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I think the existing bad news is what was in the updated shareholder presentation.
Kind of a "look under the hood" for a prospective buyer of a portion or all of the company.
At this point I would take anything above $30/ share and be happy about it.
jmo
The good or bad is always subjective.
However, since they are updating various aspects of the company business it could be they are selling the company, or selling or licensing an indication or indications.
They have repeatedly made mention of the fact that they expect Cytodyn to become an Oncology company and so that is where they see the greatest promise for Cytodyn.
In order to survive and to achieve that goal, they may be selling other indications in order to pay off debt and fund their future. It may be something that shareholders have to vote on or it may be something that just requires full company disclosure in order to cross the T's and dot the I's.
I would say its a selling off of some parts and good for the bottom line and survivability of the company.
There is also the possibility that this was updated and will be presented to potential buyers and was posted to the investor relations portion of the website as a requirement of all shareholders to be given relevant company information.
So, I am not saying its a done deal but rather preparation or part of the process for attempting a deal.
JMHO
Rahman let it expire and maybe it was why he was let go, but it does not make any difference.
Rolling Review allows a company to submit their BLA in modules but the FDA does not look at each module and give it a thumbs up or down. They don't look at the BLA until it is fully submitted.
So it expires, they resubmit the whole thing when they have all the requisite data.
Until 100% of the BLA is submitted, then it's the same as nothing submitted.
Armchair quarterbacks are up in arms because of a nothing burger.
If you look at the presentation there is information there that is not palatable, in my opinion it was put out to inform shareholders as a requirement for something. This is serving as a kind of a CYA for the company so that a coming event or development is not invalidated by a technicality that shareholders were not fully informed.
Jmho
So Scott Kelly shared an email with you ?
I find it hard to believe that this is legitimate. Especially with the wording of the supposed email.
Trials appear to be in the works for Brazil and of course our new trials in the US.
I do not think even the Philippines will give an EUA without a trial that shows P value and an acceptance from our FDA. We have all read how the FDA insists it is just still just an investigational, the only thing that will budge this in their minds is an approval, even an EUA but nothing less from another FDA.
April 19, 2021 6:05am EDT
Clinical trial in U.S. for critically ill COVID-19 patients expected to initiate soon
CytoDyn in discussions with Brazil to initiate two COVID-19 trials, one for severe and one for critically ill patients
So you are admitting that the people in "the trenches are requesting Leronlimab "
And the Philippines FDA just told them how to get it.
CSP
It's available.
NP stated that the mortality on the OLE patients was 17%, which was better than the results of the CD12 trial. That was counting 55 OLE patients at 28 days.
Because those 55 were at 28 days and were not the total number of OLE patients, the number will keep increasing of patients treated. This will continue until CD16 and CD17 begin, if that ever happens.
I think at tis time we have approx 90 EINDs, 390 from CD12, 55 PLus on the OLE, 29 Philippine CSP so over 563 patients treated with LL for Covid19.
With the CSPs cranking up in the Philippines this number will grow quickly.
I think the "Manila 28" were treated under 1 CSP for the Hospital, this can be used more effectively than the EINDs at US Hospitals that require lots of paperwork per patient and are individual EINDs.
Because if a trial is ongoing all OLE and EINDs would be shut down.
There would be no pathway for you to get Leronlimab any other way, other than flying to another country. And Medical flight out of the country would be prohibitively expensive.
So everybody in 18 US hospitals in the ICU is gonna choose to fly to the Philippines instead of joining a trial ?
Right, so I'm in the hospital with Critical Covid and I'm flying to the Philippines.
Let's make this specifically about LL
In this scenario LL is saving lives in the Philippines so it is proven to work spectacularly.
But it is not approved in the US and Cytodyn is running a trial .
I get given the choice to participate . Heck yes, because I have a 50/50 chance of getting Leronlimab.
If I don't participate, I get SOC. Which is the same as the Placebo arm
Why would I choose not to participate ?
The facts are the facts unfortunately.
I wish the FDA would take a second look at LL and say EUA approved.
However , I do not expect it to happen.
They will hold Leronlimab back because they can, while claiming to follow the rules. It will be this way until a Trial with a passing P-Value is completed.
CD16 and CD17 being required by the FDA for an EUA in the US are not affected by the drug being sold or given an EUA in another Country
If the FDA will not give EUA without a Trial passed without a requisite p-value then that is what the company needs to do
A phase 4 confirmatory trial is usually required by the FDA when a drug is given accelerated approval but has followed all processes including Phase 1, 2 and 3 and submitted a BLA The fact that some factors may not have been measured or tested more thoroughly is what causes that to be required.
The drug gets approved and goes commercial but trends are monitored and the approval can get recinded.
The drug being purchased by another Country or multiple Countries has no bearing on an FDA EUA.
All that will happen if existing LL is bought up, Is that the company gets revenue and gets more financially stable , they would get more consideration in partnership talks with a BP and could get new trials done .
No matter what happens, Cytodyn will have to complete new trials
Wow, the shorts have a new strategy for CYDY. Convince the longs to help them short CYDY.
All this in aid of getting rid of the one guy who opposed giving the company away to a BP for less than a dollar a share.
I guess BP still wants this for less than a dollar a share.
I say as i have said all along, grab the international markets earn revenue and then take the time to construct, and execute trials with more then 500 participants so that results are unassailable.
At 4 doses per patient you are saying the Philippines only has 2500 cases ?
They have 109 hospitals at let's say 20 ICUs and their hospitals are full as it has been reported in the news, that's 2000 ICU critical. People waiting on ICU could easily be double that.
That could empty out the ICUs but then they would fill right up so 40,000 doses would last 1 month , I think 100,000 will get them through this intense wave.
Pretty sure they are still going to do CD16/CD17.
CYDY submitted the modified protocols and are waiting to hear back from the FDA.
NP said they would be enrolling more international patients since Covid is not as prevalent in the US as it was.
It may take a little more time to get hospitals set up for trials from Brazil and Canada.
In the US Covid is on the upswing in some states so some enrollment may be different between the Hospitals in the US, possible the FDA is even slow rolling the next trials .
There may be pressure to partner with a BP. Hopefully they can work something out.
Thanks for the heads up. So far been a normal day for me.
See what happens tomorrow.
The wife got Pfizer and was down for a day and a half after the second shot . She was back to normal after about 3 days.
I got my J&J shot this morning. So far no effect. Not even soreness in my arm
Yup, only 1 in the world that can have a critically ill Covid-19 patient off of mechanical ventilation in a few days.
But, hey. The FDA has our back here in the US .
Those floodgates are slowly opening. However, once they are opened up the shorts will have only 1 argument
" If it's so good, why isn't it approved in the US ? "
Unless of course, they license or partner with a BP in the next month or two
This isn't a trial , they just want to save lives. They will give it to the sickest who have no other options.
This is where LL has an opportunity to shine , they are not holding back on doses and the reason people will pay the higher cost , get their loved ones better and out if the ICU quicker.
In case you missed it. They just sold 28 x 4 vials of LL. When that is shown to work there will most likely be a new set of CSP sales.
First 1 patient
Then 1 Hospital
What happens when that hospital clears it's ICU ? They never buy again ? No, they will fill the ICU quickly and get new CSPs for more patients.
This is a test to decide whether they buy the 100,000 doses. It may take a few more, they may run through the first 100 patients this way but it will certainly ramp up.
The Philippines seem to have a more common sense approach then the US. If it works, they will use it.
Good post.
I agree with you, NP despite what people say, has an honesty that he cannot contain very well. The " I've got a secret " runs strong in him.
I was wondering about the whole New York thing.
You usually meet in person when you have to negotiate, then sign papers and the signing needs witnesses and it all has to happen asap.
NP said something interesting when he commented that shareholders want EUAs everywhere then went to the current supply of LL which might be enough for one Country.
In past CCs he has stated that they will manufacture as much LL as is needed, yet there was a change in his attitude about being able to meet demand that was not there before.
Janet Woodcock has mentioned in the past that she favors BP due to their ability to get drugs past the finish line and ability to manufacture.
So, could it be possible that a back room deal may have been favored by the FDA before approval for Covid19. A deal that will increase manufacturing capacity exponentially ?
NP spoke about the meeting with the FDA about Samsung Biologics with Nitya Ray. He was giving Ray lots of kudos and kind of drifted off at the end almost like he was saying too much.
Perhaps there is something very large in the works, as he basically said that more then half of existing LL being reserved for Brazil and Philippines.
I agree that we appear to be headed for some interesting times.
I seriously do not think that NP and SK and others would sell the company to a BP for a price that a BP would be willing to pay.
Two conference calls ago, SK had mentioned that they had interest from some entities in partnering or paying for trials.
This indicates a willingness by some BP to invest or partner in an indication. My opinion is that they may license out LL with a BP for an indication.
I suspect NASH may be the one or LH, possibly even HIV. They did not want to talk much about HIV but kept repeating that they would address it in the next update
NP and SK see Cytodyn becoming an Oncology company in the future but they have to survive to get there and this could be the way to accomplish that.
That is correct, many are saying the Brazil deal is equivalent to the Chiral Pharma setup in the Philippines.
The two Countries are very different, the number of deaths is the big differnce, 1 week of deaths in Brazil is more than the 1 year total in the Philippines.
There is a massive need in Brazil compared to PH.
CYDY needs to start and complete the Trial in Brazil to get a big buy and consequently a big treatment sample in Brazil that will undeniable show its efficacy in treating critical Covid.
Treating 25,000 to 100,000 in Brazil will show the world who the leader in Critical Covid19 is. That will be Leronlimab.
This will put the pressure on the US FDA to approve and at the point that Cytodyn becomes financially independent, BP and its FDA serfs will have lost their battle to contain Leronlimab.
Like I said before, I hope it is a separate Trial and can start soon, it will be completed and Cytodyn will be selling in Brazil before CD16/CD17 are fully enrolled due to delays by the US FDA.
Someone on Facebook has reading comprehension problems
It says specifically that they committed to trials in all current indications for Leronlimab and has Longhaulers Covid-19, Nash and Cancer listed.
No HIV..
With high demand hopefully they can enroll quicky .
Misiu143 , that is a good question for the CC. Are these trials in Brazil related to the trials in the US or fully separate?
If CD16/CD17 will be enrolling in Brazil , Canada and the UK in addition to the US is fine, but they need to get started soon.
It seems the FDA is slow rolling Cytodyn due to the improved chances of new LL trial success. No decision on EUA and no decision on new trials. 1 month down the drain.
It would be better if the Brazil trial is separate. Hopefully faster enrollment with no US FDA interference.
That's funny because the discussion about all these negatives was initiated by yourself
Not new , Robert Was on the advisory board since way back. He used to work at Karma Auto which was the failed Fisker.
The only sign of life has been Sidlo making videos for everything and everyone. Maybe he is bored.
There was one that looked like an XNRGI video but no branding. Showed a Tesla Factory.
Maybe XNRGI will pop out of its Coma, but not likely . Been 4 years since it went dark.
Last year they claimed to have a factory, there was a vague partnership with a solar company from the UK for telecom micro grids. Probably fizzled.
Got sideways with Petrovic who did not appear to get replaced.
Yeah there is no agenda with every post negative about Cytodyn.
Claiming " im not short " in my opinion if it walks like a duck and talks like a duck, its a DUCK !
All these simultaneous lawsuits and the constant PR's posted by the various Law Firms point to a coordinated effort in conjunction with Hedge Funds shorting.
Now, it is possible that Hedge Funds short a stock and all these law firms see it and jump on, however since this seems to happen over and over it seem more like a team effort.
This happened 3 months ago with TRQ a copper and gold miner. There was a Hedge Fund that went after them shorting and putting out reports then the concerted Law Firm Law suits with investigations and class actions. It is very easy to see, just go the TRQ in Yahoo Finance, go back 4 months and see the multitude of PRs from this same group of law firms then BAM the PR blitz just stopped.
Of Course, the TRQ stock price is up quite a bit from when they were gang attacking the stock.
Oh, so just pushing the get rid of NP platform ?
Sorry Bubba, the old owners and management before NP could not get CYDY to the starting line, much less the finish line
New management would enrich themselves and their "wink wink" investors by robbing current shareholders .
They are not even doing that. Do you you notice how they continuously post PRs in order to drown out positive PRs on the news pages on various platforms?
It is a tactic to scare away potential investors by creating a negative impression for people who see CYDY stock up by a good percentage and click on the link to see what CYDY is about. Looking at the News all one would see is Lawsuits.
They constantly post PR notices about the lawsuits to drown the actual company news PRs.
Right right, push the new management agenda so that other people rather than the current shareholders benefit from the success of Leronlimab.
new management would Reverse Split this then dilute by selling to their Cronies and shift the ownership of Cytodyn to a different group than the current investors. NO THANKS.
If they wait, there are many shorts who will be in that position .
Unfortunately all the FUD they are trying to spread will be proved wrong.
There is an Elephant in the room that is much bigger than the small ceramic statue the shorts are pointing at.
When Cytodyn sells a Billion dollars worth of LL in a record amount of time, and has to start Manufacturing more any argument these law firms can muster will be seen as what it is. FUD .
Surely you understand the difference between being on High Flow Nasal Cannula, being on a ventilator and being on ECMO.
Those are all various stages of Severity going into Critical and finally End of Life.
Once the patient on HFNC doesn't respond they are on their way to a vent and likely towards death.
Leronlimab works at all stages and better earlier but when given later that is when a patient will require more doses.
Ya gotta keep it real.
First they reverse split the shareholders , then they diluted them.
It's like a super double blind placebo scew over for those shareholders at HGEN.
I am hoping that is the protocol they are trying to amend. A Phase 4 confirmatory trial accompanying EUA.
The strange thing is they mention a Trial and enrolling in the UK, Canada and Brazil.
This begs the question of how many hospitals in those countries would be participating. It also begs the question of what trial they are addressing in the PR.
A phase 4 confirmatory trial with EUAs in the Countries mentioned ? This would be the best case
Or CD16 and CD17 modified to 4 doses ?
NP mentioned 25 Hospitals in the last CC this was before they spoke to anyone in Brazil. Maybe that was including the UK since they were going to include them in CD12 but did not. Adding Brazil and Canada would greatly speed enrollment if doing CD16/CD17 .
Too many variables that need resolving hopefully with the next CC.
I hope not. I would like for them to cover about a week after the good news is released.
Hopefully they can stay negative and keep trying to short as the Stock price rises and finally capitulate after we hit $10/sh.
Unfortunately everything is clear as mud.
They filed a new protocol, great . A protocol for what ?
Are they modifying their EUA request ?
Are they modifying the treatment protocols for CD16 and CD17 ?
Are they modifying the treatment protocols for the OLE on CD12.
This is the frustrating thing about this company, they don't just come out and say what the current situation is.
It will take an hour long CC just to decide this PR.