"Heck, even I chatted with the CEO yesterday,"

So, without revealing anything specific, stockorus, an you tell us if NP sounded optimistic or particularly upbeat? Did you detect any frustration in his voice? If so, maybe he's just a Packer fan. Or maybe it's something more; can you tell us anything without violating his trust?

Very sorry to hear of your extended-family losses, Data Science, I can't imagine the sadness/loneliness those fathers/husbands left behind. I'll keep your India relatives in my prayers.

You're on fire, Learning53! Whatever the election, you have my vote.

Excellent find, BBalls! If anyone has any connection to Senator Rand Paul, PLEASE forward this letter ASAP. I believe Sen Paul (or any other Senator/Rep with MD cred) would be the best person to slay the Fauci/Woodcock/ FDA dragon, they just need the right Weapon, and LL is it!

Thanks, Dr. M! Last Question: Is there any ethical or science-based reason - any at all - that the FDA would order Cytodyn to treat COVID patients and run their studies with only 2 doses of LL?

I mean, if we have years of the sickest of the sick - HIV patients - who survive just fine with no SAE's, I don't see any potential safety issue whatsoever. True?

Good Evening, Dr M! Quick question: when do you think we'll see results of the 28 patients who were given LL? And do we know for a fact all will be given 4 doses...even if some of them might show quicker improvement?

Thanks!

Looks like LL got some credit for saving the ex P.I. Prez:

I saw this link on the YMB from JWR:
https://www.philstar.com/pilipino-star-ngayon/showbiz/2021/04/27/2094028/erap-gumaling-sa-gamot-ng-hiv-infection

I looked for Leronlimab, and when I saw it, I ran the paragraph through the translator, and this is what it says (boldface mine):

"Again, thank you all, !!!" Erap had many excited and gratefully recovered after having A COVID.He's been four years old. Leronlimab is said to have healed a former president who allegedly tried to leave the chief executive, P1 million.Yup, it alleges expensive. But if it's good, what is P1 million, life has been saved.I heard this mentioned by former Sen.Jinggoy in Karen Davila's program at the ANC."

Hopefully this reads better in Filipino.
More hopefully, let's get some great news tomorrow!

Great post, 3x, thanks for sharing this kind of content!
It does leave me with a couple questions, though, namely -
1. Haven’t other companies been allowed to change their endpoints during the study? And
2. If CYDY has the freedom to design their own study, how come the FDA told them to use 2 doses, not 4?

Massive unaccountable bureaucracies like the FDA and IRS are the biggest threat to good government "of, by, and for the people."

Unelected officials can't be fired and can't be sued and have no competition. This is the antithesis of free market efficiency, and the fallout of their decisions/lack of decisions has and will continue to kill.

In America, it wasn't supposed to be like this.

Attn: Dr Misiu, Dr Rock, and other MD's/smart guys.

How much credence, if any, do you give this National Library of Medicine study that suggests the Pfizer vaccine may do more long term harm than good?

https://recentlyheard.com/2021/04/22/report-pfizer-vaccine-causes-neurodegenerative-diseases/

Thanks to crazyjogger for the find!

Great info, Latane, thanks! Question: Why do you think the Philippine FDA would 1. approve the drug for 10x the number of patients (used to be 28?) and 2. approve the stocking of LL in hospitals...instead of just coming and approving LL to be sold?

Why the piecemeal approach; is it just the typical "overly cautious" behavior of a bureaucracy?

Then again, we didn't see much overly cautious slow-walking in the US with remdesivir or blood plasma.

I wonder how much clout American BP has in the Philippines.

Good Morning, Dr Rock! Here's my ignorant question for the day: why is receptor occupancy so important - if the end result (successful treatment of AIDS) has been achieved? Why do we (the FDA) care so much about RO?

Thanks for the kind words, Niknak1! Still curious about "how" you found out about CYDY 14 years ago; was it a personal friendship with NP or someone else in the company? No need to answer if it's personal, just curious.

I've been in CYDY about 1 year now, and I wish I was one you sub 50 cent buy-in guys, I'd be waaay ahead. As it is, most of my investment money the last 10-12 years was tied up in CTSO, a blood filter company that was aimed at stopping sepsis. It's a great product, but the SP just never took off, and while giant companies like Whole Foods and Tesla went on incredible runs, little CTSO just kind of stagnated.

Not good for the 401k, and I was happy to find CYDY per the recommendation of another CTSO shareholder last year. The first day I found CYDY, I bought 11,000 shares, and have only been buying since.

Hopefully, good things coming soon! I moved a large portion of my CYDY into a Roth last year, and since that was treated as income, I'm hoping for a double-digit SP before May 17th! Good thing I'm not a financial planner.

God Bless you and Good Luck, may LL save lives and retirements as well!

Nice work as usual, Diesel! What I find interesting on the Canadian status page is that - of the 15 drugs listed? - the only status is either "Authorized" or "Under Review."

Now, maybe it's just that every "Rejected" drug has been scrubbed from the list (I didn't see anywhere if that is normal procedure), but if not, then...maybe to even get to an "Under Review" status means that the drug has a VERY HIGH chance of being "Authorized."

I have a feeling next week that the levee might finally....

Great info, BBNCT, thanks for passing this along!

I liked how the two college friends at Pfizer and Merck did not reveal any sensitive info to their long-time friend, that kind of honor/discipline is too-rare of a quality.

Re: the PR - I assume this means we are very close to making the sale, but no actual order has yet been placed?

Was this a "strategic" move by CYDY to push our own FDA (maybe other countries, too) to jump on the train before the initial supply runs out?

I see nothing but good from the PR, but I suspect there's a lot I don't see. Are we close???

Humble, I think Calstang's point was - per the FDA's own stated guidelines, all that "small part of a small study" evidence SHOULD BE enough when considering a completely safe drug during a pandemic.

The FDA is MIA.

Approaching Approval Beach in the CYDY LST, this is what I see:

1. Sen Rand Paul discovers Leronlimab and locks horns with Fauci and the FDA and slowly, surely, drives them back, while

2. Former P.I. President Joseph “Erap” Estrada thanks the doctors and nurses for his survival, then raves about Leronlimab, thus turning a flamethrower's heat on current President Duterte to buy a literal ton,
then

3. The other beaches start to fall: Brazil, Canada, Mexico...and eons from now, when the sun is but a flickery crisp, even the USA. The suicidal ghosts of Big Pharma's FDA will fight to the last, but Naders Raiders prevail!

Cue God Bless America,

Fade Out.

Do you know if anyone has contacted - or has some connection with - Sen Rand Paul from KY? Of all the Senators, he strikes me as someone who could not only understand the science of LL, but also not be intimidated to turn up the heat on the FDA with some probing questions.

Anyone on the board from Kentucky?

Good Afternoon, Dr M! 3 Questions:

1. Do we know what date those 28 patients in the Philippines will receive (or have received) their first dose of LL?

2. Based on the other 2 patients in the P.I. who received LL and recovered, do you know what sort of expectation we should have on "how many days after the first shot of LL" to expect news on how they fared?

3. Selling to the P.I. or Brazil or any other country before the USA approves us - could that turn the FDA against us for our future submissions for cancer, NASH, etc? Could the FDA be that political/petty?

Excellent post, House, I appreciate your Big Picture perspective!

Question: This HIV BLA hurts my head, I don’t know why it takes so many years to get a life saving drug approved for sale if the efficacy and safety are the best in the world. Has Nader or Dr Kelly given us a revised expectation on when we will submit for the HIV BLA? And what does this portend for COVID 19; will we need a BLA to sell LL for COVID as well? Is that another 3 years?

Question: When the PR says "enable Biomm to sell leronlimab in Brazil following regulatory clearance," who's clearance are they talking about?

Is it Brazil's regulatory clearance? That's what I would assume.
But could it also mean USA's FDA regulatory clearance?

Agree 100% with your POV, PNW Ironman, stay on the soapbox as long as you want.

And FWIW, I think I just talked my 20-something niece into buying a position in CYDY, she's going to pitch it to her investment group tomorrow.

CYDY, the Carnegie/Bezos Club of the 21st century.

So frustrating to read stories like this - and realize that millions more just like her have no access to our TOTALLY SAFE drug. All the sickness and death for no reason, and no bureaucrat or agency will ever pay any penalty or price. In free market republics, other than defense and perhaps a few more, giant government bureaucracies like the FDA and IRS have to go. No competition plus no accountability equals misery and servitude.

GO CYDY, hoping for a great update tomorrow!

Great video, BB&CT, even I could understand it. Sounds like the two Filipinos in the video are sold on LL, I hope that have some persuasive clout with their govt health people.

Hoping for a lot of smoke and fire on pad 39A this week, LL to the moon!

Thanks, Closet! Interesting arguments on both sides.

To my ignorant point of view, though, I don't see how Dr P could patent a "treatment pathway." I mean, if Cytodyn didn't change LL in any way, how can you penalize the company if it happens to work against a new virus?

Granted, Dr P might have had the insight or recommendation to use LL against Covid, but I just can't see how you can patent a new application if you never alter the drug.

Seems like an Attaboy or a big promotion would be in order for Dr P more than a lawsuit against CYDY.

KC, if you are so inclined after you land - do you know the crux of the disagreement between NP and Dr P?

Just wondering what could be so divisive that, after so many shared battles and with so much at stake (financially and medically), why they couldn't at least professionally coexist until the first approval.

Question for the Docs and Smarts: Since the FDA knew how safe LL was a year ago (based on all the HIV patient data), how come - in our trial design - the FDA 1. did not let us start with an IV of LL and 2. limited the total dosage to two shots?

I'm not looking for a conspiracy, but if the drug is so incredibly safe - and knowing how much quicker it can help when administered as an IV - what was the medical rationale for these 2 decisions?

Is it not like a running a 100 yard dash with ankle weights?

Good stuff, Diesel, let's hope this dam against our super molecule finally begins to crack. The levee is high, but LL success continues to rise!

Mr Breeze, your

"Something is brewing in the witches pot and fools will be stew once we hear those magical letters EUA I feel the heat for shirts. Close the lid"

ranks (for me) as the best thing on ihub today, I nominate this for "Best Post by a Poster" for 24 March 2021, it even out-shakes your cryptic Japanese quake reference.

Good Luck!

So best guess, if 4 weeks for the FDA to reply, we're looking at approx 20 days for a possible EUA approval announcement, maybe April 10th - 15th?

And would this announcement possibly generate a sufficient SP so I could pay my taxes?

Yikes! It will take a day or two to give these links a thorough reading, 10baggerz, these sources run deep. Thanks very much!

May I ask your best guess on the most popular question, i.e. - when do you think they'll release TLD?

Hello, biosectinvestor, I'm a fairly recent investor in NWBO and my question is - besides the acquisition of production capacity in the UK, what is the best evidence that supports your thesis of "exciting" TLD?"

Appreciate your opinion(s).

Bureaucracies are corrupt. They are a collection of egos and fiefdoms and power grabs that inherently avoid risk and are perpetually mired in organizational trees and rule by committee to avoid responsibility. In the end, it's all about job security. Those at the top respond to political pressure from above, not the actual needs on the "battlefield" below.

The FDA is a large bureaucracy and is not responsive to market forces or changes in the medical landscape. FDA MD's and PhD's think very highly of themselves and know much better than others what should and can be done. Too much inertia, too many embedded relationships with the big pharma industry with skin in the game.

Bureaucracies do not serve the public interest, they serve their own. And that's why we have SAFE drugs on the shelf that take 15 years to get to market. People die, but a bureaucracy literally does not care.

I believe Breeze is talking about Tectonic events

Can we get Dr Rock and Dr Misiu to submit a few questions on behalf of the iHub board?

Thanks, Babubd, great summary! I'm a new investor this week and appreciate the info, very handy.

Great job, Monroe! I'm actually running pretty hard myself, the wife and kids have been chasing me all week yelling "Two bucks a share for saltwater? We coulda' had Tesla at $600!"

"Cool Hand Luke," 3X, and I'd like to exchange the gold star for CYDY shares as of 30 June 2020.

Nailed it, jimmy.