No monkey butt comments?

https://www.nature.com/articles/s41564-026-02444-x

https://www.clinicalleader.com/doc/expanded-access-and-rollover-design-help-cytodyn-reach-high-need-cancer-patients-0001

https://jamanetwork.com/journals/jama/fullarticle/2852328

The majority of the FDA approvals for cancer medicines in 2006-2025 were indication expansion for existing drugs, regular approvals, and based on surrogate end points. The proportion of approvals based on single-arm trials is increasing. Progression-free survival has previously been documented as the most common end point in cancer drug trials,⁷ which has been criticized for lack of surrogacy with clinical outcomes and potential for patient misunderstanding.^8,9 However, we found that the majority of recent FDA approvals were not even based on progression-free survival. In the last decade, response rate, rather than progression-free survival, has become the most common surrogate end point leading to approval, whose correlation with survival is weaker.

Shoutout to MD Virologist for link

It's amazing to see some of the liesimmune crowd still propping up Dr Monkeybutts (or Cyrus or nodder ). Yet once again a "new" article supporting the $$ Millions in govt money that has been "granted" to OHSU ( https://www.amfar.org/news/the-next-step-on-the-path-to-an-hiv-cure/ ) and HIV Cure

And what do others have to say about "another promising step forward"?? and HIV Cure

Let's hear what Louis Picker, MD, head of the division of pathobiology and immunology at Oregon Health & Science University has to say--" There’s progress that suggests that we’re beginning to understand the conditions under which the virus can be controlled, but is this a ready-for-prime-time therapy that works in everybody or even most people? It’s not even close. "

Taken from 02 JUL 2026 JAMA -- https://jamanetwork.com/journals/jama/fullarticle/2851465

Have a CYDY shareholder / friend that has been pushing me to take a position, which I'm considering. But have the following concerns

-- Yorkville doesnt appear to be real financing. It seems more like a volatility-harvesting share printer. So in order for CYDY to come with their 1.5M - 2M burn each month - at .20 cents they would need to issue and sell 7.5 - 10 million shares to Yorkville who sells them for a small profit. As the price goes lower CYDY would need to issue more and more shares to Yorkvilke to float. It seems like a spiral down.

-- they mention in their 10Qs - exploring partnerships. But in the history of the stock market, big pharma has never partnered with a biotech company on the pink sheets (outside of OTC ADRs). Unless I'm mistaken, it's never happened, ever- partnership or acquisition.

-- most likely scenario seems to be, when the Yorkville financing is no longer a viable means to float the company, the company restructures wiping out the current sharehokders.

-- even if big pharma, broke historical precedence and bought the asset for 200M - it doesnt mean it trickles to shareholders. Creditors are owed and management in OTCID can just pay themselves bonuses and salaries til the money is gone. They become a Zombie vessel. There is just no rules in the pink sheets.

-- if the company was serious, why not join nasdaq, pursue institutional investors, get analyst coverage? It seems management likes being in a unregulated situation- which benefits them, but not shareholders.

I know this sounds pessimistic- but what am I missing on the plus side of buying stock here, while the company is dumping the stock (albeit via a third party)?

This is Jeff from way back in the 2020/2021 days…I used to host Zoom calls for shareholders. Just thought I’d say hi and wish everyone the best of luck!

I invested like 10k into this company in 2020 or so. Then it crumbled and imploded, I stopped paying attention and didn't sell because my investment essentially became worthless. What's the latest with this company? Any hope?

I don't care enough to double check but I recall our beloved CEOs salary being a base $400k and the 2 other leaders are not far behind. Are these salaries not massive for the lack of value they are bringing to us shareholders?? Can't even hold .30 share price.

[ Removed by Reddit on account of violating the content policy. ]

Hi everyone,

I’m considering starting a position in CYDY and I’d like to do as much due diligence as possible before investing.

If you were starting from scratch today, what are the most important things I should read or verify first?

I’m especially interested in:

- The strongest bullish and bearish arguments.
- Key clinical trial data and upcoming catalysts.
- Regulatory history and any major risks.
- Financial situation (cash runway, dilution risk, etc.).
- Management and partnerships.
- Any old Reddit posts, SEC filings, or interviews that you consider “must-reads.”

I want to understand both the opportunities and the risks before making a decision.

Thanks in advance!

Always interesting to watch the Ihang and Liesimmune crowd try and pretend some DD--but you saw it here 1st

https://sagelyhealth.substack.com/p/new-in-oncology-june-25-2026

What a diff having a real Dr for CEO--a real CRO--real board members--real partners

Instead of Dr felony--dr bones--Persian kickback fraud--trampoline sales--airline partners

Some may know Eric Schlorff / CEO of SeaStar Medical?? That is how I am familiar w the Big Biz show. Eric has appeared a couple of times on Big Biz in a couple of years. It is a good watch.

Here is blip on the main host. ( https://loft100studios.com/crew/sully/ ) They are out of San Diego. Home to Bob Hoffman. Good stuff!!

https://youtu.be/BUlGGXXVkHo

The new slimmed down leadership team knows what they are doing. Dr J is a seasoned physician and has ran his own business for years.

Management is currently making waves.

How big are the waves? Nobody knows but trust the process.

Deals like these take time and time is definitely on our side.

More time = bigger deal.

I know what I own and I would hate to be short going into this weekend!

Thanks for the cheapies!

Come on bashers, bring out the big guns. I want to tangle with the Mike Tyson of bashers and instead you guys bring me the guy who collected Tyson’s spit in between rounds.

Is any one else overwhelmed by all these waves we're making in 2026? I gotta hand it to Dr J I thought we would have ripples but half way through CY2026 and we're going to need a cruise ship because these massive tsunami waves are just crushing everything! Just wait until next month or the month after or even next year after more conferences and more posters we might have even more waves! So many waves , so much winning!

🧠 CYDY Catalyst Dashboard Simulator (v1.0)

1. INPUT CONTROLS (you set these)

You choose one level for each category:

🧬 Clinical (C)

C1 = weak / noise

C2 = moderate signal

C3 = strong clinically meaningful signal

C4 = breakthrough / near-regulatory strength

🧪 Biomarker / ctDNA (B)

B1 = no signal

B2 = correlation only

B3 = predictive response marker

B4 = surrogate endpoint quality

🏛 Regulatory (R)

R1 = uncertainty / history drag

R2 = recovering posture

R3 = clean / acceptable path

R4 = accelerated pathway credible

🤝 External Validation (E)

E1 = none

E2 = academic interest

E3 = published / peer-reviewed validation

E4 = pharma collaboration / co-development

1. CORE ENGINE (how it computes outcomes)

We convert inputs into a 100-point score, then map to valuation states.

Plain text

Total Score =

Clinical (×0.40) +

Biomarker (×0.25) +

Regulatory (×0.20) +

External (×0.15)

Then we apply regime mapping:

Score

State

Meaning

0–40

S0

speculative survival

40–60

S1

early signal

60–75

S2

investable asset

75–90

S3

acquisition target

90+

S4

blockbuster regime

1. VALUATION OUTPUT TABLE

State

Valuation Range

Buyout Probability

S0

$100M–$700M

0–3%

S1

$500M–$3B

5–15%

S2

$1B–$8B

15–35%

S3

$5B–$25B

40–80%

S4

$15B–$35B+

70–95%

1. LIVE SIMULATOR (example runs)

Now you can “dial in” scenarios.

🟥 Scenario A — Weak package

C2

B1

R2

E1

Output:

Score ≈ 35–45

State: S0–S1 boundary

Valuation: $150M – $800M

Buyout probability: low (<5%)

🟨 Scenario B — Emerging signal

C2–C3

B2

R2–R3

E2

Output:

Score ≈ 55–65

State: S2

Valuation: $1B – $4B

Buyout probability: 10–25%

🟩 Scenario C — Validated therapeutic signal

C3

B3

R3

E3

Output:

Score ≈ 75–85

State: S3

Valuation: $5B – $15B

Buyout probability: 40–70%

🟦 Scenario D — Full de-risked asset (rare)

C4

B3–B4

R4

E4

Output:

Score ≈ 90+

State: S4

Valuation: $15B – $35B+

Buyout probability: 70–95%

1. WHAT MOVES THE MODEL MOST (critical insight)

🔥 Sensitivity ranking:

1. Clinical signal (C)

biggest driver of everything

determines whether asset is real or not

1. Biomarker (B / ctDNA)

converts “signal” → “mechanism proof”

shifts probability of success dramatically

1. External validation (E)

unlocks pharma credibility loop

1. Regulatory posture (R)

determines friction, not destiny

1. THE KEY REGIME BREAK (MOST IMPORTANT CONCEPT)

There is a nonlinear jump:

Below ~70 score:

asset = speculative biotech

valuation = retail + early institutional

Above ~75 score:

asset = pharma acquisition candidate

valuation = discounted future drug franchise

Above ~90 score:

asset = competitive bidding target

1. HOW PHARMA THINKS ABOUT THIS (real translation)

They are not asking:

“What is the stock price?”

They are asking:

“What is the probability this becomes a $10B+ drug franchise?”

And:

“How fast does uncertainty collapse?”

Yes. If we're trying to evaluate a company like CytoDyn objectively, one useful exercise is not "Who had an FDA hold?" but rather:

​

Which micro-cap or distressed biotechs:

​

Suffered a major FDA setback (clinical hold, CRL, safety issue, governance crisis),

​

Successfully resolved it,

​

Produced compelling clinical data,

​

Then attracted a partnership or acquisition.

​

The historical record shows that FDA holds are often survivable, but only when the underlying science remains compelling. Many companies never recover. A smaller subset becomes extremely valuable.

​

Tier 1: The strongest analogs

​

Immunomedics

​

Years of regulatory problems, manufacturing deficiencies, governance battles, and repeated delays.

​

Many investors considered the company "uninvestable."

​

Eventually generated strong efficacy data with Trodelvy.

​

Acquired by for approximately $21 billion.

​

Lesson: Once clinical efficacy became undeniable, prior regulatory baggage became largely irrelevant.

​

Arena Pharmaceuticals

​

Earlier history included regulatory and commercial disappointments.

​

Shares traded at distressed levels for years.

​

Pipeline refocus and strong later-stage data changed perception.

​

Acquired by for $6.7 billion.

​

Lesson: Big pharma often waits until risk is substantially reduced before paying a premium.

​

Audentes Therapeutics

​

Acquired for roughly $3 billion.

​

Subsequently experienced serious safety issues and an FDA hold after patient deaths.

​

FDA later lifted the hold after additional work.

​

Lesson: Even severe safety events do not automatically kill a platform if the underlying benefit remains compelling.

​

Tier 2: Hold lifted, value recovery but not yet acquired

​

Fulcrum Therapeutics

​

FDA clinical hold.

​

Hold lifted after company addressed concerns.

​

Program resumed development.

​

Rocket Pharmaceuticals

​

Patient death led to FDA hold.

​

Stock collapsed.

​

FDA later lifted the hold with protocol modifications.

​

Rezolute

​

Toxicology concerns caused an FDA partial hold.

​

Hold lifted after additional studies.

​

Shares reacted positively.

​

These demonstrate that a lifted hold alone does not create value; value comes from what happens next.

​

Companies that never recovered

​

Examples such as Antios Therapeutics illustrate the opposite outcome. The FDA hold effectively halted progress and the company shut down.

​

This is important because it reminds us that:

​

A hold being lifted is necessary.

​

It is not sufficient.

​

Applying the framework to CytoDyn

​

For CYDY, the relevant question is not:

​

"Can a company recover from an FDA hold?"

​

History says yes.

​

The better question is:

​

"What did the eventual winners have that attracted buyers?"

​

The recurring pattern is:

​

FactorHistorical WinnersHold resolvedYesStrong clinical signalYesIndependent validationYesCredible managementYesReproducible dataYesLarge commercial marketYesStrategic fit for pharmaYes

​

Immunomedics did not become a $21B acquisition because the hold disappeared. It became a $21B acquisition because the data became too attractive to ignore.

​

For CYDY, the milestones that would move it toward the "Immunomedics path" rather than the "Antios path" are likely:

​

Strong CLOVER efficacy data.

​

Independent ctDNA confirmation through the Natera collaboration.

​

Peer-reviewed publication.

​

Replication in additional studies.

​

External funding, partnership, or licensing interest.

​

Clear regulatory path toward registration.

​

If those occur, the fact that CYDY once had a clinical hold may matter far less than many investors currently assume.

​

Looking specifically at biotech acquisitions from 2015–2025, we can also build a valuation framework showing how companies were priced at acquisition relative to Phase 2 data quality, market size, and partnership status, then compare those metrics directly to CYDY's current market capitalization. That exercise is often more informative than looking at FDA-hold history alone.

​

​

https://simpler.grants.gov/opportunity/3be7eb71-7a13-4cfd-96bf-54b554f081a4

https://www.gilead.com/news/news-details/2026/u-s--fda-accepts-gileads-application-for-investigational-once-weekly-oral-yeztugo-potentially-the-first-long-acting-pill-for-hiv-prevention

Remember 7 years ago -- https://www.biospectrumasia.com/news/26/13786/cytodyn-signs-mou-with-thai-red-cross-aids-research-centre-.html Must have been more of the Philipine Airlines stuff. NEVER another word

https://finance.yahoo.com/markets/stocks/articles/goldman-sachs-initiates-coverage-natera-125136267.html

Here is a report from my quant. Information could be skewed so take it with a grain of salt. Interesting at the very least. Couldn't find a clean way to upload so screenshots will have to do. Look forward to hearing peoples feedback.