Nothing you don't already know, Irish, but I do think a sale of our drug is possible in the next 60 days.

I believe it's possible because - despite the way CD-12 was populated and how the first PR's were written, the results appear to be exceptional...as in right now, we seem to have the best therapeutic in the world with the least side affects.

And if the virus gets worse in Brazil (as they go from summer to fall), I would not be surprised to see our first sales order.

Then who knows what other country(ies) might follow.

Good Luck, Irish!

Hello, SBFM, I just took up a small position here and am wondering, timing-wise, when to add to it.

Any expectation on when the mice-study results might be announced?
Any other possible events/catalysts in the next 30 days?

Thanks!

C-20 and jimmy667, thanks both for your excellent and well reasoned posts.
Combined with a thorough review of the actual results and I think there's no holding us back.

LL WORKS!

Amazing Reddit piece, Professor, thanks for posting!

If this poster got his analysis right, this is incredible confirmation that we have a COVID killer.

It also makes me think/hope that - if the right people in the UK/Canada/Brazil/PI etc see this data, that might be sufficient to trigger some buys.

CD 12 results were GREAT!

Nice find, BBallCowtown! Shaping up to be an interesting week.

In your opinion Dr Rock, what's the best good news you read in today's PR or heard NP mention on youtube? Did you hear or read anything that really surprised (in a good way)?

Agree 100%, Dr. Rock, there is EVERY REASON to grant EUA now as the new study enrolls, the FDA exists to SAVE LIVES!

FDA is CORRUPT.

Question, daemon57: Since our Friday PR announced - "...hospital stay was reduced by 6 days...with a statistically significant p-value of 0.005" -
can you explain why we need to add 140 patients and do this study AGAIN?

Does 'statistically significant' on Friday not mean 'statistically significant' on Saturday?

And does the FDA have an Inspector General? Not that I would trust a federal bureaucracy's IG office, but for a drug with the best results and no side effects that could have already saved over 100,000 lives - to what the hell is wrong with the FDA?

Correct, Amateur, I agree. But if nothing works better against COVID and drug safety is not a concern and we are competitively priced, I don't see why any nation would not want to buy lots of LL, we should sell boatloads.

One Question: Based on everything we know so far, is there anything in the world that works better against COVID 19 than Leronlimab?

Many Thanks for your reply, Latane!
Nothing to add but strap in and lock your harness.

Good Morning, CTSO! I haven't posted for a while, and though I've reduced my CTSO position, I still follow the board. However, I also follow the progress of another bio, and I would be remiss if I didn't give a heads up.

CYDY will likely announce the results of their Phase 3 study for severe/critical COVID patients next week, and in my opinion, things look good. I've been in CTSO since MSBT - I still have my one and only Berthabluefish1 email in my archive inbox - but I just wanted to give a heads up. All just my opinion, Good Luck and God Bless!

Trying to stay grounded in my expectations, but everything I see and read suggests imminent and outstanding SUCCESS!

2 thoughts about the video:

I find it interesting the interview (via Zoom) seems to have occurred on Monday, 1 March...yet this Portland CBS station only released the video today, 4 March.

I also find it interesting N.P. gave the interview to the TV station during our supposed "quiet" period. And since they played it today, could we possibly infer that the release of results are imminent? Is there a reason the TV station waited 3 days to air it, was that N.P.'s request?

In short, the timing of this has piqued my interest.

On the other hand - is good news ever released on a Friday?

All things considered, I'm guessing GREAT results on Monday, March 8th!

Experienced Bio-Investor Question: Does anyone know how common it is for the FDA to request the "raw data" of a Phase 3 clinical study as soon as it's available?

If it's a fairly common practice, then fine.

If it is not common, why would the FDA do this? Do they have a lot of statisticians on the payroll that break down raw data in parallel with Amarex? Seems like a duplication of effort, so is there another reason for requesting raw data, something the FDA can do but Amarex can't?

CYDY stock watch: It's gotten to the point where - this morning, instead of asking about breakfast, my 13 year old asked me if I got a CYDY PR in my inbox announcing S/C study results.

Have I warped the last of his childhood?
Is he a good fit to be a Black Ops brokerage intern?

"Don't blink, Dad."

Not sure about that BLA filing in the CYDY job ad, it kind of read like something that had been written last year and not updated. Hope I'm wrong.

March will mark my 1 year point for being invested in CYDY, so I'm hoping the anniversary coincides with good news. The science and study results of our molecule have yet to disappoint, so confidence is high!

Great reply, Longtime! Your point of view has a lot of merit, and I have no factual basis to disagree.

All I have is an abundance of hope, a hugely overweight CYDY position...and should we fall short, a recurring nightmare of hearing my wife shriek,

"You did what?!"

Longtimelong, do you mind sharing your reasons or evidence on why you think we missed our primary endpoint?

Happy Pre-Birthday, Niknak1! Hope the 80 candles on your cake will soon equal the number of $ in our share price.

Let's light these candles!

And yet we (taxpayers) just bought 100,000 treatments of a drug with no demonstrated efficacy? Whoo! Sure is easy to spend other people's money!

Maverick, do you know how Eli Lily's monoclonal antibody molecule compares to ours in terms of mild/moderate treatment? Do you know if they had a significant NEWS2 score, and was it as good as ours?

Thanks!

So I put myself in Nader's shoes and, besides the tightness of the fit, I see a huge reason why I wouldn't PR hitting the primary endpoint.

In short, "The FDA asked me to hold off."

Did they really say that? Who knows. But that COULD be a reason they did not PR hitting their primary endpoint. And if you were N.P. and had a drug that had dozens of possible applications - and you were still looking for approval of your first - wouldn't you want to stay in their good grace? Would it make sense to embarrass the FDA, destroy your working relationship with the entity that holds your financial future?

I'm pretty ignorant about medical/FDA stuff, but I assume there's lots of moving parts to this, especially with other nations involved. So if the FDA requests a blackout period so they can line up their ducks, why not?

The entire future of CYDY depends on FDA approval, so let's work with them, not against.

Just saw this on the YMB: "99% chance"

Calstang66 reposted the following from the CYDY/Reddit forum:

"Had a long chat with a college professor who was a former FDA official about Leronlimab. This is not the first time we spoke about Cytodyn, to be clear, he cannot invest in pharma but he provided the following info: If the company is in talks with the FDA, there's a 99 percent chance of approval. Given they have the OLE, that's a telltale sign. Medicare billing codes and EIND are aces in the hole. Chances are the talks are for labeling and that imported drug policies are met. To him it sounds like the FDA is guiding and helping Cytodyn get approved and get it done as quickly as possible. BTW, he reads this board and I asked him to possibly join and chime in, he's going to see if he can do so legally."

3 Questions for MD's and Experienced Bio Investors:

1. In your experience, was yesterday's PR unusual? Does a no-revenue bio company typically announce that "trial data has been unblinded and the results will be reported when the Company has concluded its ongoing discussions with regulators?"

2. Was CYDY legally obligated to tell us the trial results were unblinded? If not, do you think they were trying to communicate something more with the PR, i.e., stay the course and don't blink?

3. If the company publishes no 'bad news' re: the study by Friday, does it really mean our CD 12 results have hit the primary endpoint?

Thanks!

Anyone think the selling is mainly due to impatience? Could be a lot of holders/traders were looking to score some quick $, and when today's PR implied March, well, that's waaaay beyond the trader's event horizon.

Throw in a coordinated short attack and maybe that's why we're down, because - in every educated opinion I've read, CYDY did EXACTLY as the FDA told them to do, no more or less. And when a company has a boatload of future dealings with the FDA, you would be an idiot to not do EXACTLY as instructed.

Wish I had more powder. But like the shot-out Continentals at Breed's Hill, all I can do is watch.

No retreat!

Question, Dr Rock: So, who is this Dr Pestell, and how did he wind up with 17 million shares?

Is he the largest single shareholder in CYDY?

Hope he never becomes disillusioned with the company; the 8 million share dump on 30 June would only have half the impact of a holding like his.

Welcome aboard, Jstamp! I got in CYDY March of 2020, so you have several months of seniority on me. I don't know if next week will be the CD-12 week - I think anytime from now until 15 March is entirely reasonable - but for the sake of those stricken with the CCP virus, the sooner the better.

Good Luck to all Longs!

Great summary on CD-12 timeline expectations by "Hulk" on the Yahoo board:

"Just want to share some industry knowledge regarding timelines after speaking with a trial statistician who leads trial design in multiple pharmaceutical companies.

Basically three milestones after LPLV (last patient last visit). LPLV for CD10 is 14 days after enrollment and CD12 is 28 days after full enrollment.

1. Database Lock - 6 weeks. This involves all the verification that needs to happen for every patient and signed off by all sites. Once data is locked, nobody can change anything related to raw data.

2. Data unblinding - 1 week. This step could be faster if everything goes as planned but typically targeted for a week allow some wiggle room.

3. Top line report - 1 week.

BTW interim analysis typically goes faster as it’s more of identifying a trend and not all data are needed.

So 8 weeks after LPLV should be the typical time to expect top line report. I found this pretty much aligned with CD10 timeline. Enrollment completed 6/11; LPLV 6/25; top line report 8/11, basically 47 days or a little bit less than 7 weeks after LPLV. As much as I dislike Amrex they were ahead of industry standards for CD10.

Mapping it to CD12, 12/15 enrollment completed, LPLV 1/12. Estimated time for database lock 2/23 and top line report after 8 weeks is 3/9. If Amrex performs at same speed as in CD10, we would be looking at the topline report on 3/1.

There are a lot of guess why no news yet, well, my theory is nobody has verified data to do any analysis just yet. Even if FDA requested raw data from Amrex directly, they won’t get it until database lock which I expect to happen some time next week."

I think results will be announced on a Monday, Tuesday, or Wednesday. I know results will be stat sig good, and I also think NP will be so excited he'll want to maximize the splash...and I somehow feel Thursday and Friday are usually reserved for "mixed" or "disappointing" results.

And I bet our SP closes at or above $20 for the day of release!

All in my opinion, which is by no means humble.

Howard, Just read a little on Novavax and their vaccine.

Based on what I read, I wouldn't invest too much into a company that's still months away with Phase 3 results, especially considering the US govt bought enough existing Pfizer and Moderna vaccine for pretty much all the USA. There's still the rest of Earth, but the vaccine field seems crowded.

So given the nearly $300 SP of Novavax - if our severe/critical results show statistical sig - what's your estimate of where CYDY will (or could) be by 1 June 2020? I know you mention market cap as something that precludes an apples-apples comparison with CYDY, but honestly, I don't think too many retail investors consider a company's market cap before they hit "Buy."

Thanks!

CYDY's Law of 3's: As the average share price approaches three figures,
the average long approaches three sheets to the wind.

Titanic Corollary of the Shorts: There's never enough boats.

Another vote for CYDY (and Dr. B.P.). The guy who posted this on reddit is Dr. Pollina, MD, and has known Dr. Patterson since childhood.

-----
Bruce Patterson story
A little context.

Bruce is a long time friend of mine, whom I’ve know Since childhood. I am also a physician. The reason I am invested in CYDY is Bruce. To me this is a BP bet.

True story. When Bruce was 5 his mom was telling people that he would win the Nobel prize someday. It was obviously met with a lot of “ahh that’s cute...and your crazy (under the breath)” by the time Bruce was in college it didn’t seem so crazy. I worked with Bruce for a summer before medical school at Northwestern doing HIV research before medical school. It was my first exposure to what true brilliance looks like.

No doubt Bruce is one of the few true geniuses that I know...and that might not be surprising.

But what is not known widely is Bruce’s character. He is not only brilliant but also a very honest, thoughtful, kind and honorable man. I talked with Bruce this summer (generalities about the virus not leron specific) watched his ted talk from TC andI got to know the underlying science and was sold.

I would never ask Bruce for any inside track informs and frankly he would never me or anyone even a hint. But his excitement for this treatment pathway along with his character is why I am an investor.

Interesting short piece on zerohedge:

https://www.zerohedge.com/markets/so-microcap-biotechs-where-action-next

We're not on the biotech "most-shorted list," but I think that's because our current SP puts us over their "under 2 billion" micro cap limit.

Would obviously be great to release good news into an already-in-progress short squeeze, more blood in the water for ravenous sharks.

Hope your 'good authority' is right, treedonkey. My ammo locker is empty, no dry powder left, so I will wait with my locked and loaded 401k and wait for the PR screaming "Approval is coming, Approval is coming!"

What about the 400k dead? Does any death prove God is not good?

You fly jets, Latane.
Everything else is noise.

3 Market ?'s for B.Ops and other $ Aces:

1. Do you think we'll see a major market contraction in 2021?

2. If so - and assuming CYDY is trading between $10 - $30 at the time (based on good S/C results and/or HIV BLA) - how resilient do you think we'll be?

3. During major market corrections, are there stocks that typically see very little correction, maybe just 10 - 15%? And based on CYDY's potential, could we be one of those that dodge the 50 - 60% slaughter?

Thanks!

Stock price prediction: Up until CYDY, I was invested in just one stock (another biomed company) for the last 10 years. And after 10 years, I only broke even.

Stupid, my fault.

Still stupid, still haven't learned how to diversify, so now I'm all-in on CYDY.

But unless I've brought my previous flat-line performance luck to CYDY, I see $7.00 by Friday on no-news/expectation, and $15 on stat sig S/C mortality results.

That makes a nice scene, Chuckles,

the gall bladder patient telling his anesthesiologist about some amazing molecule while slowly...fading...out...

"Strange," said the nurse. "His last two words were 'monoclonal antibody.'

Hope the surgery went well!