“Secured” has a legal definition. Ask Elon Musk.

Legal told him to STFU.

Ohm20, please...

We were NEVER at war with Eurasia!

I'll do this once more, then you can have whatever last word you like. Just don't use the word "attitude" - it's more like contempt. Words have meaning, and I like to be precise with them.

That's an interesting take. I'm assuming that you also assign a zero value to leronlimab - and all other clinical-stage drugs - since they're not currently a salable product with FDA approval? Someone really should alert the entire pharmaceutical market of this new truth. Isn't this the entire purpose of discounted cash flow analysis? You know... the bread and butter work of an analyst? If you're assigning zero value based on lack of progress, that's just silly. I haven't seen any progress on the BLA since they filed the pre-clinical portion a little bit back, better assign zero value for lack of progress, right? You don't even know the device pathway well enough to know the proper name of the pre-market filing without looking it up. Once more, just incredibly disingenuous.



I'm left to assume that proper usage of inferential statistics isn't your thing. Let's assume that your statement that most companies with medical test devices aren't doing well is correct prima facie. The problem with then assigning zero value to an individual medical device based on this information is that you happen to have additional, differentiating (for better or worse) information on this particular device, thus you can do better analysis than simply ascribing the characteristics of the population. Here's an example. I find 80% of posts on this board useless. If I were to pick a random post, it would then have a 20% chance of being useful. However, if I knew that I was picking one of your posts, it would have a 0% chance of being useful. You don't get the 20% assumption from the population, because I know more about the post - I know that it's from you. See how that works? Inferential statistics are only useful when assigning probabilities to a random observation from a previously described population.

TL:DR - It's a meaningless argument here that most medical devices that are tests of some sort aren't doing well. Sloppy on your part, again. At best.



Name one clinical stage device/test - or drug, for that matter - that has insurance reimbursement. Again, just an absolutely meaningless argument. Sloppy at best, intentionally intellectually dishonest and disingenuous at worst.

Finally, better attempt at a red herring here, but still off the mark:



That's fantastic, but the conversation in question from February was simply asking "how much would it cost to build a sales team and go it alone?" Your response was "company XYZ needed $50-150mm to build a sales team and continue developing its pipeline." The fact that you didn't see the need to differentiate between whether it took $50mm or $150mm - or somewhere in between - and how much of that money was needed for pipeline development - did they only need $10mm to build a sales team and the rest was for pipeline development? - tells me that you never had any intention of engaging the conversation honestly.


I'll give you one thing, you have thick skin. I can't imagine how much it hurts to repeatedly bang your head against a wall like this. See you in a month or so when I feel like taking time out of my day to call you out again.

I’m glad you enjoyed my joke. I thought it was pretty funny.

It’s less funny that you shamelessly prove my point and yet still soldier on. You were too lazy to look up what the filing is called? So let me get this straight: you’re so ignorant of medical devices and the markets/processes involved with them that you would have had to look up the process to get the name of the pre-marketing notice required by the company, yet you somehow know it all well enough to brazenly proclaim that there is no value at this time, and that we can assume there’s still time and money attached to the runway for achieving value? You must be superhuman, because the cognitive dissonance there makes my head want to explode. The amazing thing is that you say it all without batting an eye. What would you think of an “analyst” who had to look up a BLA to get the name right, and then assumed that there was no value in a drug because the BLA wasn’t filed yet? It’s complete nonsense dressed up as lazy analysis.

Here’s an idea. If you want to be taken seriously, do some actual analysis. Understand the 510(k) process, research the market potential of the prognostic test, learn about recent comps, find a PV, and discount accordingly like you would any other asset with future cash flows attached.

I’d say that I’ll wait... but I won’t. Last time I asked you for an example or better analysis of something (February 2019, discussing the potential cost of going it alone), the most you would offer is an anecdote about a company that used “between $50-150mm to build a sales team and continue developing its pipeline.” As if that definitively settled the matter. I expect no better from you this time. You clearly have an agenda - again, I’ll say that it must be nice to live in a jurisdiction with no capital gains tax. You get yourself in trouble when you get sloppy picking your spots in which to be disingenuous. That shouldn’t surprise anyone though... it’s not like a reputable equity shop is letting its analysts run a side hustle on blogspot to pimp OTC stocks. I tired of this board long ago, mostly due to your nonsense, so I probably won’t be back for a while to continue this conversation. I’ll just drop by now and then to remind anyone who happens to not be paying attention that you’re full of it and should be disregarded.

By the way, excellent red herring re: enrollment. It sounded good on paper, but I thought about it on my entire six hour bike ride today and still can’t come up with a single way that it applies to your (at best) blatant and willful ignorance of the medical device market.

Not that I need another reason to disregard your posts, but until you know that the filing for a medical device is called a 510(k), I’ll have to take your thoughts on the timing of the value of medical devices with something more than a grain of salt. And before you defend it as a typo, you clearly knew that you didn’t know what it was since you put (sic?) after it in your post. Anyone can be an analyst these days, huh?

Hopefully they get that BAL filed on time for leronlimab.

Appreciate the Cliff’s Notes.

Small N for the trial means greater focus on getting the exact right patients... I’m mildly impatient, but this is not the time for the company or the clinicians to be impatient.

The main delay seemed to be getting the site and clinicians approved by the IRB, or something of that sort. Someone should ask for expansion on that at the shareholder meeting, out of curiosity.

Doesn’t have to be a short attack. Warrant holders who want to convert may need to sell shares to generate cash - we can’t assume they all have tons of liquidity laying around. We may very well see big selling pressure tomorrow for that reason. Worth at least being prepared to see that and knowing why.

But after that round of selling? We should be good. Day to day stuff hasn’t bothered me for a while anyways, hence why I don’t show up here much anymore.

Good call today. One of NP’s best outings all around.

I disagree. The only thing keeping this from moving on news is the lack of secure financing. Cash is cash, and if we can get the cash for the prostate test instead of HIV, hat actually leaves a larger stream of future cash flows intact. A licensing deal on the prostate test with sufficient up front money (reasonable opinions could differ on the definition of “sufficient”) would break the Paulson cycle and should allow the market to take over.

That’s certainly the outcome I’m hoping for. It would give the company leverage in HIV negotiations as well, which would be fantastic.

Damn. Yeah... he all but says that something is going to happen pretty soon. I think that was about as direct as he could be. Yes, he's been prone to overpromising in the past, but I think his dialogue has been coached back quite a bit recently.

That said, I still expect that there will be lag time between announcing a deal of any sort and closing the deal/getting cash. Won't be surprised to see more small Paulson raises in the meantime with the A/S we have left. I'm ok with that.

And to respond to your edit, I can understand the fear of failure from going it alone, but I don't consider that to be disqualifying. Nobody expects the current employees to have that expertise - they'd have to bring that on. Is there execution risk? For sure, but it could very well be worth it. Plus, the anecdotal evidence that "others have failed" doesn't bother me a bit, because every situation is unique.

Royalty rates in licensing/partnership deals are intended to capture the financial risk/reward ratio that a financially-sponsoring partner takes on in the development process. I.e. the more uncertainty there is over the future of the drug, the higher the royalty split for the BP would have to be to compensate them for the risk that their financial investment will not bear fruit. And most deals are struck early in the development process, somewhere between pre-clinical and P2. As a result, most of the royalty rates heavily favor the BP, and leave the developing company with peanuts, relatively.

It's very rare that deals occur when the developing company is already in the process of filing a BLA. You can make those odds even longer by saying that said drug is novel in it's field, had never had an SAE reported in any of it's trials, and plays in a relatively big and splashy field (HIV). I don't really think there's a comp for this out there, and I'd be willing to bet that the hold up is that BP's are trying to wring out royalty rates that they're accustomed to getting, without shouldering much of the financial burden and even less of the risk. If they're unwilling to budge, I'm all for CYDY making the play to go it alone rather than just hand BP several billion in revenue annually for the convenience of not having to build a marketing team. Those that take the risk should get the reward.

I think someone will eventually budge and give "good enough" royalty rates on HIV that CYDY will bite. Maybe 50/50. For a big HIV player trying to steal market share, it's a win/win/win. Take little risk on the drug, make money, and drink Gilead's milkshake in the process. For CYDY, the real prize is cancer. The ability to keep that revenue for itself - or just dictate terms of a commercialization deal - could end up being a financial win massive implications for company value.

Please note that this wasn't written to educate you on anything, so don't feel patronized. Just putting my thoughts on paper, so to speak.

Understandable. I think another Paulson raise is absolutely on the way - all you have to do is watch the share price over the last couple of days to see that. Sells down to exactly $0.50 today, after it was below $0.50 prior to the PR's this week? There's no mystery there. Nobody has to read those tea leaves - they're punching us in the face.

As for licensing "this year"... I'll bet that's finally an adult in the room editing NP's wording. I'm more interested in the fact that they have several offers, counteroffers, leads, etc. Those things take time, and it sounds as though they've been having negotiations for at least a quarter now. I'll bet something gets done on either the diagnostic test or the HIV front relatively soon, although it may be an LOI and it could still be months til closing. And cash. Thus, the share price sits at $0.50 right now.

TNBC will happen when it happens, I'm not concerned. The data presented on Monday suggests to me that they might actually be thinking about expanding the trial. Why do only TNBC when it looks to be equally effective on HER2 as well? Do it right, incorporate both, etc. Even an accelerated approval pathway for cancer would likely come no earlier than (expected) combo approval, thus allowing the label expansion pathway anyways. So if you're not going to save SIGNIFICANT time, save the trouble of needing another trial for HER2 later. NP shouldn't have been so optimistic about when they would start the trial, in my opinion. It was thrown together at light speed to begin with. To paraphrase RP... the responsibility is not to fail the technology.

Interesting comments in the video for sure. I think it's a smart move. If they're looking at splitting indications - for example, licensing off HIV/GvHD and keeping cancer for now - they could very well have the cash and revenue to build their own marketing team to sell a cancer drug that, if successful, will effectively sell itself. That would mean 100% of post-royalties owed (from previous companies) cancer revenues would be kept by CYDY... I'm ok with that.

You may or may not have been here a while back for the conversation we had about whether or not CYDY could actually build a marketing team. Others shouted it down saying it was hard and expensive. I remain unconvinced that it would be beyond the company's ability if a decent/good licensing deal were to come through on HIV or the prognostic test. Either way, going down this road presents a legitimate (YMMV...) alternative to the narrative that we need a partnership with BP, which could in turn provide leverage in negotiations. The offers aren't to their liking? Fine, they'll sell the drug themselves.

I suspect that they're close to licensing or selling the prostate test, but not quite there yet.

As a side note, if anyone has the email address for the IR rep at Edison, please let them know that the proper spelling is "mechanism," not "machinism." I'm sure that whatever CYDY is paying them, it's enough to have at least one person proofread the text overlays in an otherwise well-produced short.

Excuse me, I’m incorrect on that. Samsung has another joint venture with Biogen.

Samsung Biologics is a joint venture with Biogen. Just in case anyone finds that interesting.

It’s clear that you don’t have a clue. If you’re not laser focused on executive compensation, you’re missing the boat.

In all seriousness, welcome to the board. Nice to have voices who see the big picture.

From the little bit that you talk about it, I’d have never guessed that you view it as an issue. You should probably get it over with and ask NP.

I’m familiar with the practice of insiders buying shares of their own companies. Perhaps you should do some additional research around SEC prohibitions on executives in possession of material nonpublic information conducting trading activity on their own behalf. Or research standard corporate governance practices whereby executives typically comply with rules or agreements set by their board of directors, which are typically more stringent than SEC regulations but may not be public.

Do you think that NP is allowed to buy or sell while negotiating potential licensing deals, partnerships, or sales? What about material manufacturing contracts? How long do you think that management has been holding any type of discussions that could be considered potentially material and are definitely not public?

You’ve suggested that you’re a lawyer. I’m guessing public securities isn’t your specialty.

You seem to mistake me for someone who can answer questions for NP. Allow me to disavow you of that notion. If you want to definitively know the answer to that question, you should ask him instead of this board.

I think that is open for debate, regarding whether or not he is allowed to purchase on the open market in possession of material nonpublic information and in the absence of a pre-existing purchase plan. I haven’t been convinced of the definitive answer either way.

Regardless, that’s a nearly complete non sequitur from the discussion.

I’ll agree with you there. He could likely ask not to receive increases to compensation.

I don’t operate on relative truths. A thing is either true or it’s not. So if you’d like, I can be very specific and say that:

Under the bylaws of the Board and the Compensation Committee, only the Compensation Committee - which is composed entirely of independent directors - can grant compensation increases to management of CytoDyn.

I’ve already acknowledged that objectivity of said directors is fair game for debate. That doesn’t make the above statement any less true.

As I said, one can question objectivity of outside directors, but not the governance structure or the process. The point is that NP cannot give himself a raise. Someone else has to do that. The same people who technically have the ability to fire him. So when people say repeatedly that he “gave himself a raise,” it’s patently false and needs to be pointed out.

Words have meaning, whether people like it or not. If you believe they’re in “cahoots,” as you say, then say that “Nader’s cronies gave him a raise.” Nobody can argue with that because it’s factually correct, and the description of independent directors as cronies is an opinion. That’s perfectly fine. Unfortunately, some on this board choose to bend the truth so far as to break it, and tend to do it slyly through careful choice of words. Or they simply disregard the truth altogether to support a narrative, even when confronted with accurate information.

Discussion is healthy, but only if it’s framed in truth. As a result, I’ll continue to call out blatant inaccuracies when I see them.

Yes, that is correct. It’s called the Compensation Committee of the Board of Directors. Guess who’s not allowed to be on it?

Any board members who draw a salary from CytoDyn. This is the definition of an “outside” or “independent” director. You can question their objectivity if you like - that’s your prerogative - but questioning the governance structure and process is asinine.

See trding’s response as well, regarding the shareholder vote and related documentation from the 14a. This isn’t exactly done in the shadows.

If you believe that NP is lying about having offers and having submitted a counteroffer, you should probably take that up with the SEC instead of this board.

Again, Pourhassan CAN NOT and DID NOT increase his own salary. You can repeat it as many times as you like, but that does not make it true. Any logical sequence of events or conclusions that follows in your mind is invalid, because your starting premise is false.

Management, including CEO Nader Pourhassan, CAN NOT and DID NOT increase their own salaries.

That doesn't mean I think he's perfect or infallible, in fact far from it. But this is unequivocally a quibble I do not have with his management, because he CAN NOT and DID NOT give himself a raise.

Just as a reminder, NP cannot increase his own salary. As a publicly traded company, that's the responsibility of the Compensation Committee of the Board of Directors, which is constituted completely of outside directors.

It's unbelievably wild speculation to state that "he knows no deal is coming" when he publicly stated just four days ago that they had submitted a counter offer in licensing negotiations. Frustration is fine - I think most here are or have been frustrated with management at times - but baseless statements like "he knows no deal is coming but his next salary increase" don't really improve the discourse around here.

Anything is possible. I tend to think that their confidence in this trial is extremely high - with good reason - and IF there’s a strategic delay it would be because they want to get a deal done first so that they might be able to uplist prior to interim cancer results.

That said, I think the possibility of a strategic delay as described in theory by either of us is highly unlikely. I’d bet a house that, due to their level of confidence, they’re just making sure that the trial results will be unassailable from any potential angle. They’re certainly hoping to apply for AA from the P2 portion, and would be wise to head off any technical challenges that would warrant a further ask by the FDA. NP most likely overpromised on the original deadline for the first injection.

But like I said, anything is possible. A boss of mine used to tell me all the time... “as long as you were thinking when you did that...” I feel the same way about the company. As long as they’re thinking about what they’re doing and why, I’m ok with it. And I believe they’re thinking about things very hard right now.

While I share your belief that the first patient has not yet been injected, I’d keep in mind that the government website for clinical trials is only required to be updated by firms annually. I wouldn’t use it as a barometer for the most current status of any trial for any company. It’s most useful for understanding trial protocols, in my opinion, or looking at the results of trials Long since completed.

Just FYI.

I'm not positive that an LOI would be material from a legal standpoint, although I would certainly consider it to be material. I'm sure that one or more of our local barristers could provide some color there. Either way, you're right that we don't know of an LOI, but the company could well know that that's the direction that verbal negotiations are headed. Further, assuming an LOI is material, and assuming that an LOI would precede any deal closing, I think it's fair to assume that even if a deal were all but in place, cash flow from the deal could still be months away resulting in a need for interim funding.

All speculation for sure, but provides a perfectly reasonable explanation for the continued small raises. On the other hand, all of us who've been around a while have used that storyline before and been burned a bit. Difference this time is that NP has publicly stated that they have offers on the table and have definitively submitted at least one counter offer. The odds of a deal at this point are far more realistic than any point in the past.

We're on the same page here, mostly just talking through it. Hit 'em straight this weekend.

Let's look at your original statement:

I'll give you the benefit of the doubt since English is a second (at least) language. That's not a personal dig at you, by the way, as my secondary language skills would like only allow me to find a bathroom. However, anyone reading that statement is going to read it as an inability to find and enroll satisfactory patients - particularly after the saga of the combo HIV trial. That's simply pure, unadultered speculation at this point. This trial is incredibly important, has been put together at lightening speed, and it's a perfectly reasonable take to think that they're simply working to ensure that the trial and protocol are beyond reproach and that the FDA agrees with that prior to starting the trial. For example, they've already had one protocol change for the 1b portion, from dosing 6 patients in each dose cohort to using a 3+3 protocol for dose escalation, which may reduce the number of patients needed in the 1b by up to half. In the scheme of things, a month (or more) delay in starting the trial is nothing in comparison to having to amend the trial midway through - this could very well be an example of the company learning from their sins of the past with the HIV trials.

A case of NP being overly optimistic with public statements yet again? Most likely. If anyone hasn't learned to process his forward looking statements appropriately at this point, that's their own fault. A case of "trial enrollment failure?" Excepting my benefit of the doubt, that's an incredibly speculative statement.

I won't continue to argue the point.

Please don't forget... that was at best.

Clearly, making massive assumptions is ok only if you have a blog to back it up.

Agreed, welcome RockerV.

I know you said "nevermind" regarding your initial question, but for the sake of others that may have the same question or even be wondering what your question meant...

There is currently no PDUFA date for leronlimab. A PDUFA (which stands for Prescription Drug User Fee Act) date is a date that the FDA commits to providing some level of response to an NDA or BLA prior to, and is generated based on the date of acceptance of the NDA/BLA filing and any special statuses of the drug. For example, BTD/ODD/Fast Track may shorten the PDUFA time frame from ~10 months to ~6 months post-acceptance. Acceptance means only that the FDA feels that the filing is sufficiently complete to allow for review... and that's when the clock starts on the PDUFA date. Acceptance (or rejection) of a filing typically happens within about 60 days of receipt of a complete filing.

For CYDY, the FDA will not make a determination on acceptance of the BLA prior to having the entire BLA, thus the company does not yet have a PDUFA date. What the Rolling Review allows for is potential shortening of time frames once the entire BLA is in. For example, even though the FDA has ~60 days to review and accept/reject a BLA, it doesn't have to take all of that time. They may be able to accept within 30 days, hypothetically, if they've had a chance to review major portions of the submission prior to receiving the complete submission. Thus, the PDUFA date could be maybe a month earlier than might be expected given only the date of the final submission of the BLA under normal circumstances. Similarly, the PDUFA date is a deadline to approve, reject, ask for more information, or issue a Complete Response Letter (i.e. you're not approved... but you probably can get there if you fix certain things). There is nothing that precludes the FDA from acting prior to the PDUFA date, and indeed they have recently approved drugs months ahead of the PDUFA date. This is one of the major benefits of the FDA agreeing to actually review the submission on a rolling basis - time frames to approval could potentially be shortened by up to several months.

Again, not intended as an education for you, RockerV. Simply clearing up the question for others who may be following along at home.

Grip,

I think it's important to keep in mind that even if a "deal" is announced imminently, it will very likely be in the form of an LOI. Much like the Prostagene acquisition, the deal would be announced well in advance of closing, allowing for due diligence by both parties, etc. So, for example, if a deal is announced on April 1, it may not close until July 1, which means the company doesn't get cash until July 1. Thus, in my opinion, the hand-wringing by some over recent - and potentially any future - small raises is overblown because they'll still need cash to get to a hypothetical deal closing. Small raises mean little or nothing in terms of the near-term prospects for a non-dilutive deal.

I'll be more concerned about the prospects for a near term deal if we see an ask for increased authorized shares. If that were to happen, I'd still believe in the company medium/long-term, but I'd have to resign myself to settling in for a potentially long and bumpy ride from here.

Care to elaborate? Or are you just going back to making baseless and pointless statements at random?

I’d be interested to hear how you came to your numbers.

Also, if you don’t find 6x average daily volume in the first three hours of trading to be an interesting break in the pattern that may signal something not yet quite public, then I’m not sure what to ask or tell you. 2.6mm shares today may not break the cycle... yet.

I’m sure that’s possible. I’m assuming they’d rather not PR something significant after hours on Thursday or on a Friday. Those tend to be “bad news” time frames, historically. I’d also wager that a PR regarding a deal would be released on the partner’s terms, assuming the hypothetical deal is with a BP. So who knows how news would be released?

I’m just assuming Monday based on volume seeming to be driven by buying rather than selling, and companies tending to like to release good news early in the week. I’ll take good news whenever they want to release it!

Lot of smoke here.

Betting something is on fire come Monday.

“Don’t believe everything you read on the internet.”

-Abraham Lincoln

Which is why I took the liberty of emailing the Susan G. Komen Foundation and the National Breast Cancer Foundation to ensure that they were aware of the trial. No guarantee that got past an initial inbox though. Perhaps someone who uses the newfangled social media outlets (twitter) could tweet the PR to some similar organizations?

I’d suggest understated language and letting the PR/results speak for themselves. We all know from listening to NP how grandiose claims are perceived by those who lean towards skepticism!