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Our Longhauler results will be the crack that opens the dam. When millions of people around the world hear about the one and only drug that can clear their brain fog and other lingering maladies, they will DEMAND to have it.
A few voices at first, then get some national exposure and not even the most corrupt medical bureaucracy in the world - the FDA, for those keeping score - will be able to hold Leronlimab back.
No competition for treating Longhaulers and their numbers will only increase.
Amazed our SP isn't headed north already, but when word gets out, and when we get our Phase 3 results, I believe our $1.70 will red-shift toward $100.
Thanks for sharing your view on the results, Dr Rock! I'm heartened by the positive MD reactions of Dr Misiu and yourself. Would also like to hear from the other MD's who post to this board.
Looking forward to the call today, and also to more of your posts!
Question, Dr M: Can the FDA do anything more in terms of demanding more frivolous tests to further delay our BLA for AIDS? Is it now just a matter of submitting the BLA package during the "accelerated" rolling review process?
Nailed it,Learning53,100% agree.
Nothing like Leronlimab, it's potential and safety and ease of use are unmatched.
It IS the prize.
My take is - the FDA has one mission.
One job.
Approve drugs that are safe and work.
No dumbing down required, no trophies desired, Cytodyn is responsible for submitting a safe drug that works.
And the FDA? Why they give a damn about how many PR's a company spits out or the size of company's payroll or the personality of the CEO - THESE DON'T MATTER to someone suffering or near death. This feckless, cowardly FDA has lost sight of its mission.
And yes, it IS that simple.
EVERYTHING Dr Lalezari says on that 5 minute podcast snippet is an indictment of the FDA, NOT Nadar P or Cytodyn.
Are you kidding me, FDA?
Your only job is to HELP SAVE LIVES, and you slow-roll a SAFE, LIFE-SAVING drug because 1. You're not familiar with it's MOA or 2. Cytodyn only has 22 employees or 3. You don't like them putting out as many as two - 2! - PR's a day?
Every FDA bureaucrat who purposely slow-rolled approving LL for AIDS or COVID that resulted in needless suffering and death should be put on trial for manslaughter.
These bureaucrats have 1 job - ONE - and that is to ensure the drugs Americans use are safe and effective. Any other consideration is MOOT, and if the FDA doesn't get that, they have no reason to exist.
My contempt for these bureaucrats grows with every revelation.
http://lalezari.s3.amazonaws.com/lalezari.mp3
3 Questions on Today's PR:
1. Was anyone else surprised the results of the Phase 2 are already being released? I was expecting early July.
2. Do Phase 2 results typically have much effect on short term SP? Even if they look strong, won't the FDA still require a Phase 3?
3. Is it an SEC requirement that a company announce Phase 2 results?
Hoping for a Monday liftoff, the line starts at pad 39A.
Just read this on reddit/CYDY. Instructive and hopeful!
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From "u/upwithstock":
HIV and LH market
As I have stated before about a successful BioPharma company; success boils down to three things: 1) Good data 2) Regulatory approvals 3) Revenue generating distribution. We are close on COVID outside of the U.S. I am confident that CYDY will begin to see some sort of approvals from different countries that allow them to generate revenues: Philippines, Canada, India and Brazil with more on the way. But, I want to draw your attention to HIV and Long Haulers.
In the U.S. we are moving closer on two indications that are at different stages but represent very large markets; 1) HIV and 2) Long Haulers also referred as PACS. As most of you know CYDY and n-particular Dr. Recknor are filing the corrected BLA in July. If this gets accepted by the FDA a PDUFA date will be scheduled out approximately six months later making January/February 2022 timeline for final FDA review/approval. Synthesis 1 has CYDY's market potential listed at $14 billion and that was conservative.
Number two and much bigger is the Long haulers/PACS market. Scott Kelly estimated 20-60 Million patients world wide. Not including the new variants that are circulating. Nonetheless, if you assume that Leronlimab treats 10 million patients (assuming some folks can't afford treatment) at 8 shots per patients (LH Phase 2 protocol) at $1K per shot that would be $8K per patient times 10 million patients and you're looking at $80 Billion. This easily would put CYDY in the top three Pharma companies in the world just with LHers.
I am not selling !!
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Agree with you 100%, Doctor, thanks for your service and perspective!
And yes, I really hope the Alzheimer drug approval/fiasco brings some scrutiny to the double-standard/BP-driven policies of the FDA.
No reason Leronlimab should not have an EUA.
None.
Dr M, I'm going to have to agree with DollarBillYall on the panel's reaction to LL. To me, it looked like the moderator (in the middle) was checking the time; and when he saw he didn't have much left, he pushed the discussion to the "summary" portion. And the doctor and scientist (his guests) seemed to have a VERY positive reaction to the mention of Leronlimab...and seemed to indicate they knew how much the FDA had unfairly kept LL from EUA and approval.
That was my take. But I do think it would be a great thing if we could get these same guys to discuss LL, maybe get Bruce Patterson to join them as well.
WOW!!! Just saw his reaction to the mention of Leronlimab, his body language says it all! They KNOW how effective LL is and they KNOW how LL has been needlessly and wrongly suppressed by the FDA. We have to try and get these 3 guys to discuss LL on video!
Do you think you can contact them Dr M? You and perhaps Dr Rock or some other MD's? They might listen to you, and THAT would be a VERY IMPORTANT video!
Thanks for listening and giving your opinion on the video, Dr M, I found it extraordinary. And I'm barely at the 2 hour point!
This should be watched by as many as possible. So many things wrong with our bureaucratic centralized gov't medical entities, so much needless death and suffering with COVID 19.
Bottom line, Dr M, I think everything you've been saying on the iHub board is being proven to be true, including your recommendations on taking HCQ with zinc and Ivermectin.
And then we have the disgusting/1984ish role our social media platforms have played - and continue to play by suppressing the free flow of scientific facts, discussion, and reports. Incredible how such technicall savvy people who think of themselves "doing good" can be culpable for so much misery and death.
The whole COVID 19 mess stinks, from the Fauci gain of function seeded research to the CCP lies about its origin to CDC/NIH/WHO preventing safe, proven drugs from being given to the public...the list goes on and on.
Wow. If any MD or science-oriented person or just anyone really interested in what's going on with the COVID vaccines and their development, this is an excellent, fascinating, behind-the-scenes look by 3 very distinguished PhD's/MD's:
Excellent points, Bourbon!
Combine this with all the Fauci/NIAID/NIH/WHO collaboration to discredit the cheap/safe early stage COVID treatments of hydroxycholoroquine and ivermectin and all we see are scandal at the highest levels resulting in mass murder.
If not for the email (and other) evidence, this would sound like a B-movie sci fi from Asylum.
Keep up the great posts!
Excellent summary, Mets, clearly stated and factual. Thank you!
Good summary, Dr M! Also, if we keep getting revenue, and if it's "decent," we might also see a move to NASDAQ.
Lots of nice possibilities on the near term horizon (by 1 Sep).
Would love to see a bolt-out-of-the-blue buy from India or Canada, but I think our long-hauler results, if they're what we think they might be, could be a bona-fide, worldwide gold mine.
$10 by June 30th!
Great post, Learning53, thanks for all your insight and enthusiasm!
I think our CYDY June of 2021 is parallel to - NOT comparable to - the allies on the D-Day beaches of June 1944. In short, we've got heavy resistance ahead and no way back, but with our first reported revenue, we're gearing up for breakout, our drive to a victorious end.
Dismissed!
FIRST COMMERCIAL SALE is worthy of a drink or two, CONGRATS to NP and Cytodyn and all shareholders!
Even better, CONGRATS to all those Filipinos w COVID 19 who may get a new lease on life!
Anyone have a way to contact Dr. Randy Nicolas in the Philippines?
His last youtube video was posted about 4 weeks ago, so I wonder why he's gone quiet. No news? Pressure from above?
Strangely silent.
If anyone has Twitter, I would like to see if he responds to a request for updates or Leronlimab news.
It sounds like you believe the FDA's problem with CYDY is its CEO.
That may be true.
However, given the BP source of much of FDA's funding - given the backgrounds and revolving door careers many FDA bureaucrats have with BP - and given the eviscerating hit to BP's revenue that CYDY could potentially inflict? I think a much stronger case can be made for the FDA slow-walking and no-walking our HIV and COVID EUA approvals boils down to $.
Meanwhile, the suffering and dead be damned.
3x - Regardless of who's intel on NP's leadership and capabilities are correct - and I'm not saying NP's performance can't be critiqued - it seems the much larger concern is the FDA.
I say this not as someone with any knowledge of FDA or test/trial procedures, but as someone who sees LOTS of highly respected doctors and scientists putting their reputations on the line when they call out the FDA for moving the goalposts, double standards, 2 injections vs 4, etc - and all of this during a pandemic.
In sum, if it makes perfect sense to someone like me to grant an EUA to a drug with zero safety issues and tons of upside - how can it not make sense to the FDA?
The only way it can't make sense to grant an EUA during a pandemic is if other consideration$ trump saving lives. And that is not an NP or CYDY leadership issue, that's on the FDA.
Hello Black Ops and other stock pros, can you use some small words and tell me what today's 8k portends?
Potentially good or bad, best case and worse?
Thanks!!
I agree many politicians are worth our disdain. However, I still think Rand Paul and Ron Johnson and a few more are straight up. Rand will lock horns with anyone, and as an MD, he does not stagger before Dr Fauci's radiance.
I would also encourage anyone/everyone to write their elected representative, because I don't for one second agree we should "respect" the FDA to the point we're afraid to "bother" them with our concerns and complaints. They work for US, they are not to be feared, and if we surrender our free speech to a gov't bureaucracy, we'll lose our country as well.
Yes, really.
Howard, 2 reasons why I don't get the FDA:
1. Lack of Consistency (Favoritism)
They have a higher evidence threshold for LL than other approved drugs
2. People are Dying
Prior FDA statements to the contrary, they let people suffer and
die despite the availability of LL, a completely safe drug that shows
strong indications of efficacy. For severe and critical patients in a
pandemic, THAT should be enough.
You're right, PNW Iron, the FDA - in theory - works for us. And if we the people think their decisions are biased and wrong, we MUST call them out, moreso when their decisions kill people.
But they act like imperial royals because, in a real sense, they are.
They rule us from the heights of bureaucracy, and just like the madman in N Korea or Arthur in Camelot, they answer to no one. They obfuscate and obstruct and lie until people die, but no bureaucrat ever gets fired and none go to jail. In short, they have no reason to listen to the science or studies or us, do what they want.
Because they can.
Ad astra, per aspera.
Just read where India lost 50 doctors to Covid in one day this week.
50!
And I just can't believe that they wouldn't ALREADY have an emergency approval for LL and at least a small supply on hand.
None of this makes sense. Completely safe, best drug in the world, but lacks a P value due to poor trial design and/or lack of competent trial oversight.
So many dead when they could have been saved, so many dead because Bureaucracy Uber Alles.
https://www.zerohedge.com/covid-19/india-reports-50-doctors-dead-single-day-covid-mortality-peaks
My opinion, NP is in this for the war, not the battle. The war hinges on on working with the FDA, not alienating them. COVID is just one of many approval battles to be fought.
NP's in a very tough position, his baby (CYDY) is being unfairly held back, but if he strikes back, he potentially sabotages CYDY's future.
Based on how CYDY's PR was worded this evening- will NP be legally constrained (on the call tomorrow) to only discuss the points made in the FDA release today?
Can he address other questions/issues such as sales and the status of the Philippines 28 treated last month?
An HIV cure would be of course be amazing, but you have to wonder - can anything be as SAFE as LL in treating HIV and COVID and cancer and etc? I'm no MD, but it seems safety has to be thisclose with efficacy in terms of what makes LL so incredible.
Great LL testimonial from YMB!
Don't know if this have been posted here but:
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From Stocktwits: Beckymucha wrote: Quote "this is an update from Miranda on FB. Tuesday will be 2 weeks since her last dose of LL.
I asked for an update:
I’m cooking lunch for the kids! They keep me busy. I play on trampoline and go swimming and mom it up! Now that I’m home I have 4 people helping me rest, but also waiting for my miraculous cinnamon rolls to come back, and for my body to match my new energy levels! I left as a zombie and came back “myself.” Tomorrow I have an interview for a teaching position for august. It’s downtown Austin, Texas next to the river! I’ll be able to kayak after work. Trying my best to be grateful for the step up I got. Sometimes I do too much and rest more, puzzles, and books, and snuggles, and pigtails, etc."
Sounds promising, doesn´t it?
Wolfgang (Germany)
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Multiply this times MILLIONS of LIVES and you have to wonder...you have to demand accountability from our FDA. Will anyone ever be held responsible for approving Remdesivir and blood plasma and not LL?
Great, thanks, something concrete to anticipate this week.
Hello, Learning, question: on the call yesterday, did NP say to expect a PR re: sales to the Philippines this week? Is that our expectation, or am I confusing opinion with fact.
Thanks!
Was Nader actually in the Philippines for the interview? If so, if he didn't just "phone it in," I think that bodes well. I don't think a CEO would fly half-way around the world for a TV interview unless he could work in some major face-to-face meetings.
Thanks for the summary from those who watched!
And an inroad to India would be amazing, it's incredible how miraculous this little molecule could be.
Nice find, Saxxie2! Just forwarded the letter to Sen Rand Paul. Would love to see him question Dr's Woodcock and Fauci on why they approved Remdesivir but ignore Leronlimab.
Anyone see this? "Most Vaccinated Country on Earth Closes Schools and Sports as COVID Cases Surge — 35% of New Cases Are Fully Vaccinated Residents"
https://www.thegatewaypundit.com/2021/05/vaccinated-country-earth-closes-schools-sports-covid-cases-surge-35-new-cases-fully-vacinated/
If these vaccination numbers are accurate - if 35% of people who get vaccinated are still susceptible to COVID infection? - I see two results:
1. The world is going to need literal TONS of Leronlimab, and
2. Once we start getting approvals to sell, CYDY at triple digits within 10 months JUST FOR COVID 19 is completely possible.
Another Famous Filipino Saved by LL?
Saw this on the YMB, here's the link:
https://www.philstar.com/sports/2021/05/05/2095842/pumaren-survives-covid-19-scare
I wasn't sure if LL is injected into the abdomen, but sure enough (see para #3):
https://nypost.com/2020/03/28/coronavirus-patients-taken-off-ventilators-after-getting-experimental-hiv-drug/
Thanks, Dr M! Follow-up question: Can the results of these 28 patients be used in any of our ongoing/upcoming studies? Or - since the patients knew they were getting LL - have they have been "tainted," i.e., they don't meet the criteria for double-blind inclusion.
Good Evening, Dr. M! Quick question: Do you think we'll be updated on the status of the 28 Filipino patients (previously treated with LL) tomorrow? Has a sufficient time interval elapsed to compile the outcomes?
Thanks!
Agree 100% about the need to increase the audience/pressure on FDA, all I want is for a fired-up Sen. Rand Paul to grill Fauci and Woodcock on double standards for rushed vaccines and iffy meds vs safe/proven Leronlimab.
"Have you no sense of decency, Dr Woodcock?"
"Have you no shame, Dr Fauci?"
"Oh, you don't? To Portland, both of them! Leave them downtown!"