That's right. In my (non-physician) mind, today's release of the data synopsis significantly derisks the investment going forward. OTC traders are going to OTC trade... That's fine. I'm here to make vacation home money, not beer money. I'll wait.

No kidding. I was happy with picking up another 20k just now, haha. 10M is a stash.

Could be, which would be amazing. I'm not sure if we ever got clarity on the status of those trials after the PR that suggested that other preclinical trials would be starting soon, etc, as opposed to already in process. I feel like someone talked to IR and got an answer, but I can't recall and it's not critical to my investment decision, so I'm not going back to search for it. I'm confident in the success of this investment at this point, and for way more than 10 cents.

Could just as easily be a financing deal, or FDA news (the SRO thing is still EXCEPTIONALLY odd to me, in a good way), or something with Cytotronics (which has been very quiet lately). I just like to align incentives when viewing situations like this, and the only way I can make the Friday PR make sense is if they have more - and bigger - bullets in the gun, locked and loaded.

Either way, I think anyone who sticks around for the long haul here is going to be in for a heck of a party at the end of their investment horizon.

I've got a feeling that the presentation that they uploaded isn't the whole show. While it is, in my opinion, convincing evidence of efficacy, they have or will have more information on hand (e.g. cytokine data). To me, this provides a potential answer to the legitimate question of "why Friday?"

If they have more to put out there that's even MORE convincing, they can do that on Monday morning, or Tuesday, or whenever. By putting this out today, they just got on a ton of folks' radars - see the number of posts on this board today, and posts by new faces in particular. Now that they've engaged radar, they can drop news even more effectively. I don't expect anything early next week... but it wouldn't surprise me either.

No problem. Somewhat surprised that one was deleted on this particular board, but that's ok. Glad you saw it. Stick around a bit and those who are worth listening to will become obvious.

We could quibble on time frames, but I don't really disagree with much here. The bigger point would be that most don't expect to see CytoDyn take this drug to market anyway, and the delays from the FDA yesterday change very little in terms of when I believe the investment would be significantly derisked for a BP. I've never expected to see CytoDyn generate revenues, or honestly, even get to the BLA step for mono. With mono open label, and interim PE results from combo likely released in a matter of weeks, I just don't think much has changed fundamentally as a result of the meeting yesterday. Hopefully I'm correct.

Yeah, I think any serious conjecture on how much this will help will just have to wait until we get details on the criteria. Towards the end of the study though, they were enrolling ~3-4 patients per month. I don't expect that this would slow down significantly with relaxed criteria, so I'm thinking 2-3 months at the long end to fill it to 50. But again, not what I'd call serious analysis here.

I'm not sure that's a question that anyone outside of the true know can effectively answer, but my thought process would be that it depends largely on what the "relaxed criteria" actually are. I'm assuming that the company has kept a record of rejected patients who were screened, which would be a logical place to start looking for any patients who fit the bill. That might make it pretty simple, really. The relaxed criteria could be a simple as lowering the number of drug classes they have shown resistance to in the past, in which case it wouldn't be difficult to transition into recruiting from that pool of potential candidates.

Actually, I'm struggling to come up with criteria changes that would present a large issue for the trial sites, but maybe I'm out of my depth here. Definitely would be interested to hear what others think on this one.

Agreed, not the news I was hoping to wake up to this morning. Also not the worst it could have been. Unblinding the data is potentially a big thing in terms of derisking the trial and raising money on better terms within weeks. I'll be interested to hear a discussion of this meeting on 10/19, just to get more context.

Not worried at all here, though admittedly slightly disappointed that we didn't get a full green light yesterday.

I never said that there was no way you were right, just that there was another way to look at the information we had. In all, I think that the news is more neutral than negative (market reaction seems to agree), but that's neither here nor there, and certainly my interpretation.

The one thing I'd respond to from your post is "interim analysis at 40 patients - was not part of original requirement". This clearly isn't an additional "requirement" placed on CYDY. This is a bone thrown to the company and to investors. Among all of the very reasonable things that we all can and have debated on this forum, efficacy of the drug itself is about lowest on the list. The evidence we have, from all of the previous trials, is that the drug works pretty well most of the time. This will allow the company to put out interim data, including the drug vs. placebo analysis, within several weeks, regardless of the minor delay in the trial overall. In terms of news that will derisk the investment significantly (i.e. actual results), this is nearly equal to the FDA saying that 40 patients was sufficient, go ahead and unblind. This part of the PR was markedly positive, in my opinion, and likely why the market shrugged off the small delay.

Another 10 patients in combo and more patients in mono (for safety, and who were going to be enrolled and dosed anyway) does mean a slight delay, but positive interim endpoint results would likely result in the ability to raise funds on much better terms. Then an additional month or two to get combo fully enrolled is far less painful, unless you need your returns ASAP.

That's actually a really good point JPG77, and one I admittedly hadn't considered. That's a completely possible outcome from this meeting, and I'm honestly not sure why that hadn't occurred to me. Still hoping for a PR tomorrow morning, but now won't be completely surprised if we don't get one.

Agreed that there's no one correct way to view it. Your professor's point is valid, of course, and context on your investment perspective - choosing risky biotechs followed by rejecting based on negative indicators - does help inform why you choose to interpret data the way that you do. I definitely have a different approach to choosing investments, and that colors how I view the information we have.

All I've tried to do in my responses to you is clarify why the overwhelming response that you got on the board was that you were overly negative in your assumptions. I think we can put it to bed at this point. Once more, good luck today!

While it's completely fair to question what "the next few weeks" means practically, I find it hard to believe that a company that has been publicly penitent for missing deadlines would provide something so vague and actually mean a month or more. If results don't come in October, and no sufficient explanation is given, I'll be deeply disappointed in management. And I think that would be fair as well. Just my two cents...

Anyone have any information salient to my previous post on this board re: why Endonovo would have been included on the FDA SRO list at this point, and what that might mean?

Oh, and who is Dr. M?

I know that others have responded to your post already, but I just want to reiterate a few things. Not to turn this into a argument over logic, but yours if flawed in several places.

1) News of ODD for GvHD didn't trickle out and spread too fast. There was an immediate market response upon that PR. Does news trickle out sometimes? Sure. I don't believe that it does all the time. As for the depressed share price, this ticker has barely traded recently. 150k average daily volume for the trailing 10 days, and that's inclusive of the higher volume day or two post-ODD. In other words, it doesn't take too many people like you - no offense meant there - who see things negatively and want to cut exposure to drop the share price 5-8 cents or whatever. That's fine, completely your prerogative to manage your investment, but it's easy to see how limited activity of that sort could depress the share price of a thinly traded ticker awaiting a key meeting. Doesn't have to be negative news trickling out.

2) The August 9th PR said "more than 100 patients" in mono. That number is not coincidental, as you're well aware. They shared the amount of information that they wanted to at that point, because it gave an outside limit on the timeline for the safety data needed for the combo BLA. I don't know how many patients they had on August 9th, but assuming that they had 100 and extrapolating a timeline from there gives you, at best, the outside limit of the timeline, assuming static enrollment rate. That's another flawed assumption, by the way. Never seen a clinical trial that doesn't enroll more slowly in the beginning, while the company is getting trial sites up and running, informing the community, etc.

3) Your assumption that the GvHD trial must not be going well since they provided an updated timeline on mono but not GvHD is simply a non sequitur. They weren't required to share information on either, and they shared the information that they felt was most important and that they wanted to share. You could assume that it's a negative omen, and anyone else could assume just as validly that they have positive news there that they're waiting to share until they want to do so. One doesn't directly follow the other.

4) Assuming that an average behavior or practice regarding the voluntary release of key information will stay constant for a particular firm in a particular situation is completely unsound logic. Let's use an example; and here, I'm going to completely make up numbers because it's only a demonstration. What are the odds that the average American contracts lung cancer in their lifetime? Let's say 1-in-75. Now, what are the odds that a coal miner in WV who smokes two packs of cigarettes a day contracts lung cancer in their lifetime? Probably 1-in-4, or something like that. Generalizations are great when looking at large populations, but when you're looking at a specific instance within that large population, it's important to look at any differentiating factors. Like being a P3 clinical biotech, days from a key meeting, with several potential catalysts coming in the next several weeks or months, and having to release a 10-Q. The information that they choose to release in that 10-Q may or may not coincide with what you believe is consistent with biotech and specifically OTC. Strategy is far too important at this stage to blindly (no pun intended) release data points and projections.

All of this isn't to say that your projections will be wrong in a week, month, or year, when we have all of the data. I'm just saying that your premises are completely flawed, and that's why you're getting such a negative view. Yours isn't the only way to look at the information in the 10-Q (or previously released information), and I'd go as far as to say that your logic does not follow on many of the assumptions that you make.

Either way, good luck today!

Amateur, you are reading the 10-Q correctly from a factual perspective, but you take the absolute most negative reading of your "three key points". If I read it the way that you do, I'd be out of this stock. Allow me to expand:

1. The language related to Oct 12th meeting - discuss open issue related to adjunct therapy - we will know very soon

You expand on this later to essentially say that this can only mean bad news because the company "expects that the outcome of the meeting could have a significant impact on cost estimates and time...". I understand your point of view, but also think that the company is basically putting this in there to allow for that possibility. I think that there's a very good chance that this meeting has a positive result, and this language is basically indemnification for the company. A bored lawyer whom I know happens to agree, for what that's worth. It's simply the kind of language a responsible company puts in an official filing regarding an upcoming meeting.

2. The monotherapy - no positive mention of patient enrollment speed - in fact they are talking about increasing no of sites and possible impact in overall costs. Enrollment to be completed in 2018 - could be end of 2018 + 48 weeks to get topline - so we are looking at end of 2019 just to get topline

It's true that this is a change from the previously stated goal of enrolled fully by 2017... but why would you immediately shift to the possibility of it being the END of 2018? Is it possible? Sure. Is it likely? I don't think that anyone who read the August 9th PR where they stated that they had over 100 patients in mono already would reasonably read a delay to 2018 as the end of 2018. Especially after they ostensibly, per their own statements, focus more on mono enrollment once combo is tied up.

3. GVHD trial - mention of 1st patient enrollment but no mention of progress or possible end of enrollment - like 2018. That tells me that it is not going well.

Why are they required to give you an update on enrollment in a 10-Q filing to assure you that enrollment is going as planned? That's the sort of thing that most companies PR selectively, and it's not required reporting for a 10-Q. You COULD assume that this means it's not going well. You MIGHT even be right. I think that it's much more reasonable to assume that they would prefer to hold on to information that is potentially valuable to them in a PR for a time where they feel it would be most impactful, particularly since they don't have a history of giving detailed enrollment updates in SEC filings.

Hopefully this helps to clarify for you why everyone thinks that you're being so negative. I'm not sitting here saying that I'm positive that tomorrow's meeting is going to go awesome and we're all going to be rich on Friday... all I'm saying is that on the spectrum of ways that you could possibly read the information in the 10-Q, your interpretation is about as far to the negative fringe as you could possibly be.

Good luck to everyone tomorrow, here's to hoping that we have good news no later than Friday morning.

Open question - does anyone have any insight or theories as to why Endonovo was added to the FDA's SRO list? I recall someone mentioning on here that it was odd that ENDV was listed, but not PLSE. I'd tend to agree. It seems like a slightly odd - and highly favorable - event for ENDV to my untrained eye. Thoughts?

Sorry if this has been discussed further, I was off the board for a few days and posts from several days ago are pretty buried at this point!

You're missing the point when you reference missing deadlines and lack of communication. They don't HAVE to reverse split, and the assumption is that they WOULDN'T unless they had the news in hand to back it up. Authorization to execute a reverse split isn't a guarantee that it happens, or a guarantee on timing if it does. Previous missed deadlines don't bother me in the slightest with regard to this particular conversation. If you think management would execute a reverse split without the news in hand to drop afterwards, then I would strongly suggest that you not invest in this company.

Sorry things haven't worked out with your other ticker, but you've said nothing to change my mind about my logic. Revenues aren't net income, and don't serve as any real indication of potential future growth. As a standalone metric, they're barely an indicator of the health of a company. Plenty of companies with revenues are failing companies. Plenty of companies without revenues - particularly clinical stage biotechs - have bright futures. If you don't understand this distinction, I'd be happy to walk through it in depth.

My pleasure. Can't wait to see this all play out. Hopefully it's good news late next week, and we get some momentum going!

I agree. I don't have the data on hand to back it up, but logic tells me that the vast majority of short attacks following a reverse split are in cases where the company is failing to begin with, not where a company is primed to unload a ton of positive news. Not to say that nobody would be shorting CYDY after a R/S, but it seems to me that shorting would be an incredibly dangerous game to play at that juncture.

I agree that I'm for the resolutions in the proxy. Reverse splits get a bad name because most are executed by failing companies, and thus they eventually fail. It's tautological - failing companies fail at an exceedingly high rate. However, we wouldn't all be heavily invested here if we thought CytoDyn was a failing company. Well, at least I can confirm that I wouldn't be invested here if I thought that.

Since we think this has legitimate, lucrative prospects, I feel we need to give management every available tool to generate the most momentum and value possible through a potential series of key catalysts. To me, that includes the ability to reverse split for the purpose of uplisting to the NASDAQ in the event that share price doesn't warrant the uplist organically. Some might say that they don't trust management with the ability to reverse split with large ratios, etc. I go back to the same sort of logic - if I didn't trust management to run the company well, I wouldn't be invested here.

We want to be on the big stage when we drop big news. Obviously, my opinion!

In the 4/18 investor call, Burger stated that they expected enrollment in the GvHD trial to take 6-9 months from the start of the trial. The PR for first patient treated was on 5/17. I suspect that enrollment rates increase as trial sites get up and running and, hopefully, word gets around about the trial. I'm guessing they're shooting to be fully enrolled by year-end.

My pleasure, glad you found it useful. Information is half the battle... or knowing is a good thing... Something like that, anyway.

I thought that was what you meant, but wanted to be clear for anyone else reading. And I agree, this would be a nice segue into good news from the FDA, wouldn't it? I'm slightly surprised by the price pop this morning, but more than happy to see it!

I'd love to see it, but don't expect fireworks this morning. I've watched several tickers show almost zero reaction to receiving ODD for their lead drug - although this may be different due to proximity to other catalysts training more eyes on Cytodyn. Regardless, we'll see value from this on the back end at a minimum. I think it, as previously mentioned, forces any potential suitors to give more credence to the GvHD franchise as a value generator. It also reduces our expected costs by a couple of million due to fees waived, etc, so helps value if anyone is actually computing a present value of expected cash flows, etc.

All in all, still great news and I'm happy to hear it!

Actually, it's 200k patients. Interestingly with GvHD, if the drug is sufficiently effective, it would expand its own market by allowing transplant procedures that were too risky previously due to prevalence of rejection / GvHD. And if it's effective, it would gain market share here very rapidly since there's not much else in the way of treatments.

Using the previously stated market potential of around $500mm... if it were to gain 40% of market share at its peak and pull in $200mm annually, that would equate to a starting point for valuations of around $600mm using the basic rule of three times peak annual revenue. This would of course be discounted for risk and other considerations, but compare that to our market cap now.

I'd say it moves the needle.

Edit - I dug up the numbers.

Those estimates on likelihood of approval are a bit high, but historically ODD drugs are approved at a significantly higher rate than non-ODD. Conditional approval rate for a P2 ODD drug - meaning the all-in likelihood once the drug has reached P2 - is probably more like 33% as opposed to around 15% for non-ODD. See page 16 of this deck, which has a TON of useful stats on approval rates:

https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf

Either way, it's a big deal. Increased likelihood of approval, enhanced market exclusivity terms upon approval, reduced application fees saving millions of dollars... all really good things. And we already know that the drug is safe, so all it really has to do is provide some efficacy for an unmet medical need. Although not explicit in the rule, there's a feeling that the FDA has been easier on the efficacy standards for ODD in recent years. The safety data that we already have gives me confidence that the likelihood of approval here is actually far higher than the 33% historical rate for P2 ODD drugs . In all, very happy to wake up to this today.

Not quite right... he's secretary for the Board of Directors, but he's also still SVP of Oncolix. Small, but important, distinction there.

This was just a necessary move for uplisting to OTCQB, and eventually higher, as I understand it. I'm sure a bored lawyer could be more definitive.

Thank you codaras, this is extremely helpful. Appreciate the welcome and the response! I agree that going out of his way to state that it is under active review is a potential, even likely, tip off that additional information was not required of ARTH, or at least any requests have already been fulfilled.

Again, thank you for the helpful response!

If I wanted to shake weak hands, I'm sure I could do much better than that. Im not new to biotech, but I am relatively new to device approval processes. I'm simply looking for information from people who know more than me - clearly, you're not that person since you failed to address my very simple question. I'm sure someone else on this (apparently quite cordial, overall) board would be happy to provide actual insight regarding my actual question.

Don't worry, several other regulars on this board know that I'm not a troll. You didn't hurt my feelings, and it wouldn't matter to me if you thought you did.

Question for the board...

The 90-day goal for returning judgments on 510(k) applications is exclusive of any time required for the applicant to fulfill Additional Information requests as determined by the FDA. The 90-day clock stops during such times. I have no reason to believe that the FDA issued an AI request, but I also doubt the company would PR if the FDA did ask for additional information.

My question is this: has anyone seen a 510(k) application where a company has made it public knowledge that the FDA has asked for additional information, thus informing investors that the timeline was extended beyond 90 days? I'm just asking for context and clarity on my own behalf - again, I have no reason to believe that the FDA has or hasn't asked ARTH for information. The pure numbers do, however, suggest that the majority of applications require more than 90 days.

https://www.emergogroup.com/sites/default/files/emergo-fda-510k-data-analysis-2017.pdf

I have no dog in this fight (yet), so please don't assume that I'm trying to stir the pot. Just trying to learn. Appreciate any insight you may have.

There is a difference between the data existing and management (or anyone else) having access to it. One week of data exists for 30+ patients at this point, but management does not have access to it because they have not locked the trial. That data is still blinded, unequivocally. A blinded trial doesn't mean that you don't see the data for, in this case, one week. It means that you don't see the data for the blinded portion until you lock the trial and compile data.

The statements you pulled from the April call made the assumption that they would close the trial at 30 patients (i.e. "complete enrollment", in the quote from Tony). They are still enrolling, therefore they have not closed the trial, and they cannot see the first week of data.

Don't be fooled into thinking that they have the data from the first week. They simply do not, and that's not a matter that's really up for debate since the trial is still enrolling.

Correct, thanks for that clarification Saltz. I meant that the trial has not been locked and the data is inaccessible - sorry for any confusion!

I've been pretty quiet around here lately because there hasn't been much to say, but I'll repeat myself one last time...

Your guess that the 1 week results from 30 patients was less than satisfactory is patently, demonstrably false. This literally cannot be known, because the trial is still locked and blinded. The FDA could not have asked for these results with an ongoing, locked trial. It is functionally impossible for your guess to be the current scenario.

I'm certainly not suggesting that I know exactly what's going on, because I don't. I've just heard that speculation about bad PE's and the company regrouping and everything for so long, and from so many posters, that I feel compelled to make sure that everyone is fully aware that this scenario cannot be true at this point. Nobody, and I do mean nobody, has that data available. I do honestly apologize if this response comes across as overly strong, I just want to make sure the point is heard.

In other news, I disagree with your take on the face-to-face being a bad thing, but that's pure speculation and opinion on my part. To me, it just means that the FDA is taking the meeting very seriously, and that could go either way. I do agree with you that if we get bad news out of the FDA meeting, we'll likely see some update on the mono trial. We could even see some early efficacy data, since it's open label. The company could also throw in an updated number of patients who have finished the 24-week segment of the combo trial, along with (hopefully) still pristine numbers of patients showing undetectable viral load and on rollover.

Either way, here's to hoping for a good readout on 10/12!

Especially when you have to take it on faith.

I'm not sure that this has been posted before, or maybe I just missed it. Interesting either way. I don't know anything about this particular conference outside of what I could glean from the website in 30 seconds. Any interesting context or experience to add?

I appreciate that Cynmark, thank you. That's how I'd generally define cheerleaders on these boards as well. In this case, I've been pretty vocal about the delays and changes not giving me undue heartburn, and since that seemed to be the angle of the original post, I felt slightly called to provide my thoughts.

All the same, appreciate your sentiments and I'm glad that you feel I add some value to the board!

I'm assuming that you consider me a cheerleader...

Although I'm not happy about the developments, this is exactly what I've been saying all along. They were talking to the FDA, prior to unblinding with 30 patients completed, in order to ensure that they have exactly what they need for the post-trial proceedings to go smoothly. I'm glad that they're doing what they need to do to get the FDA the data they want, rather than just closing the trial at 30 and hoping for the best. Nobody likes delays, but this seems prudent.

The PR isn't overly clear on a number of things, but I know for a fact that it said nothing about either of the two things I care about most:

1) There is nothing in the PR that leads me to believe that efficacy is in question. The only data we have on efficacy is that it works very well for at least a large portion of the trial population to date.

2) There is nothing in the PR that leads me to believe that any safety issues have arisen.

So, from the cheerleaders... nothing of high importance has changed, and I'm waiting - admittedly somewhat anxiously - to hear more information from the company. I'd much rather them be cautious and prudent with this trial, even if it means more slight delays and raising more money at an unfavorable rate. It would be catastrophic to proceed without FDA sign off and blow this trial on some technicality that could have been easily addressed through taking their time and working with the FDA. Since fred or someone else will bring it up, of course the company doesn't NEED FDA approval to do anything at this point - it would just be silly not to be in lockstep with the people who ultimately make the decision.

If I'm hearing fred's argument right, he's saying that the need or desire to PR a meeting with the FDA post-P3 trial could only be driven by lawyers insisting that a company do so, and therefore must be a red flag.

I think that argument is insane. That doesn't mean I'm happy to see protocol changes, but come on. The company has always said it would meet with the FDA to discuss BLA after the P3 completes. A PR that they're following through with their plan must be driven by lawyers? From the 4/18 call (bold type mine):

Yi Chen

Thank you. So as of right now, the projection is still that the BLA for PRO 140 as a combination therapy should be submitted by the end of this quarter. Is that correct?

Anthony Caracciolo

That’s correct. I believe that’s still our goal. Now, I think what’s important to mention is that although we have had several very positive meetings and discussions with the FDA, we have not met with them to discuss our regulatory pathway for submission of the BLA. I think that’s still in front of us. And once we have all of the data compiled from the combination trial, our plan is to then to sit specifically with the FDA for a pre-BLA meeting and discuss with them the details of our application which will consist of three significant parts, the clinical, the non-clinical and the CMC section that Mike referred to.

Link to the transcript: https://seekingalpha.com/article/4063244-cytodyns-cydy-ceo-nader-pourhassan-hosts-investment-community-conference-call-transcript?part=single

So seriously, if you think that the a) getting a meeting on the calendar with the FDA that the company announced back in April was part of the game plan, and; b) lawyers forced the company to PR said meeting with the FDA are RED FLAGS!... then you're so completely off base that no amount of reasonable discourse can help you. Again fred, I think you're stretching very hard to find the negatives. And here I'll repeat, the changes to the protocol don't make me all warm and fuzzy. But the meeting with the FDA? Always part of the plan.

Definitely an interesting change. Hopefully they talked to the FDA, but on the other hand, the exclusion of previous Maraviroc use sounds like a protective clause for Cytodyn - ostensibly, you'd want to avoid that in case patients developed some resistance to a CCR5 inhibitor class drug prior to using PRO 140 in the trial. That's speculation on my part though.

I still have no doubt in the science or the efficacy of the drug, but I'll admit that I don't like seeing an unannounced change in the protocol this late in the game. Misiu or others with experience in clinical trials, care to weigh in?