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CytoDyn Inc. (CYDY)
Other OTC - Other OTC Delayed Price. Currency in USD
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164,742 reactions on $CYDY conversation
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There has to be a time when you have enough anecdotal evidence , both efficacy and safety, that trials can be shortened or ended regardless of what the company defined as primary endpoint(s) ..until then we will continue to see deaths mount up for many sick patients with various diseases . The bureaucracies are tough to change and it’s sad to see we have passed the 700k death rate in the US.
According to new video this morning from CDC Philippines, the 1st Leronlimab infusion hospital has been approved, several other hospitals either stocking Leronlimab or r in the process! News of the Doctor being saved will only increase the exposure for Leronlimab!
This group of doctors in the Phillipines said they were looking into establishing an infusion center over three weeks ago. Now they have it. Amazing progress over there. Even more amazing Doctors. There will be a day, I believe, where they will all be appropriately recognized. Looking forward to the fruits of their labor.
Dr. Randy Nicholas - minute 45:40 "None of the patients developed Long Haulers symptoms" The boom is coming....
Boom Boom Boom, Dr Home Lim near minute 35 states this".....the biggest thing that really helped him......that shifted him to become really better was actually leronlimab ..... with just 2 injection of 700 mg, then you could see in 36 to 42 hours, then suddenly became better, and that is what happened....very consistent with everyone who was given leronlimab......it has saved so many lived......will improve survival of your patients".
Agree with Rod's post below. The continual harping on NP's salary is unwarranted. In my view, he has earned it. I don't begrudge him at all. Has kept the molecule out of the hands of those who would sell it off cheaply or bury it. Took it from 5 cents to just under a billion dollar MC, without an approval. He has been a steadfast advocate for invested shareholders.
Those that are familiar with BT investing know that this space faces unique challenges. A regulatory environment that is built to preserve the status quo. A social media environment that enables proxies of the status quo to continuously spread malicious lies and half truths about Cytodyn, it's executive team, and the drug itself. A securities OTC environment that enables dark money and naked shares to keep the SP artificially depressed. The 10+ year nature of any drug development effort. The tremendous amount of money that is required to navigate this development cycle.
The only question you need to answer is this: Does Leronlimab work? If you believe the answer is yes, then you are holding if you're long, and you should be buying now if you don't already have a position.
Plan to hold for years. The tremendous number of indications that leronlimab can help address, either directly or as an adjunt, and to do that SAFELY, is simply jaw dropping. The big win will go to those that are patient and willing to not sell everything once it's up 500%, but those who are willing to wait years. I'm in that number. Are you?
In a country (the only one, for now) that is allowing the use of Leronlimab, why would SO many of the countries "VIP's" AND prominent Gov officials be putting their lives at "risk", choosing to use Leronlimab over other drugs?!
Even over FDA Approved drugs?!
Why not choose to ONLY use Regeneron, Remdesivir, Ivermectin, or Dexamethasone, or Hydrocloriquin, or Moravoroc, or Vitamin D, or Zinc?!?!?!
BECAUSE - these VIP's are seeing, by larger & larger numbers, that L is working & saving lives - even & especially at the dangerous Severe AND Critical stages of Covid - like nothing else is!!!!
This last VIP, a well known National Doctor, just released on Thurs from the hospital thanx to L, may just be the spark we need to jump start the orders for L, & some type of Philippines approval.
Larger & larger orders had already began to flow in from the Philippines!
And we are only at the very beginning!...
Sec. Greco Belgica earned Master's degree at University of California at Berkeley. Over 4000 views. Who produced this video. It's great. Well done.
What will a leronlimab infusion center look like? Some exam tables. No IV's. A large post waiting room, to monitor for adverse events (there won't be any) before being released. An appointment desk to schedule your next injection.
Philippines will be the first iteration. For COVID. Now imagine infusion sites for multiple maladies in the future. Think Davita for diabetics. But unlike Davita, you own the molecule. Yep. Gonna happen. If you're patient. See you in 2025.
It’s very clear that the next six months is an interesting time for Cytodyn with multiple opportunities get regulatory approval and/or breakthrough designation. Putting everything else aside if this is as amazing of a molecule as many of us believe, the Brazil trials (and possibly US critical) may show this with unrefutable data, the NASH trial may knock it out of the park, the cancer data may obtain BKD, HIV BLA may be filed and monotherapy approval in process, Long Haulers may show a successful next trial, and/or Alzheimer’s and or stroke may yield positive results. Valuable will either grow significantly and they uplist to NASDAQ or none of these come to fruition and SP plummets. There’s also a possibility that DOJ, SEC or investor lawsuits could have legs but I’m not overly concerned about that scenario. Status quo is not an option.
Given this, I believe that any additional distractions to management who I do feel is busting their butt is not value adding. We also need to give them the runway to succeed by approving the additional shares and BoD. This is time to support current leadership and stop the nonsense.
In a year, they will be wildly successful or they will be voted out. And if they are wildly successful, they will possibly get bought out or I believe there’s a good chance they will get both big pharma chairman and a big pharma CEO to take things to the next level. And, frankly, I think fundamentally, any potential to change out current leadership through the 13D effort has been fully thwarted (which I believe is a very good thing), investors need to decide if they want to ride that journey or cash out now.
NP is not perfect….not by a long shot. But I am 100% confident….not a doubt….that he is passionate, he is resiliently optimistic, and he legitimately wants to do right for investors and for the world. He is also a deeply religious man and takes great solace in the fact that due to his and his team efforts many lives have and will be saved. I still believe he is the right person for the job right now. And right now…the next six months…is really what it’s all about.
All, the frequent negative posts…be it shorts, angry 13D’s, CEO’s of big pharma, Dr. Woodcock or those with multipersonality disorder constantly harp on such items as the HIV BLA being missed or Brazil trials taking longer.
There’s a price of entry for the transparency that the Cytodyn leadership team is providing. NP and team is providing forward looking dates as they want to keep investors up to date. They don’t have to. They could have only decided to announce the BLA when it was filed, Brazil enrollment when it was met, NASH results when they were finalized, etc. They could do what a lot of companies do and not provide any or only minimal invite into future events. They could not say a word about the Philippines meeting potentially in two weeks, the NASH initial results possibly by end of November, or even the updated details of the HIV BLA timeline.
That’s just not NP’s or Cytodyn leadership style. They know that the high number of investors are retail that want information. And they are providing what they can as early as they can in a lot of cases.
Your price is to where the big boy pants and understand the information is future looking and will not change. The shorts and bathers will harp and moan and make every slippage a big deal. Your mission is simply silence that noise….
They have no good intent. And whether or not they are a paid basher I have no idea…but they are not in this for you.
By the way, I am not a paid promoter but please, please make me an offer.
I don’t post here often but when I do it’s time to celebrate, the Dr. Phil of the Philippines saved by Leronlimab! Cheers 🍻 to that on a Friday night after a long wk. !
35min mark for those interested in LL.
GRECO BELGICA Covid 19 Survival Story Video
If you recall over the past 2 months, people would be sharing screenshot of trial sites approved by ANVISA with a circle stamp in black lettering on the webpage. We were all excited when we are viewing these notifications with the assumption that ANVISA is moving quickly in getting these sites approved for both trials with notifications coming every week. We have to remember that there is a gap in time from when ANVISA puts their stamp of approval on clinical site locations and when the location itself actually starts enrolling patients. After yesterday's call...a number of shareholders were upset about enrollment being slow (20-25 patients) in severe trial and (none) yet in critical trial. The reason is the GAP between site approval and going live. There are action plans/protocols that need to be done for each site in order for the site to begin enrolling. THIS IS THE GAP. Brazil should have more sites actually going live by beginning of next week. (Hopefully another 16). Shareholders are frantic about Cytodyn missing the COVID play because of a strategic blunder by NP via pursuing trials in Brazil due to slow enrollment. Enrollment will increase as sites become LIVE. COVID is not going anywhere anytime soon. Why get upset. We currently have 4 sites active with about 25 patients treated and more to come. I am very confident that the first critical patient press release will be announced at the latest by October 27, 2021 (eve of shareholder conference). Cytodyn is even going back to the FDA to submit a critical trial protocol as well. As a shareholder, we realize that if we see these trials through...it will be a success. I don't want to have any regrets in the back of my head if Cytodyn simply gave up on the COVID play knowing that this company clearly has the best drug in the entire world to treat this disease.
A strategy that I do for myself is whenever NP gives a timeline, I internally double it. It keeps me centered mentally about my investment. A realistic expectation for me when it comes to Brazil is I believe that the severe trial will have to go the distance by enrolling all 600+ patients + another 60 days to finish study and provide data readout which should happen by late April.
As for the critical trial in Brazil, I think we could get results by end of quarter 1 of 2022.
I can't make a comment on US just yet but I do believe a protocol will be submitted for this by end of October (hopefully announced at shareholder meeting) or very early November at the latest.
Patience.....the mountain is high...but the climb is worth it (However hard it may be).
By the way, I do have a quick question.
If the BTD application for mTNBC is submitted by end of November, how long will it take for FDA to schedule a meeting with Cytodyn to discuss?
Ok. We have shed the 13D takeover bid. Now that that is past, and the time for idealistic rhetoric is over, the 13D struck some chords and got some support because some of what they are saying is true.
We need independent review and guidelines for compensation. I don’t care what people get paid, I care that it’s fair, that it’s in line with what others make for similar jobs, and that incentives are tied to complete and successful execution, more than milestones.
I do agree with the desire to find the shortest path to success and drive it to completion as quickly and with as much focus and professionalism as possible. Developing additional indications and starting new trials should be a distant second place and should only be from excess cycles. Everything that can be done to advance the number one objective and make it certain should be the target lock.
And we need clarity and blunt truthfulness on that objective. Not wishes, hopes and spin. Give it to us warts and all. And if we change objectives, be clear about that, with reasons.
Haven’t had a chance to watch the video - anybody know which protocol they used? Was it 4 dose sub-q or did they use IV for any of it?
Would be interesting the number of vials to the Phillipines, if we new the PO amounts we could extrapolate the number of patience treated. Hope Chiral is on it.
BTD application for mTNBC will be finalized in October.
NASH topline in December
Phase 2 long hauler protocol submitted to FDA
Phase 3 200 patient critical Trial protocol will be submitted this month to FDA as well right before cold weather hits. Hopefully, an interim analysis around 130 patients would be golden.
New CRO's about to be announced.
Philippines meeting with Chiral hopefully in 3 weeks hopefully to increase revenue strategy.
Severe trial site are recruiting patients during beginning of warm season in Brazil with up to 16 more sites going live by October 18th.
CMC and Non-Clinical HIV BLA portions submitted by Thanksgiving weekend.
Critical Trial in Brazil should be dosed before annual shareholder meeting. We should be updated by end of this week or beginning of next week.
Remember, it took 37 days between severe trial being approved by ANVISA and first patient being dosed.
I see same time in days separation in critical trial. Forecast = 1st injection by October 27th at the latest.
We will get there despite the thick mud we are walking through right now. It is all progress.
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