That tidbit has nothing to do with you calling Misiu's son's recovery a placebo effect.

Placebo effect does NOT cure any physiological issues including blood oxygenation due to cytokine storm effects.

You are conflating the subject and introducing unrelated topics.

I'd say truly unbelievable but I'd be lying.

Very believable but so amazing to hear Misiu's son is making such progress and so quickly.

Sounds like you're in contact so please continue to share with her my wishes and prayers for a quick and complete recovery.

This answer defies basic reasoning.

The company blows through millions a month and many voices here profess to count their financial horizon in days or few weeks before bankruptcy arrives. Handing over a few hundred thousand will not change the cash trajectory and therefore CytoDyn has to find a way to raise funds, regardless of whether company officers receive cash or shares, and with the same urgency.

In addition - they have a fixed and very limited number of remaining shares to issue and that they can not just authorize to increase/expand on their own. So - taking from that pool is a greater limiting factor to the company than using up a relatively small amount of cash.

Not worth guessing the reasoning for this but reasonable enough to 'assume' that if they're under investigation (criminal according to some) - the last thing they would do at this point in time is set themselves up for exposure on any metric criminal or otherwise that the SEC or DOJ would scrutinize.

This should be iron-clad straight and narrow regardless if positioning for partnership or just swapping cash for shares.

Nothing is debunked.

Nothing similar about these companies either.

Maybe they shared dates because this investigation was purely about Nikola? Maybe because they were already requested to appear in front of a grand jury within the reporting period covered by the filing?

Regardless - if you have a concern about leaving out details such as dates I suggest you reach out to CytoDyn council or directly to the SEC and find out whether such details are required and why they are not there.

Wouldn't you think dates are privileged as well?

Investigation dates are never to be shared as they may inform potential targets of investigation phases and other metrics and variables that may compromise the methods and outcomes.

All will come at the right time but what we should care about is results and outcomes. Everything else is just noise.

I'm not one for trickle and rather am a subscriber to 'Shock and Awe'.

Will await investigation results, and the fireworks to follow, patiently.

Thanks for all the great work you do!

No. The facts are unknown. That's why an investigation is a confidential activity. No where it speaks about CytoDyn being 'Only'. Only CytoDyn mentioned itself because it is obligated to do so.

Adam F decided to go away for a month. Others may be going quiet in their own way. Who knows what else is going on?

We don't have the facts. We only have one thread of otherwise wide range of activities.

We will become familiar with the facts soon enough.

Now that's the curious fellow (submitter of the FOIA request) that I mentioned in my post :)

There really isn't any reason for a mention of Citron in that letter.

This was an inquiry by someone (who, I believe, was later identified in one of the iHub messages on the board) looking for records about an investigation of CytoDyn.

The response just stated they can not share anything, even if they have it.

The SEC would not mention any other party that it may be investigating as it was not the topic of inquiry, it is counter to keeping the investigation confidential to maximize effectiveness and it would jeopardize the outcomes of such investigation.

We'll all learn the outcomes when, and if, the SEC and DOJ publicize their findings and actions. Until then its a guessing game.

The only companies obligated to inform of involvement in such investigations are publicly traded entities as a part of their communications with investors.

So, if Citron is being investigated - it may not know about it and, if it it aware, it does not have any obligation to mention it.

As a matter of fact, unless a company is obligated to inform its own investors by law, investigative bodies forbid and prohibit any targets of investigation to mention one exists until the case is publicized by the authorities in charge.

The trial's approval and clear boundaries are also available on Facebook, Insta and other official ANVISA social media sites.

This is the url to the Facebook entry, posted on August 4th at 3:08 pm, stating the Leronlimab Severe trial was approved to commence.

https://www.facebook.com/AnvisaOficial/posts/3899476220162036

That is wrong and for all the oppo research you do - stating ANVISA did not approve Leronlimab for use in COVID clinical trials is misleading readers of this board. It can also cause potential family applicants for the trial to second guess themselves and cost them their lives.

The page you sent only references those products that have already been approved or authorized for emergency access. It only references clinical research as an effort without detailing the products under clinical use.

And, by the way, the word NO in Portuguese is spelled NAO.

The word NO in Portuguese actually translates to 'AT THE' in English

This is what ANVISA said about Leronlimab:

Anvisa authorized, on Monday (2/8), the realization of the clinical study to evaluate the safety and efficacy of the drug leronlimab for the treatment of moderately ill patients with pneumonia caused by Covid-19. Leronlimab is a monoclonal antibody that acts as a competitive inhibitor, blocking cell infection.

This is a phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of leronlimab in combination with standard care for patients hospitalized with Covid-19 pneumonia who do not require mechanical ventilation. or extracorporeal membrane oxygenation.

The study is sponsored by CytoDyn Inc., headquartered in the United States and represented by Biomm S.A. in Brazil. The research will be conducted by the Sociedade Beneficente Israelita Hospital Albert Einstein, in São Paulo.

Another clinical study protocol for Leronlimab, referring to patients who, in this case, require mechanical ventilation or extracorporeal membrane oxygenation, is still under analysis of compliance with the requirement.

Want to know Anvisa's news first hand? Follow us on Twitter @anvisa_oficial, Facebook@AnvisaOficial, Instagram @anvisaoficial and YouTube @anvisaoficial

This is what ANVISA said about general medicinal access for COVID.

MEDICINES

So far, there are three drugs with an indication approved by Anvisa for the treatment of Covid-19 in Brazil, one of them – Rendesivir – registered and the other two in emergency use.

AUTHORIZED/APPROVED REGISTRATION:

render

AUTHORIZED EMERGENCY USE:

Association of monoclonal antibodies casirivimab and imdevimab.

Association of banlanivimab and etesevimab antibodies.

AUTHORIZATION REQUESTS FOR EMERGENCY USE:

Tofacitinib

Sotrovimab

Regdanvimab

RESEARCH IN DEVELOPMENT:

Anvisa has authorized more than 100 clinical studies of drugs and vaccines against Covid-19, both new products and products that are already authorized for use against other diseases.

The progress of each research is the responsibility of each sponsoring laboratory.

As these substances are still in the research phase, it is not possible to detail the way in which these products work and use, since their application to confront Covid has not yet been evaluated by the Agency.

As long as the price is right there will be quite a few 'Yea' votes in support of the transaction.

I don't think we're there yet for the entire platform for many obvious reasons, not the least of which is more clinical proof needed to unequivocally showcase outcomes across a broad range of indications that meet statistical significance and are based on a larger test population. Until then there will likely be a significant gap between asking and bidding.

Plus - no idea when the in-earnest conversations with pharma started and how deep they are but it's typically a 6-9 month process and often crossing a year to finalize and publicize.

But I agree this is (with or without the Nader staying/going component) as likely long term scenario - in part or in full scope of the platform's reach.

Wishes and prayers for a complete and quick recovery for your son, Misiu.

Wrong. Not mutually inclusive.

He could reduce his salary and take one or more of any measures as well as complete work in progress. And he could, separately and without association or dependency, protect the shareholders from this fly-by-night poorly-assembled excuse for a business-rescue plan.

I'm not worried about it.

If they PRd they filed a suit and they did not - I'll be happy to perp walk any of them holding the right arm while you hold the left.

Otherwise - title, case # etc. will appear when it does.

His obligation is to protect the shareholders from an assault by a gang of thieves. He's just doing his job in this case.

Soon enough we will find out about the financials won't we? No reason to get tied up in knots.

Might want to call these guys and ask. They would know.

SIDLEY AUSTIN LLP
787 SEVENTH AVENUE
NEW YORK, NY 10019
+1 212 839 5300
+1 212 839 5599 FAX

They may be doing a tuffer one - working on keeping Nader and Kelly out of jail and protected from SEC/DOJ and simultaneously going after the magnificent 13?

That is in addition to the fact that they have proven themselves undeserving to be on the ballot individually or as a group. Incompetence is the least of it, dishonesty registers up there and collusion to achieve self-serving business outcomes is redlining on the gauge.

Sounds like the actions and inactions Nader and team are being blamed for - but at an amplified and more destructive level.

Making changes to improve business prospects should sound reasonable and be desirable for any objective-minded investor. Removing heart and lungs to spite face is the work of the naïve or nefarious elements.

Oh the world seems to have a never-ending supply of these assets. Typically occupy the left side of the normal distribution curve

I have to tell you (and you can believe or not - no proof to offer) - I've been accused of many things, but emotional was never one of them. Maybe a lack of once in a while :)

I agree with some of what you said and realized long ago there are many things the company, the ceo and officers can do better.

But that's also the crucks of what my message was about - while Leronlimab needs to have a trial (or two or three) come together in a fashion that includes proper power, patient distribution, primary/secondary endpoints etc. - there are all the signals in the world to prove desirable bioactivity is taking place as the product interacts with the body.

While my own acid enjoyed digesting parts of my stomach lining over the past couple of years (and no - not all as a fault of Nader) - the learnings achieved from veering off-course to Covid and developing a comprehensive understanding of the association of CCR5 inhibition and autoimmune/infectious disease/cancer mechanisms may have opened a much wider and nearer-term window into a platform play that was nowhere in sight (in terms of practical cellular/biological level interaction understanding) just 18 months ago. Sometime a wayward trip, though unintended and taken by combination of mistakes and circumstances, can end up getting you to a location you never realized you can attain.

And that, in general, means it should never go away, get to zero, or any other nonsense thrown by individuals who's sole objective is to gain from a diminished stock value and use anything from pseudo-science to outright fabricated nonsense and coordinated attacks to achieve that effect.

I'm unable to predict where the value will be a year or two from now but can tell you (educated opinion of course) that in a fire sale it would fetch an order of magnitude above its current market value.

As long as some of the variables align over the next few months no investor should have to worry about a fire sale.

For anyone fogged-up with these decisive and overarching statements about Leronlimab's statistical demise that is arrived at through magical mathematical and research expertise and applied from such a distant lens from the work and patients and yet with the precision of a neurosurgeon - you may want to consider the following to anchor yourself back to reality...

How would a world-class maven ignore:
HIV viral load reduction to below measurable levels, as proven in-vivo in hundreds of patients and for some over multiple years, while considering whether the drug has any biological effect?
The immune system biomarkers modulated and brought under control by the application of Leronlimab - as measured consistently and repeatedly in patients receiving the biologic, while considering whether the drug has any biological effect??
The fact that CCR5 inhibition is cited in hundreds of scientific papers and ACCEPTED globally as a key target for immune disorders, cancer and infectious diseases - WHILE having an approved drug in the class and having unquestionable proof that Leronlimab reaches 100% receptor occupancy in proven and repeatable experiments, while considering whether the drug has any biological effect?
That the FDA is STILL allowing Expanded Access and Open Label access to the drug for COVID as well as Expanded Access for certain cancers, while considering whether the drug has any biological effect?
That hospitals across the US are administering Leronlimab to their patients IN THE PRESENT, while considering whether the drug has any biological effect?
That perhaps hundreds of independent physicians and researchers voiced support for the MOA and drug itself across the US and several countries outside its borders, while considering whether the drug has any biological effect?
That the Philippines medical community and government administered this drug to its ex-president and then expanded access to the drug within its hospital systems, while considering whether the drug has any biological effect?
That patients are receiving the drug in a cancer basket trial IN THE PRESENT, while considering whether the drug has any biological effect?
There are so many more...

Ask yourself - Would a World-Class Maven:
Ignore the probability that the likelihood of all the above occuring by chance (as in not meeting the statistical significance p-value threshold of 0.05) is as close to zero as anything can ever get?
Believe the entire network of institutions, scientists, physicians, business associates, governments and other players is being hoodwinked and missing the obvious 'correct' answer that is only visible to said skilled maven?
Miss assessing the relevance between clinical significance, biomarker-level proof of effect and cross-correlative outcomes relevance between various treated conditions and instead revert to a p-value of an underpowered trial as the only indicator of efficacy?
Who's never touched a patient or seen one recover from COVID after failing multiple treatments and being at death's door have more credibility than said patient or their doctor?

Should a world-class maven with an interest in gaining from a stock's devaluation through shorting ever be considered an objectively reliable, balanced and honest source of investment input on said stock???

The answers to the above should be fairly obvious and dealt-with accordingly. If it doesn't pass the smell test then consider it a feeble attempt at entertainment and devote your attention to sources of information, pro and con CytoDyn, that can pass the real-world logic-test any infant (or first year college student) can apply when assessing options and actions.

Here's some potential events with outcomes that carry a reasonably high probability:
Results from a appropriately powered and successful trials will shift the stock's value to a completely different baseline
Upon that outcome - most of the gifted and helpful crowd will disappear into the quantum cracks of the internet faster than a photon in space
After reaching a new and higher trading baseline - a new, more capable and sophisticated gifted and helpful crowd, will appear to 'help' investors in supporting their journey to the next level

Thanks and yes - definitely do not panic. So long as US OLE and Expanded Access is around and Brazil trials just got final approval - we have enough evidence that signal is strong and we need to see it through.

If the SEC/DOJ investigation was about whether the drug works or not we should have seen patient access restrictions by now and Brazil should not have approved commencement of trials.

It's going to get dirtier but this is where the intersection with fun resides anyway.

Classy, Relevant and Accurate as always.

Great perspective Misiu and the credence that this 13D adventure is more about revenge, self enrichment and control, and less about any shareholder benefit, is cementing by the day.

Yes - been around and have some scars to show for it :)

We may have many things we agree on regarding Nader's means, methods and ways but also disagree on some of the cause/effect of the most significant issues we have witnessed such as the BLA botch. This is not taking any accountability and responsibility from Nader but keep in mind that the FDA is not accountable to anyone (despite what you may hear about checks and balances) and gets away with ambiguity, re-direction, stall/delay and 'just one more thing - Columbo style' means to throw anything off course. I'm not insinuating its always nefarious but am stating that these things cause havoc in the timeline and stability of a filing plan.

Lastly - I think the conundrum about needing a strong and bio-fit CEO is a key element that needs examining. Wishing upon a CEO the likes of those that run any of the big pharmas (JnJ, Glaxo, Pfizer, Merck, etc.) is unrealistic as those CEOs are rarely the ones that take a company from pre-revenue to a megaorg. In addition - I would position that many of those CEOs would not know how to street fight for survival of a pre-revenue biotech as they are skilled and trained to wage strategy and wars with very large treasure chest and apply that as one of their tools. Our CEO can do much better in some aspects but I would always be in the gray on this one and that is where we may differ.

Having seen and researched the 13D slate I can tell you unequivocally, from my standpoint, there is not a single person in that group that can do a better job. And more so, they are banded together with (what seems to be the main driving force) hatred for Nader and do not coalesce around anything positive in terms of synergistic benefits or value of combined skills. That kind of binding force can bring nothing but destruction to CytoDyn as if they ever gained power (and my bet is they will not) - they would turn in on themselves in a race towards liquidation and conversion to cash. It's like season 5 of the Money Heist ;)

I sure hope (and expect) that these answers are fully vetted as it was described.

And agree that shareholders should be careful both on behalf of themselves as well as for the company's benefit - although once the company (Nader or otherwise) puts out a statement in email or otherwise it is truly on them to make sure nothing improper was shared. Once out in public domain all bets for confidentiality are off.

I missed one or two over the past three years.

At times I was willing to administer Singapore-style caning justice with my own hands. SMH many times.

That said these things are not mutually exclusive.

One can appreciate some things about him, and depreciate (despise, not like, get mildly irritated, etc.) many others.

It is not as simple a black and white choice as many espouse it to be. Being deep from within pharma and for a quite a long duration - numerous items many (dis)credit him for are complex and not a situation created/solved/destroyed by one person. He has many culpabilities but if I told you what happens in the hallways of big pharma in terms of massive screwups that never get shared with the public (one of Nader's deficits - not knowing when to stop sharing his thoughts or aspirations) you would not believe it. Companies with 10s of thousands of employees and dozens to hundreds of BLAs or sBLAs, NDAs etc. botched trials and more.

But I'm not here to defend him but rather to pose a real-life scenario where everyone engaged is operating in very dynamic and error prone environments (FDA conduct over the past 18 months is one example) that we should not fantasize even for a moment that Nader is the source of all trouble and, even worse, the 13D are the source of any comfort or salvation.

If 13D truly were interested in helping shape up the ship - they would offer a reasonable approach such as two directors or expanding BOD and placing 50% voting rights/seats with 13D directors. That, together with a coherent plan that does not portray CytoDyn to be the biggest disaster the world of biotech has ever seen would lend them credibility and support from many folks (like me with a very sizeable share count) who would be willing to force some additional accountability while sustaining respectful dialog and employing collaborative methods to address gaps while still moving forward.

A company the size of CytoDyn with 20 +- staff could be set back two years with this type of hostility. Is no one considering the effect of what comes across as all out war on the entire company? That with BOD, Nader, Kelly and one or two others, several of the few remaining leaders would run out and want nothing to do with the crowd that came to gut them? No one can just come in and resurrect a biotech after losing 30-50% of its brain trust. Not to mention any collaborative and supporting relationships from hospitals, research institutions and others.

They are not coming to help. And if they think they are - they are not qualified to help as they have absolutely no understanding how crippling such as 'swap' can be.

But I agree with you. Nader has some things to work on!

The lens you're applying is incorrect.

The SEC or DOJ do not typically inform the persons under subpoena who else is being investigated, how its proceeding, what is next, when is it over etc.

Whether a company initiates the complaint (requests someone look at something), is involved in an investigation that initiates by someone else's request or is the direct subject of the investigation - they are not privy to anything other than what the investigators ask of them during various written and oral interview sessions.

Second - they are under strict orders to divulge nothing other than what is absolutely required by law for shareholder notification and information sharing. Nothing else can be divulged as it would place the investigation at risk of being compromised and inform potential suspects or others of events - providing lead time to escape/prepare or market manipulate.

In my very basic involvement through the SEC interview I mentioned as a shareholder of a company under investigation - I was warned very sternly on a recorded call with multiple investigators. When the charges were brought forward and docket/supporting evidence was shared - the government had included hundreds of references to traced calls, texts, digital actions, timing and cascade/sequence events that showed collusion and more - with dates that were months before and months after my interview. To be clear - these were not related to me in any way - but to people involved in the criminal activities and those who were dumb enough to chatter even when warned not to. They have access to emails accounts, mobile and land line and a thousand other ways to trace whether anyone (such as one like me - interviewed regarding the company) contacted anyone they are not supposed to or said/shared anything they are not supposed to share.

Nader and CytoDyn can say NOTHING (whether they are being looked at as the culprit, victim or anything in between).

Don't read too much into this. It will become visible when they are ready to make it so.

Will you still be humble when it does not halt tomorrow or ever?

I'm sure someone will theswordman.

Life is a perpetual opportunity to be good, bad or indifferent (and many of us play multiple roles along the way)... That said - darkness vacated by a dead-ended thug will be promptly filled in OTC as well as elsewhere. Seems humans have an insatiable appetite for criminal behavior and carry it out in ways that very much perplex outside viewers (as in - and you thought you'd get away with that??)

Thinking Madoff and Skilling (mega size crimes) all the way down to idiots stealing from cash registers during their work shift.

Very long way of saying that while I agree with you that OTC is a cesspool (my words) that attracts the worst types, and I would love for us to graduate to hang with a better pack of friends, NASDQ NYSE AMEX and other have equally misguided and often more sophisticated ringmasters.

Someone's got to keep law enforcement of various types busy ;)

Thanks tradero and very much likewise!

moneycrew - I don't use twitter and only spent a few minutes searching but the only reference to vacation (and no other to personal sabbatical that I can find) AF ever made was two years ago and for the standard two weeks off.

Maybe there are other occurrences folks are aware of but if not... a month off for someone who's role in life (as miserable and pathetic it is) hinges on projecting relevance by bombarding the ether with frequent and constant self-serving tweets and bottom of the barrel biotech analysis articles just does not sound kosher.

I've also read other notes from sages on this board that SEC and DOJ always investigate for a year + before taking action or making their action known. That's a heap of nonsense as the first order of priority for SEC and DOJ is to protect current and future investors and an immediate shut down or restriction in trading.

In the one case where I was directly affected (as an investor in a company that ultimately saw its leadership get charged and jailed) the SEC suspended trading (OTC BB stock) out of the blue, conducted an investigation for nearly 9 months (I was approached and chose to provide statements as an investor) and upon conclusion of the investigation charges were filed and the suspension became permanent.

I am personally very excited to see these investigations take place as its a win all around. If CytoDyn's leadership is actually guilty of any wrong doing - I will welcome any provable and reliable finding and associated actions. If this relates (as I suspect) to the criminal behavior that resulted in a totally unnatural trading profile over the past 12-15 months - watching anyone take a well-deserved beating over these activities and decoupling CytoDyn from the effects of the criminal cabal would be most satisfying.

Looking forward to these events unfolding!

theswordman - you don't disagree. You don't understand or perhaps are not aware of the circumstances around ECOR and why it was and is an absolute horror show of an investment. This factually sits on Errico and the rest of the founding and leadership team.

Financials:
Company way way overpriced with last two rounds of investment converting at around $10+ per share
IPO price offered to the investors at around $15 per share
The stock spent about a few hours above the offering price and immediately started to sink
All early (pre IPO investors were locked/restricted in share transaction activity for about 1 year (could be off but not by much)
At the time restriction was lifted the shares were worth less than 20% of the original investment

Here's the kicker - when selling the investment opportunity to investors, the sales projections were listed as $42MM for 2018, $142MM for 2019 and $280MM for 2020. You can do your own research but I can tell you that they are just getting to $12MM +/- in sales for 2021.... Yes - it was supposed to be $280MM last year and the numbers are just creeping past $12M. Brilliant.

So yes - nothing about this investment or the people associated with it is anything to highlight as a success or a target of association. At ANY level and any aspect of the business throughout its lifecycle to the present.

MOA and Therapeutic Modality
One more very important note.
To compare the development, testing and regulatory approval of a non invasive medical device designed to address pain management (no disrespect to pain or migraines which are devastating to have) to the process of developing testing and approving a biologic that targets viral entry and immune response/modulation on the cutting edge of science and current knowledge is absurd and a non starter.
The ECOR device, though innovative, is an external version of an implantable product whereby the science behind contact based vagus nerve stimulation was well understood over a very long period. While developing an innovative way to transmit elect stimulation impulses through the skin required some creativity and engineering prowess, it is just that and incomparable to the work going on to develop CCR5 based therapeutics.

There's so much more to say about the subject as well as the magnificent 13 but that is not the topic. Let's just not confuse ElectroCore with anything positive and at any level.

100% FDA - 100% correct!

And to change the dosage mid-trial there has to be a strong signal that the design dosage is not working at all, which was not the case as we learned.

Much further down the trial timeline, and with a larger patient population which also included a more diverse set of health conditions and outcomes, the evidence became clearer regarding the difference dose 3 & 4 make.

- FDA disallowed it at first
- It severely impacted trial outcomes (and more importantly patient lives)
- FDA washes hands and no one can be held accountable (or will come forward and BE accountable)

We move on to other designs while whistling a tune as if nothing happened.

MH

hotmeat - your statements regarding the roles of DMC /DSMB are inaccurate and incorrect.

For factual information about the role the committee and the FDA - please read the following: Guidance for Clinical Trial Sponsors

I'm sure there are plenty of people on this board with actual experience on the subject matter who can shed light on anything that may be difficult to understand or is ripe for a lively discussion or perspective.

As an overview...

No - the DSMB:
Does not decide anything. They monitor and recommend.

Yes - the FDA is highly involved in trial design and review of DSMB updates and recommendations

Yes - only the FDA or the sponsor can stop a trial based on findings or recommendations

One little tidbit from the document - but there are 38 pages well worth reading;

"7.3. DMC Recommendations for Protocol Changes
A DMC may, in some instances, recommend changes to the study protocol, particularly
in the context of their responsibilities for monitoring patient safety. Many protocol
changes have little impact on the usefulness of a trial to gain regulatory approval. Certain
types of changes to the protocol, however, such as changes in the primary endpoints,
could have substantial impact on the validity of the trial and/or its ability to support the
desired regulatory decision if they potentially could have been motivated by the interim
data. We recommend that sponsors discuss proposed changes of the latter type with FDA
before implementation."

Because the FDA's guidelines and documentation are as fluid and interpretive as they come, it allows the FDA to approve a trial based on an initial design, and change goal posts afterwards based on an infinite number of possible scenarios. This happens time and time again and is an iterative dance performed over history and shall forever repeat itself so long as drug development remains the difficult, always evolving and non-exact science that it is.

MH

Thank you for sharing these exciting updates in real-time Misiu. Agree on the likelihood of imminence of EUA. Once awareness of the drug and its effect in the public domain there will be no way to stop it.

How does one explain giving it to an ex president, saving him, expanding access, presumably helping others, then not making it an official EUA?

MH

Actually - cheering a drug that has shown better results in addressing severe and critical disease than anything tested by any pharma, large or small, to date.

Very exciting stuff!

All signs point to this train having left the station.

MH

SansBS - for clarity, I was being facetious and indirectly conveying my appreciation for individuals like Rockleo, Misiu, CTM, Latene and others in the medical field who are painted as ineffective (together with all MDs I suppose) in bringing a science mindset and knowhow into drug development and use discussion...

Total BS narrative and I'll leave it at that.

That being said, I'm also a big fan of Dr. BP and would love to have him more deeply integrated with the CytoDyn team as they navigate this journey. None of us know what exactly happened there and I'm not going to guess but just hope the right people of all disciplines join and continue to orbit around and support CytoDyn's journey to commercialization and beyond.

MH

Fully agree with your assertion. The invisible but always present forces and face-saving actions (or inactions) to avoid egg-on-face for the US can and does carry a lot of weight in the conduct and actions taken by those depending on its support.

I just hope this specific Covid pandemic scenario is just sufficiently different to break through these unspoken agreements. With enough pain on the ground and carnage in hospitals, and pressure on local governments from their constituents, and possibly an inkling of a real journalist or two, of there are any left, willing to bring fact to light, there may be just enough pressure to break the habit.

But one can only hope.

MH

dad [if I may call you that ;) ] reasonable assertions but there's a bit more color to pre-revenue biotech than many traditional investment types that always makes it more exciting or terrifying - depending on which end of the muzzle one is positioned at the time of the end game.

I think of it as a loaded spring that can either bust through the top (fly up) or crack through the floor (violent fall) holding itself in a balanced position, while still volatile, until equilibrium is heavily shifted in a permanent way.

While many PRs will result in some oscillation and eventual equilibrium (new or old position), one that signals a major shift in direction (even if it doesn't hit the coveted milestone yet) can violently change the base and quickly.

Example - if one Asian country (PH as example) officially grants EUA, the move is likely to be nonlinear and asymmetric relative to the immediate quantified results. Meaning - a signal of market acceptance by a foreign government and a modest amount of revenue can push a company's stock in this position way beyond an immediate representation of the value of the sales.

In the case of CytoDyn, and if that should happen, it would eliminate many psychological barriers that investors develop by internalizing messaging and claims by individuals who are negatively biased against the company.

So, if such milestone is reached, some real or perceived concerns are immediately vaporized and are no longer a consideration on the risk column for anyone performing a risk analysis on their investment.

So, just an example, should PH or another country grant EUA, what does it mean?

- Drug doesn't work? False - notion eliminated by association of approval with awareness of efficacy/value

- No one will ever use it unless the US FDA approves first? False - notion eliminated by having any first country grant EUA without dependency on the US

- Market is small and of negligible revenue? False as a first EUA will very likely result in a cascade of likewise decisions from other countries. Many Asian countries and especially in SE Asia work and unison and coordinate their activities, intentions, data sharing and more. It is entirely conceivable that with one EUA granted several more will opt in within days or weeks. Nothing is a given, but it is a realistic scenario especially given the limited supply and significant need for anything that works.

- This is a blip and will go away? HA (or AH AH AH). Nothing is going away anytime soon and if this drug works as many of us investors (and esteemed non-scientist doctors) believe, applying it to a greater population will just prove its worth faster and generate intense demand. My expectation, if it performs as it did in trials and eIND/OLE to date, is the effect will be immediate on hospital bed utilization, load and capacity. Within two to three weeks of broad use within any hospital one should see an immediate drop in mortality and bed utilization relative to previous weeks. It's that simple - no noticeable drop - it's not working. Noticeable drop - ultimate proof and demand will be asymptotic.

Many more elements that will fall off the 'concern' list can be added but we can stop here. The point being that a PR with a seemingly small step can have a profound effect while a combination of many others may not.

Here's to getting that low-intensity high-implications PR with urgency!

MH