Obviously depends completely on what one thinks the cancer indication is worth in a BO scenario. Gilead currently has about $31b in cash on the books. If leronlimab shoots out the lights re: cancer and makes it to market as a platform drug for first line? No, I personally don't think $31b is enough. Bristol Myers-Squibb picked up Celgene for $74b in a cash and stock deal though. Acquisitions can be financed. It could happen, even at the top end of "I'm never going to work again" level of optimism valuations.

However, I doubt any company would bet the farm like that on one drug that's not even on the market yet. Much more likely to be a very friendly partnership, and maybe a buyout down the road if it all pans out and revenues are flowing. Even if a BP went a little wild and gave CYDY something like $2b upfront and 60% of all future revenues... that's a tiny, survivable bet compared to chucking $30b or something at the company for the whole show when, although HIV is significantly derisked from a clinical perspective, nothing is on the market yet.

All that said, there's nothing to say that CYDY wouldn't take $15b and run. From a balance sheet perspective, plenty of BP could make that happen if they so chose. As silly as it sounds (~100x return from here???), I think that would disappoint a lot of us who want to see what it can do in the cancer realm.

In my mind, this is the core reason that CYDY still exists as an independent company. Once leronlimab became a legitimate acquisition target from an HIV perspective, the company knew cancer was a potential and the asking price went through the roof.

Great catch, and great question for NP/RP. Massimo Cristofanilli was the oncologist who was originally announced in connection with this trial.

I appreciate it SammieGo, but she gets tired of hearing me talk just the same as I'm sure that many of you do.

Aside... yes, the newcomers and noise are absolutely just part of the deal. People check the breakout boards (most posted on for iHub) and migrate to them with a variety of intents. Par for the course.

Fair question. Personally, I believe that strong interim results will render those official timelines irrelevant. Typically in oncology trials, the FDA allows primary endpoints (generally a measure survival horizon), secondary endpoints (often progression-free survival), and in some cases surrogate endpoints (again, PFS is sometimes used - this trial will be offering up CTC counts). The purpose of having these additional endpoints is to allow the FDA to potentially move faster towards approving drugs in situations with severe unmet medical needs, and is based on the assumption that surrogate endpoints are a reasonable proxy for or predictor of clinical benefit (survival horizon), but they can be measured much, much faster. This is the basis for the Accelerated Approval program, and oncology is the primary target/beneficiary for AA due to mortality rates and lack of effective treatments for many indications.

So how does that functionally work, and what do the timelines mean then? Well, the FDA will likely watch this trial with extremely keen interest due to the safety profile of the drug and the target (TNBC). If the FDA is impressed with the interim numbers for CTC counts, it is very possible that they will ask/allow the company to submit data for review and approval under AA while the trial is still going. The AA process doesn't stop the clinical trial process - it just allows a drug to get to market much faster while the FDA requires the company to complete in progress and, usually, post-marketing studies to demonstrate the clinical benefit and safety profile. The FDA can then revoke approval if the subsequent trials don't prove benefit, or have unacceptable side effects, etc.

If necessary, I can provide examples of where the FDA has intervened during P2's and approved drugs under AA. Google searches will get you the same thing though.

In short, the only date that really means much there in my opinion is the Estimated Study Start Date.

Hey SJ, thanks, and glad you've found some of my posts helpful along the way. Spoiler alert here: I like to deal in facts, but this post is nearly 100% opinion and conjecture on my part.

To your first question, I'm still not sure what the answer is there. The conversation last weekend produced some examples of companies successfully building sales forces (thanks A17), although I haven't had time to research what exactly went into that and why they were successful where others failed. Finesand eventually threw a massive range of a number ($50-150mm??) for another company's efforts... but in the same breath conflated it with the money the company borrowed to continue its drug development program. Everyone else just yelled real loud and then patted EponymousKook on the back for saying nothing. So... I really don't know? I'm still curious as well. While acknowledging that I don't fully understand what goes into it, I still fail to see the massive expense or difficulty in building a sales team. It's not rocket science, and the drug would damn near sell itself. I do have relatives in medical device sales, and I understand that connections mean quite a bit. However, it's common practice to hire away sales reps from competing companies for that exact reason. As finesand noted, a deal with a distribution company would probably be required. But that makes it even easier... you just have to build a sales team. Until I read something or someone gives me examples to the contrary, I'm of the opinion that it could successfully be done for well less than the lower bounds of the range that finesand gave from her one example.

To your second question, my opinion is that this is one of the many options that NP/RP are likely exploring, but I find it slightly unlikely. Although management has discussed the possibility of licensing or selling off individual indications, I've never satisfied myself with an answer for how the logistics of such a deal would functionally work. Legal counsel once informed me that deals would probably do little to protect the licensee's market, and that language in the agreement would put the onus to enforce market infringements on the licensee themselves. That seems unpalatable to me, as a licensee. I think it's more likely that they'd be able to work a deal to sell/license ALL indications for a country or region (e.g. sell off Japan...), but I've recently been thinking that that is likely complicated as well by differences in regulatory regimes.

To answer your second question more succinctly, I think that given the opportunity and with the right deal, they'd consider following the strategy you've laid out. However, I doubt it's the most likely option. It'd be more risky and probably would take longer, but could make huge returns. I'm sure that the company would prefer a broad, general partnership on reasonable terms given the level of risk that BP has(n't) shouldered during the development process. I think the company is too expensive for an upfront buyout right now; maybe down the road though, by any hypothetical partner.

At this point though, I doubt that we'll see any deal before we see some cancer data. I bet they were working hard on trying to find something (sell the diagnostic test, license off Japan, etc) a few months back, but then the cancer IND got sped through the FDA. That's now the single biggest piece of information that neither side of the table has - how will this perform in the cancer trial that's about to start? That's the big market, that's the key question, and I think we'll see movement after we get data. As a result, NP/RP have just gone on the fundraising trail. Notice that most of the recent conference dates have popped up late, even to the point of right before the conference. To me, that's evidence that they chose to pursue this path once the events/circumstances that I just described came to pass. The small raises, as distasteful as they are to many of us, are likely the best path forward for the moment.

Unless... Gilead gets scared after its latest failure and jumps the gun. Wouldn't surprise me. They're going to lose their HIV cash cow in a year or two if they don't get in on this, so I could maybe see them taking a swing on this before cancer data and taking the whole thing on terms palatable to CytoDyn. Preserves their cash flows and might give them the next big thing in oncology, but they'd have to make an offer the company couldn't refuse to take it all before we see interim data, and that would probably involve overpaying for HIV, either through massive upfront money or by taking very lenient terms on cancer royalties. Honestly, they'd probably be smart to do so. They don't want to have to (hypothetically) beat offers from Pfizer, Merck, Roche, GSK, and whoever else has an oncology portfolio where leronlimab would be a good fit.

I agree with you on all counts re: NP. But your business partner's reaction and story is exactly why the company needs the change at this point.

Then again, it might not matter much at this point!

Well, if Pourhassan is half as famous with the general public as Mario Mendoza when this is all said and done, we'll all be very wealthy I believe...

Jokes aside, you're correct. I'm no fanboy or cheerleader, but I do have a lot of respect for what he's been able to do with this company and this compound in a very short period of time, relatively. Soon enough, I believe that all of us - and the medical community - will own him a great deal of gratitude. But it's time to let someone else be the public face. As much as he's improved recently, and for all of the skill sets that I'm sure that he possesses, he's simply not a public speaker of the caliber that the company really needs at this point.

The interesting thing is that because it's the same compound (leronlimab) and the same formulation and delivery system (sub-cut injection, 700ml), commercialization for cancer isn't necessarily far behind combo HIV. The plan all along for mono has been to file a label expansion BLA (supplemental BLA, or sBLA), piggy-backed on combo approval, which in theory dramatically shortens the timeline for approval. In this case, the FDA will have already reviewed safety data and the CMC portion of the BLA filing. Essentially, with the safety profile leronlimab has demonstrated (and we expect to continue to see...), they'd basically just need to show efficacy. The same would apply for cancer, although positive cancer data will also be grounds for an application for Breakthrough Designation, which would speed the process further. In short, it's important to start generating cancer data as soon as possible, because the FDA is very likely to accept positive P2 data on an AA or sBLA track in this case.

Which makes combo both extremely important and very interesting. We all seem to accept that combo approval is a foregone conclusion as long as the company gets the CMC portion correct, and will be even more so upon the acceptance of the BLA by the FDA. Remember, something like 85% of NDA/BLA filings that are accepted by the FDA are eventually approved, and the vast majority of flat out rejections are predicated at least partly on safety issues. I acknowledge that getting the CMC portion right the first time is NOT a given, by the way, but should be correctable in the course of business if there is an issue. The pre-clinical and clinical data is a relatively obvious green light. But if that's the case... then acceptance of a combo BLA will be a very strong harbinger of (relatively) imminent mono approval, and (assuming positive cancer data and a continued benign safety profile) cancer approval. Not like the week after combo or anything, but much faster via the sBLA route than going for a whole new drug approval. This is why the company didn't fight harder to convert the mono trial to pivotal, by the way. The approval timeline is based on the combo timeline, so they have the time to run a small-ish trial and generate the best data that they possibly can in order to ensure that mono sails through and create the market buzz from hitting ~90% success rates in a trial or something like that.

This is almost certainly playing into why we haven't partnered for anything yet. Highly unlikely that anyone on either side of the table is going to sign anything prior to seeing what sort of cancer data the company generates. And, in my opinion, highly unlikely that a partnership doesn't materialize in the wake of positive cancer data.

It's going to be fun to watch this play out, because...

1) Good cancer data is likely to precipitate a major partnership.
2) A partnership is likely to not only clean up the balance sheet and put a halt to the Paulson rounds (crucial), but also bring Wall Street analyst eyes to CytoDyn. They're going to want/need to know who and what that company is that just partnered with Merck, or Roche, or whoever, because they need to know to understand what the BP just signed up for, but they'll also have to understand what CYDY has...
3) All of that is likely to happen in roughly the same time frame as a BLA submission for combo, acceptance of which will have all of the secondary effects I typed out above. The FDA has 60 day for an initial review period to accept a BLA or ask for more information, so there's a clock on the acceptance.
4) Analysts are going to very quickly realize the implications for forward revenue for this company.

This whole thing is like a very tightly coiled spring. When it cuts loose, it's going to go hard.

Those are pretty much my thoughts. But I think that BP is going to have to make concessions on typical partnership terms to get the nod. I don’t get the feeling that NP/RP are planning to give away the majority of revenue...

It may be 1000% percent correct, but it still does nothing other than shout "it's hard!", "it's expensive!", etc. Nobody seems willing to put analysis to how expensive or difficult it actually is, nor why other companies are seemingly capable of it but it's impossible here. And again, the idea would be to cut planned, non-essential expenditures (continue to advance combo BLA and 510k, suspend everything else save maybe the TNBC trial) and redirect capital we've already raised or could raise with current A/S towards building a small team geared towards generating revenue - however minimal compared to standing estimates of market penetration - and then use that revenue to support further R&D and infrastructure growth. If this is so impossible, how does any company ever succeed at it?

And I'll repeat once more, this is not ideal, but might be necessary for negotiating leverage unless we want to hand a majority of revenue to a BP partner simply for existing and taking no financial risk along the way. If folks think that a viable path forward isn't necessary leverage for negotiations, then this whole conversation is moot anyway.

I'm likely out of pocket now for most of the weekend, but I can't wait to come back and read all of the well-reasoned responses I get. For the record... that was sarcasm, but I would honestly love to read a well-reasoned response to the question.

I understand the point you're making, but my point is that the partnership terms that are generally entered into with small companies and BP involve large up front payments by BP to fund the development of the drug, followed by large royalties for the BP - often the majority of revenue - upon approval and marketing. This makes sense usually. BP is taking financial risk in the development of an early stage drug, and needs to be rewarded on the back end. I'm speculating, but it's unlikely that a BP is going to be all that eager to enter a partnership with royalty terms that reflect the reality of this situation:

1) CYDY has incurred substantially all financial risk regarding drug development, particularly once a BLA is accepted for combo.

2) The BP would be taking little financial risk, and would essentially just be providing sales and marketing.

If the company wants partnership terms reflective of the risk balance - namely, CYDY 99% of the risk, BP 1% of the risk - they're likely going to need to have a viable option forward without begging BP for sales help. Or at least a good bluff. With revenue and/or financing via licensing of the diagnostic, something like that, I still don't understand the difficulty of building a sales force. Clearly, other companies have successfully done it in the past.

And again, I'm still not suggesting that this is the preferred way forward. I'd love to see a great licensing or partnership deal on Monday morning. But I'd still rather the company have a strategy to pursue this path if nobody wants to offer partnership terms reflective of the risk incurred.

So, you've confirmed for me that it would be "expensive" and likely "disastrous". I understand that it's a different skill set, and obviously other parties would have to be brought in. I don't think anyone was under the impression that Pourhassan or Pestell would be running a sales team. Could you provide more color around why, say, $20mm up front this year (from capital in excess of what would be required to get the BLA and the 510k through, for example), followed by minimal revenues of $50-100mm (scaling back market penetration for combo by 90% and not even considering the diagnostic test) in 2020, would not be enough to build a sales force? I understand that some aspects of distribution would be outsourced, and I probably should have left that out of earlier comments. Also, the excess capital number is roughed out. If the sticking point is $5-10mm either way, I don't consider that insurmountable. If it's an order of magnitude off, that's a different story.

I'm trying to understand why this outcome, although clearly slower and more dilutive on the front end, would be so "disastrous" as compared to potentially handing 80% of revenue (or more, I'm roughing out numbers based on other partnership deals I've researched) to BP for doing nothing in the development stage, just so we can get a deal done. So far, I've heard nothing to provide any support for how "expensive" and "disastrous" this would be.

I've heard a few times today that building out the company's own infrastructure in lieu of taking a bad deal from BP would be "expensive" to the point of not being feasible, or simply "disastrous". Nobody seems to want to tackle why it's so impossible though. Care to enlighten me? I'm legitimately curious.

I'm also not advocating that this be the company's first choice, but as someone said the other day (paraphrasing): necessity never made a good deal.

So again, would you or anyone else care to convince me that the company should take a bad deal, that rewards BP for doing nothing other than existing, instead of exploring the option of building real negotiating leverage by slowing R&D on indications not near-revenue and using the excess capital available to build out their own sales and distribution network?

Think you nailed this one.

Define expensive. Then review the cash recently raised, plus the ~$30mm (current terms are for an average revenue to the firm of $0.30/share after warrants and broker fees) the company has left as headroom from A/S. Then consider how much cash is needed to finish the combo BLA, the 510k for the diagnostic, and maybe the initial TNBC trial. Ignore costs related to the mono, GvHD, and colon cancer trials, as they should be postponed in this scenario. I'm working on the (potentially unrealistic) assumption that strong cancer data would not spark an acceptable partnership.

How much cash would that then leave the company to hire away a few experienced members of Gilead's sales team, for example?

I believe you're overstating the cost and difficulty versus the company's capability, were they to slow clinical progress down to near-revenue activities only. Overstating the risk? Maybe not. But if the reward is not handing ~50% or more of gross revenues to BP just because they're kind enough to agree to sell a product that they've shouldered no risk in developing, I personally will take that risk all day long.

We may have to agree to disagree on this one, and that's fine.

100M shares at current terms would net closer to $30mm additional, after accounting for warrant coverage and broker fees. Still enough, but let's not overstate the headroom the company currently has. And if we're maxing out our A/S through private placements, we're probably not going to do it on significantly better terms than we currently are. Because... economics is a thing.

And regarding building a sales/distribution force... why not? I agree it's not ideal, but sales and distribution isn't rocket science. If they slow down R&D expenditures greatly in order to focus on near-revenue products, they could put together the cash (see above) to put together a small sales and distribution operation. I never said it would start as a full-scale, BP-esque roll out, and explicitly acknowledged that it would significantly impact predicted market penetration and timelines for further developments.

Working with a distributor on a limited basis may be easier, I'll grant that.

I should mention that this route would also constitute an unfortunate delay for patients in some indications. BP should consider that when being obstinate on partnership terms for a revenue stream that is essentially being handed to them with no effort on their part.

You forgot #3:

Company continues to raise money and focuses only on those items most likely to create revenue or immensely raise the company profile (combo BLA, 510k for diagnostic test, cancer trials). Partners don't want to play on terms that the company likes? Cool, just take combo and the diagnostic test to market without BP, and use the revenue to fund the remaining trials, growth of a sales force, etc. Even if we believe that market penetration would suffer greatly (it probably would), $50-100mm in revenue from combo and the diagnostic next year would do quite nicely for ensuring that the company could continue to develop everything sans further dilution.

Would it take longer? Yes.

Would it be more difficult? Yes.

Would it be a little bit risky? Yes.

Would it keep BP from taking advantage of CYDY by offering weak terms on a partnership even though BP has shouldered exactly zero of the development risk and, by the end, nearly zero of the financial burden? Yes.

We all want for the company to strike a deal and get this cruise ship moving, but we all should also want the company to strike the best deal. Usually, partnerships occur very early in the development phase (P1 or P2, sometimes even pre-clinical), and result in BP shouldering some financial risk. In return, they take a large portion of the revenues if and when a product gets to market. Here, the little guy has advanced the ball much further than usual, through a P3 endpoint for an unmet medical need, and rightfully should get a much larger share of the revenues under a partnership deal. I very much doubt that BP is champing at the bit to give the company more preferential terms than usual.

I'd rather the company slow it down, raise money as needed, and take another two years to get everything across the line - and keep the lion's share of revenues - than deal away the majority of revenue after taking all of the risk just to move things along more quickly.

I don't want $10/share for a product that may have 12-digit annual market potential just so I can get my money a little faster.

I recall Pourhassan explicitly stating during a previous conference call that there was no exclusivity agreement and that the company was free to take money from anywhere. I don't see it in my notes, but my notes only go back to the July 2018 call, so it may have been before that.

In the spirit of giving people hints for the game, the easy way to tell me and IndexGuy apart is that I'll apparently be the poor one.

(Writes down "woodenbear" as first person to find in the name tag game...)

Agreed. Regardless of the number shares I end up owning or how much they sell for eventually, I'm hopeful that the Paulson folks are willing to buy the drinks in Vegas for the retail folks who absorbed their risk. Not mad, just unabashedly jealous.

Oh, to be on the inside...

Some may accuse me of smoking whatever good stuff Pro has his hands on... but I’ll take $10/share after I see BAD cancer data. And since I have every reason to believe the data will be good? I’ll keep my shares for $10.

Don’t show Mrs. BlackDoggie this post, please.

That's immensely helpful to know, as I never would have pegged you for a Filipino woman!

(marks an "X" on own name tag, takes a shot)

Oh don't worry, that's part of my plan for the game. There will be an RSVP system for the game, so there will be a finite list of aliases.

Also, for every guess you get wrong (until you get your three x's...) you take a shot.

I think we need to play a game...

We pick a public place and time. A casino, or something like that. Everyone with an alias puts on a blank "Hi, my name is..." sticker so that we know who's playing. Everyone carries a sharpie. When you run into someone, you get one guess as to who they are. If you're right, they have to put their alias on the name tag. If they're wrong, you get to mark an X on their tag. If you get three X's, you're out of the game.

I don't know how you win, but I think we all get drunk in the end. Except tom and chump.

Mrs. BlackDoggie and I will likely make a short appearance in Vegas - honestly, who could resist meeting this cast of characters in person? - but after that you'll have to do some serious due diligence to figure out to which mountain range we've removed ourselves.

I enjoy routinely sending a friend of mine a screen shot of a text that implied we were off to the races and would never see these prices again, etc.

That was August.

However, one of these times... the broken clock is going to be correct. Is it this time? I don't know. Kind of doubt it. But we're absolutely at a point where we could get news most any day that should materially and permanently impact the share price.

I halfway expect an 8k tomorrow after hours, and a PR Monday morning. The company is definitely in fundraising mode, but moves like today have often been predecessors of good news.

Fair point, and I don't know the answer to the question. Truthfully, I believe the safety aspect (beyond helping the approval process immensely) is less impactful to combo than mono, etc. The FDA essentially required the company to do a combo trial as a prerequisite for pursuing mono. Why? The combo population (multi-drug resistance) is an unmet medical need - they're running out of existing treatment options. Patients in that space are at high risk of transmitting the virus and/or experiencing life-threatening disease progression. If you can help that population, side effects are something of an afterthought.

On the other hand, the lack of adverse effects is going to be a MASSIVE selling point in the mono, cancer, and GvHD markets.

I'm with you. Although Gilead is often heralded as the kings of the HIV market - and they do own the lion's share currently - it's not like they're the only ones who are selling HIV treatments. Notably, GSK and Merck are also players in that market and could easily scale up no doubt. I'm sure neither of them would mind drinking Gilead's milkshake in that space.

https://www.statista.com/statistics/273434/revenue-of-the-worlds-most-important-aids-drugs/

Let's not pretend that other BP don't have the inroads and that Gilead is our only hope for hypothetical market penetration in 2020.

Oh, and they both (Merck, GSK) happen to be big oncology players. Just saying.

Agree. I think that they'd be more than happy to publicly start the clock to the first interim readouts. The only thing better than releasing good news on a global scale is having people know when that news is expected and wait for it anxiously.

While I somewhat doubt that BP is significantly suppressing the stock price in this case - remember, never attribute to malice what can be adequately explained by incompetence! - there's an easy solution to that potential issue. It's worth bringing it up here.

In order to short shares, sellers need shares available to borrow. Shares that are held in margin accounts can be lent out by brokers without your knowledge or permission. Shares that are held in your name (not the street name of the broker) and that are not in margin accounts cannot be lent out with your permission. So, if you're a shareholder here and concerned about manipulation, MAKE SURE THAT YOUR SHARES ARE IN YOUR NAME AND ARE NOT IN A MARGINABLE ACCOUNT.

finesand, this post isn't directed at you at all, more just a PSA for the board at large that piggybacks on your post. While I doubt that anyone is significantly shorting the stock right now, we shareholders can be our own best advocates in ensuring that there are few or no shares available to borrow/short.

But, I do love a good short squeeze...

Yes... there are a few folks who will be getting inquiries about how their index funds are doing (no offense) when this stock plays out.

Either as a retaliatory jab, or because I'll legitimately need to know which index fund has the lowest costs, etc.

Which, ironically, I intend to do in Vegas with my "winnings" from this bet. Go big or go home, that's what I always say.

There's no confusion here, that's the story. You nailed it. Share price won't move until one of two things happens:

1) There are no more expectations of private placement shares or convertible notes, and the only way in to the investment is the open market.

or:

2) Such a watershed event occurs as to make it obvious that the stock is undervalued, bringing in hedge funds, etc. E.g. it becomes public knowledge that the company turns down an offer of $8/share for the company. Realistically, it's difficult to see that happening prior to #1, but not impossible. For example, breakthrough interim cancer data might be enough to make some hedge funds jump... but they'd still likely go to private placements with friendly terms first unless, you know, those aren't available anymore.

Both of these are different from convincing retail investors (like yourself, I presume) to jump in. Realistically, that's not going to happen on the OTC to a degree that would negate the supply driven by the rinse/repeat buying and selling of risk free shares by private placement investors who are getting warrant coverage. The math just doesn't really add up with the volume unless you start to see some real price appreciation, in which case that's probably already being driven by #1 or #2 above.

The difficult part, as one whom I converse with frequently likes to say, is convincing yourself so completely that something is at once "white" (incredibly valuable based on merit) and "black" (not valued highly at all by the market, which supposedly values things based on merit). The answer there is simple as well, but requires a deep commitment to the belief that the asymmetry of information and access on the OTC is incredibly strong.

I personally have no difficulty with this commitment. It's my entire thesis for looking at OTC stocks as viable investments in the first place.

Please stick around the board. I enjoy your posts.

I agree that they’ll likely take safety data from the ongoing investigational trial for the upcoming pivotal, and that should lead to a smaller and quicker pivotal trial. I actually mentioned that recently. But we don’t even have a protocol for the pivotal yet. The quotes about avoiding long delays in the BLA filing are all directly related to filing for combo at 700mg instead of 350mg. I imagine all future trials will borrow safety data. Cancer, GvHD, etc. Likely all smaller due to the existing safety data and profile.

At least that’s how I read it. As I noted, I expect that in the long run you’ll be correct, but this one is all - and only - explicitly about the combo BLA borrowing safety data from investigational mono.

Sorry, I just realized that I never responded to this. Given that there is still some level of uncertainty - small, but there - I’ve been sticking to the low end of forward P/E multipliers I’ve sampled from the industry. That’s put me using a number around 5x typically. If I was using a probability weighted range, I’d probably end up settling around 8x.

However, as I mentioned previously, that multiplier should go way up if you’re contemplating derisked mono, cancer, and GvHD indications that just haven’t quite crossed the finish line yet. Not saying those are derisked, obviously, just speaking in hypotheticals.

Am I missing something? I don’t see anything in the PR about the pivotal mono trial. The FDA is allowing the company to use patients from the investigational mono trial (and others) who are on the 700mg dosage as safety data to submit a BLA for combo approval at 700mg instead of the original 350mg dosage.

I still take the FDA actions as positive and being favorable for the company, but there’s nothing I see that is specific to the mono pivotal trial.

In all seriousness, feel free to come back with legitimate clarifying questions, etc. Many of us have spent years following this extremely closely, and are happy to help with historical context or nuances that the readily-available materials don’t effectively cover.

If he were at the Noble conference, he wouldn’t be asking (seriously) if the company was involved in anything besides HIV.

New folks with legitimate questions are welcome. We’ve had a lot of those. I was one, once.

New folks who refuse to do their own initial DD - or at least pose questions suggesting that they haven’t, while simultaneously intentionally framing statements negatively - are not. At least in my book.