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I see the moderate and critical trials.
Wasn't there supposed to be a severe Trial ? Or did that get waved off in favor of moderate ?
He is not mistaken, that is the treatment protocol for the 594 patient moderate trial.
Yup, they are doing a phase 3 that follows the patient population that benefitted most in CD10.
NP covering all bases.
Lot of potential here.
Stock price down.
FDA hit piece.
Resounding short action.
This is the best opportunity before some possibly positive catalysts hit.
Lots of members of this same group sued Cytodyn and the board for self enrichment at a time when CYDY HIV BLA looking possible but the co was vulnerable. Bad timing if your for the company yet good timing if against.
Yet Pestell owns the most shares in Cytodyn, as you say in return for what ? Who has really enriched themselves here ?
Jmo
A few of those key players are not new to Cytodyn and did not accomplish squat.
Matter of fact Pestell was C-suite during much of the touted HIV shenanigans.
I think much of his baggage attributed to NP.
Jmo
Both groups have always been here.
One wanting Cytodyn to fail outright.
One wanting Cytodyn to fail enough to be wounded and easier to take over.
Both, maybe working towards the goal of 1 or more bigger entities.
Jmo
Yup and Tony C has ties to Gilead.
Not good for Cydy in the long run, IMO.
In my opinion this is the first step. Get a seat on the board.
They will then start pressuring Cytodyn to purchase InCellDx.
It is not because they need IncellDX for anything it is because it will take lots of shares to buy it. Up to 30% I have read.
The group then goes from 5% to 35%.
I would bet that other small investment groups tied to this effort already exist and are hovering under 5%.
I now see the reason why some "SUPPOSED LONGS" have posted constantly against NP and Cytodyn actually despite this company being far beyond where it was when some of these former Cytodyn players had influence.
They did figure out that Pestell is the largest shareholder by convincing the company to buy his. What was gained by that ? Just lots of shares by Pestell,
If they can do this again, they may just be able to get a majority voting bloc together.
We will know more where Cytodyn stands in COVID19 and LH by then.
jmo
Good find Rosco,
I was wondering why Sidlo had updated one of his videos on Vimeo a few months back. Usually see activity on the videos when they are courting an investor.
We will see if anything comes to fruition on this, I agree that its just a twich.
I don't see any heavy activity being possible in India with the Covid19 situation there.
I was looking on LinkdIn last week and there was a heavy Indian presence in the employee list, so it seems most activity is there, if any. They are pushing the High Temp batteries. This is most likely because they did not make headway with the Lithium Metal batteries after parting ways with the inventor.
With control of 30 million shares out of over 600 million, that would be like the flea on the tail, wagging the dog.
To me it looks more like somebody wants to take control of the ball right before the touchdown play.
Depending on when the shareholder meeting happens vs the Brazil Critical Trial interim readout , this this could be interesting.
Getting a board seat and a complete hostile takeover are very different things .
The LH Phase 2 trial results and Brazil Critical Trial progress will have profound effects on any vote that is put forward.
Jmo
Great post.
They harpoon CYDY Trials, then shrug, "But it didn't meet the endpoints."
I will give Nader up until the trials are completed in Brazil and if a trial is asked for and completed in India.
Sorry, but now is not the time for disruption.
Yeah, this isn't about a personal grudge with Nader. It does not matter who heads Cytodyn as long as it controls Leronlimab.
Cytodyn will be choked till it sells out to BP for pennies on the dollar. It is the financial threat to BP that is the cause of the Animus. Initially this was about HIV and threat to Gilead, now it includes Covid-19 and soon LH.
That is why LL must be proven with Trials in Brazil and begin to sell internationally from Covid with revenue bridged to LH and finally to other indications.
Actually,
Headquartered in the USA, made in Korea by Samsung Biologics and sold worldwide except the United States. And I'm OK with that Also.
3. Everything in CytoDyn’s development of the HIV indication was “ass-backwards”
4. CytoDyn has stumbled along for years, enrolled hundreds of patients, and spent untold millions of dollars
The most ironic thing in all of this is that the FDA rebuke can be laid at the hands of shareholders, the doctors and others who sought to pressure the FDA to take the existing data and act on it.
NP has cautioned at the investor CCs more than once not to harass the FDA, but too many who are focused on share price now, sales now even saving lives now. Pushed the envelope failed , and now NP is the villain.
Yes he does have some responsibility in all this. But hey, if he could tell the future he wouldn't be working at Cytodyn.
The change in NPs language about LL is not because his opinion changed, its because he is under the impression that he and his positive wording about LL caused the Pushing on the FDA. So he is trying to defuse the bomb so to speak.
My opinion is that too many shareholders think they are smarter, can do better and we're trying to do Cytodyns job for them. Well take a bow, Cytodyn being in the cross hairs is thanks to you all.
Jmo
Simple, he needs them for future Approvals. Only an idiot would publicly malign the FDA if they hope to be able to do business selling therapeutics in the USA.
All the advertising on 60 minutes is nothing but Drug commercials.
60 minutes makes massive advertising revenue from BP.
Thanks,
Its not a coincidence the FDA release, and a flood of anti-management postings coordinated at a crucial time for Cytodyn.
Almost like magic, but not.
Neither do you , just the ability to make a statement.
That will be remedied soon, and show it works better that anything else on the planet .
Get it ? On the Planet.
Pretty sure he didn't say that on a Proactive video.
It was in the Q and A on a CC.
Nice try.
Once the trial has started there is no choice to be made.
In March 2020 not very much was know about Covid.
It's easy to be a Monday morning quarterback.
Anyway, these issues will be handled in the next 2 Trials. In a place where the FDA does not call the shots and cannot affect the trial.
Jmo
No they don't write protocols but they decide which protocols to accept and which ones to deny.
Blaming Amarex and Cytodyn for the 65 and older enrollment numbers ?
Double Blind Randomized , some obviously don't understand what that means or how trials are conducted .
Data at the halfway point and data at the end can be very different.
It does not matter any way, the FDA statement is a CYA for them. They know a severe Trial and a Critical Trial will begin soon , they also know how well Leronlimab will work with proper dosing that they did not allow.
With the EINDs, OLE, Philippine results and finally 2 trials that will show the true efficacy of Leronlimab, they have to have something to point to, as why so many Americans were allowed to die.
Unfortunately, their CYA has some untruths and when people start asking questions in the fall, it will actually make them look worse, especially when they are involved in stock manipulation on top of everything else.
Jmo
Covid is not dead. Even here in the USA.
Half the population is vaccinated.
The CDC, wants or thinks it is putting pressure on the rest of the population by doing away with mask mandates for the vaccinated then insists people be honest and wear a mask if not vaccinated.
It's an honor system.
Human nature will easily overide that and we will be open and maskless with 50% of the population vulnerable.
It's sad to say , but we will most likely have another wave . Mostly because we were failed by our nations leaders and our Health Agencies
Do you really believe long shareholders sold in response to a statement about results that are already known ?
The big sell down would be shorts.
They weren't covering, they were selling, this may have been a response to inquiries by the Indian FDA in their due diligence for an EUA in India and the FDA put the kaibosh on it.
They need to ramp up CD16 and CD17 asap.
New Trials with P value will be the only way to counter the FDA.
Calstang66 am I remembering correctly that this week Recknor was supposed to be getting interviewed by same network that interviewed NP last week ?
No, not short , I'm long. Bought a thousand shares when it dipped right after the Merger. I also bought 3 thousand warrants which I converted to stock.
I'm in at an average of $6.89 , I don't think it will ever get that low and if it does I will buy more.
I will hold this a minimum of five years.
His Battery Vendor A123 Systems had battery failures right out of the gate and went bankrupt.
The Fisker Karma production was suspended and then Fisker Motors went down the drain and was bought by a Chinese co.
The car was still being built and very sleek .
You would hope and so would I.
The Pro-Active video has Nader stating the situation as it happened with a different drug. The Regulatory Body wanted a small study they did 30 then wanted an 800 patient study.
This is most likely what they will want from Cytodyn.
Yet NP keeps pushing the Fantasy situation of an EUA while they run a trial. Its a scenario that is unlikley to be approved by the CDSCO.
They are smiling pretty big and Dr. Kelly is usually very stoic, maybe they got a shot at EUA or a Fast trial or this is tweaking their prospective BP talks.
Still need something more solid, that actually positively affects fundamentals and doesn't just up the potential.
Sure it was.
You have bagholder and investor all mixed up.
LH trial , apparently they didn't learn enough cause Recknor wants to do a 2B Trial that will add 6 months to the LH effort . Let's say Phase 3 finishing 1 year from now. No revenues on that front.
HIV maybe BLA complete by the end of the year. Add 8 months to PDUFA time Nd get august 2022 so maybe first revs 3 months later
Cancer Basket , NASH , other indications need Phase 3 trials so you are looking at 2022/2023 completions then BLAs so 2023 maybe for revenues from that .
The only chance is Covid-19. No regulatory approvals, no EUAs. No revenue yet.
NP didn't fail to go to charm school, he missed Business School.
The only thing that consistently goes up here is the Outstanding shares
Right, trading on emotion means you are a true shareholder.
Yes, PUMP
What are you going to call the stock price increases in 2020 that could not be held because there were no fundamentals to support the price ?
I haven't sold any share of the over 75,000 that I own. However on the next pump I will divest a good portion.
NOPE.
I'm waiting for some real hype from NP, he will get the price jacked up so that Mulholland's wife can sell, that is when I will jump out.
I am just no longer supporting the Myth.
That's a very active imagination.
Imagine that this turns to crapolla like everything else NP touches.
Now lets lay down odds on which will happen.
Nope, just the example of past Failures of NP and Cytodyn.
They never announce failure or announce when they quit pursuing a market.
Its always next week, until it becomes nothing. Then a different carrot will be mounted on the 10 ft pole.
I have seen one year of delays, fill in fluff, followed by a distraction, followed by silence of a failure, followed by excuses, followed by a shiny new thing, followed by bull slinging.
The only things that are a constant..
No SALES
No Revenue
No Approval
Of course how can you ever get an approval if you never complete an application.
I have a new name suggestion for Cytodyn. " NOTHINGBURGER PHARMA "
It will have lots of potential, lots of stock sales and no revenue.
I feel like I bought shares of Farrow Tech in the movie boiler room.
jmo
I'm not short, I'm disgusted with this company that can't actually close a deal for sales, not even to stockpile for if it gets regulatory.
So much potential.
ZERO SALES.
Yup, just like the Philipines.
No revenue in the Philippines, just a few announced CSPs and nothing about actual numbers, actual revenue ( if any ), since he has not announced most likely no revenue in the Philippines.
NP likes BUZZWORDS and Powerphrases and catchy commentary.
Last year..." I have 1,200,000 vials. " This year " i have 1,200,000 vials"
" I have reserved 100,000 doses" then " I have reserved 200,000 doses" A lot of meaningless drivel coming from NP. Because its never " I sold XXX,000 doses "
" I have a distributor "
" Compassionate use "
The best one I heard on a CC very recently.
" I'm gonna ask the FDA to let me charge HIV patients for an unapproved drug in the USA "
That told me how much of a bull slinger he is. And he expects shareholders to eat this up. And some do. I heard that and I stopped believing in the Myth.
Sorry, if it walks like a duck and talks like a duck its a duck.
jmo