with the company. Its possible they may not be voting at all, since they sold and are no longer intereseted.
Even though the BTD application is very good news regarding the potential of the company, it is not guaranteed.
I will not buy any stock in this company till after the 200 Million authorization vote is settled. If the 200 million is not authorized it will not bring about the bankruptcy of the company. What it will cause is a different strategy for freeing up existing shares.
That strategy is called a Reverse Split and depending on the ratio can free up 400 million to 600 million shares.
You dont have to be a math genius to know that Dilution after a Reverse Split is compounded dilution which is very much worse than adding 200 million to the authorized, It immediately affects shareholders, whereas authorizing the additional 200 million means they might take a good long while to use them up.
The 13D thinks they can force Cytodyn to work with them on a financially crippling deal for money. They are wrong, there is that other more drastic approach that Cytodyn can take that will decrease the 13D Groups owwnership and get them additional money.
jmo
I think this is a funny play on words.
Yes , unfortunately I have long holders.
This might have also kicked up my IBS , which is strange because I have never had it before Cytodyn and LL.
No tears yet , but I do use Johnson and Johnson shampoo. They promised no more tears. I also listen to Ozzy, his song " No more Tears " is very soothing.
Jmo
A normal shareholder of record can request their control # and just go to www.proxyvote.com and enter that control #. It will take you right to the voting page and give you links to the proxy and 10K that you can reference.
Right so he has a Rolling BLA.
But you say he tells Amarex to submit the whole thing in one fell swoop ?
That is where context is needed.
Submit a module , even though the BLA is missing parts. Meaning without saying " hey Amarex ! Let's show some,progress".
The context we do not have in this case is whether he was told and believed some module was complete and that is what was being referenced .
Why have a rolling BLA if you want to submit it in one package.
What I do know from the RTF letter is that Amarex cannot be trusted at all. So I am going to trust them that this one email encompasses all communication between Amarex and Cytodyn about the BLA ?
I think this is called " cherry picking" or " data mining " so some are doing exactly what they accuse Cytodyn of doing .
If you aren't 13D they should induct you as an honorary member.
Jmo
I'm not talking about any of that. Solely, what does Cytodyn say that they are going to do
What does Cytodyn get done ?
If it relates to any kind of filing , it seems like nothing and never .
Jmo...in this case is not my opinion it's just my observation.
When NP says it's taking longer because of finding new exciting info, usually means they hit a roadblock and will stop talking about it.
Jmo
I also voted for the 200 million especially as the extra time will be needed.
That being said, I will also say that I am pretty much sick and tired of Cytodyn's inability to ever file anything that they say they will file " In A Week "
When Nader makes these claims it's never late by a week, or two. There is never any follow up. Everything just goes quiet and the next time he has a bullcraph CC it's on to a different flavor with no mention of the last thing they didn't file with the FDA or the MHRA or the Canadian FDA.
It's a pattern and is also the reason why supposedly great sounding results Garner zero stock price support .
I'm no longer buying CYDY stock no matter what the price I have put my own timeline requirement on Cytodyn and if I don't see anything filed with the FDA or any promised update ( that were never given) on Brazil I will start unloading and walk away from this failed gamble.
Jmo
The shredding of Cytodyn's case was more of a simple contract dispute in which Tony C made the contract with Pestell as ironclad as possible and completely favored Pestell with nothing to protect the company.
That's right, nothing to protect Cytodyn in the event of stalling or non-performance.
So, once again. Blame the 13D.
Amarex ? Blame the 13D.
The Advancing Leronlimab group appears to be exhibiting the same symptoms seen in many dysfunctional relationships , which is the problem of " projecting ".
Jmo
It's laughable that 13Ders keep shouting "independent board "
Yet
Their board nominees were interwoven with each other and through InCelDx like a macrame.
The new CEO in their world would be beholden to the Board Of Directors who would be tied to the 13D shareholder group.
Yeah , thats really independent .
I guess from Nader and all management with knowledge of all the trials that CYDY ran because they would all be gone in a 13D win.
Jmo
Sometimes the 13D buries their agents deep for a later Pied Piper attempt. I noticed the shift sometime last week.
I also noticed tried and true longs " supposedly tried and true " have all of a sudden disappeared .
It doesn't really matter, people will do what they do and say what they say. The thing to pay attention to, is the sudden sentiment shift and go back and look at all the others in that ring of people and see how they are posting ...or not.
Jmo
One thing seems apparent
13D going after NP, because he has blocked them time and time again.
Shorts pile on to benefit and also go after NP.
Now Amarex targeting NP, but much like the 13D they are either too ignorant, too arrogant or just like a deer in the headlights in the methods they choose to employ.
Everybody who wants Cytodyn down, is after NP. They want him gone because they appear to think it will get them what they want if he is gone. I guess that means Pro Cytodyn shareholders should fight to keep him.
Jmo
Uhhm no.
When BLAs were delivered in Paper form they were delivered on pallets
At least that's what I have read.
Jmo
It's not a mystery what they would want to trade for that 100 million.
Pretty much the same thing they have always been after. They want a billion dollar company with 100 billion dollars of possible future markets.
And the best thing is that they get to keep the 100 million in the end, after they take over the company.
Win, win for the 13D and InCellDx and it's shareholders. Oh Wait ! Did someone say those are the same people ?
I guess we would have to say Win, Win ,Win.
The 13D needs to be held accountable for the damage that they are doing nonstop.
Jmo
Since it was a "Rolling BLA" I read that and it looks like he was requesting some movement. In other words he wanted modules submitted which would show progress.
Even now they are hurrying in my opinion.
The CMC portion which they have " chosen Samsung " does not make sense to me. They might be screwing up right there. You don't just choose who will be manufacturing your drug and submit their data
They have to show that the drug used in the trials and the drug they are able to manufacture are identical. This means the original plant gets inspected by the FDA and all that manufacturers data gets included in the CMC.
I was in another stock that spent a year on the CMC portion concentrating on 2 manufacturers who would be making the drug commercially after approval, drug batches were produced and tested for accuracy in manufacturing all was supposedly done. Rolling BLA and multiple meetings. At PDUFA time they received a CRL because the original factory in Canada failed inspection.
We will see what happens.
Jmo
You cannot deny someone or a lot of someone's have sold their CYDY stock since sep 1.
Maybe some or a lot of 13D but probably also other holders who got tired of waiting. Maybe tax loss folks who want to jump back in , after 30 days and before catalysts.
Either way, once they sell they aren't interested in voting, I have done that even though I was a shareholder at date of record
There was a very late fumble bumble with this due to them waiting on the Chancery Court.
It's very easy to review and vote, everyone makes it too difficult waiting on email, or worse snail mail USPS when all that actually had to be done is get your control # from your broker and then go to www.proxyvote.com enter the control # and you are there.
Jmo
The real question is, where were NP and Kelly that they were in Hotel Rooms, two days before the Annual Shareholder meeting ?
As for the votes, something smells.
I will repeat that I voted all my shares, thru the Proxy Vote links at each Brokerage logged out, logged back in and checked and all stated "You Voted" 2 days ago didn't answer a call my phone showed as "spam". They left a voice mail I halfway listened to with voting instructions.
Today, got a call from the same number and they left another voice mail. So, someone thinks I did not vote. But I did, online through proxy vote as I have always as done.
Something isn't right.
Jmo