If you assume that the end game is a buyout, which most longs here do, then this is not a dilutive move at all. Yes, it adds shares to the float, but those shares would already be exercised (contractually) under any buyout, so this doesn't impact per share value in a buyout scenario one bit. If this works out as I think management assumes it will (wooden bear laid out the logic pretty well), then this is not a dilutive financing in any real sense.

Your logic on waiting for the last big dilution always made sense, Fred, even if we disagreed on details... but I think you've missed the boat on this one. Time will tell!

Bucky, I would have agreed with you if there was no time limit on the offer. With the time limit, it's clear to me that management plans to release positive news that will make it clear to warrant holders that they will eventually be exercising their shares. The limited time discount gives warrant holders a material reason to exercise now, thus providing cash to the company in a nom-dilutive manner, instead of just continuing to hold the warrants and exercising later. This hopefully avoids needing to raise funds immediately after releasing good news. Without the limited time discount, the warrant holders wouldn't be incentivized to take the additional risk of converting warrants to shares, since they actually have to front cash at that point. Without the time limit, this would seriously concern me.

Whatever we find out next week is going to be rock solid regarding convincing warrant holders that their shares will be worth significantly more in the future. And it also signals to me that the company thinks that $12mm or so would carry them a LONG way towards the finish line. I guess we'll see for sure soon enough.

Thanks JPG, a bored lawyer confirmed it for me. With the time window instead of an open-ended offer, I can only read this positively and I expect news Monday.

JPG, I haven't read the filing and can't any time soon - can you confirm that the drop to a .50 exercise price is for 30 days only? If that's the case, then I think that this is a very, very positive development. Open-ended, and I'd be more skeptical. Thanks in advance...

Agreed. If only "slander" and "libel" had any meaning here...

You as well! Regardless of our position here, I think we can all be thankful that we have the resources to be investing at all. Happy thanksgiving all!

Generally correct, but check your details. The primary endpoint is actually a fraction of a log reduction from the pre-treatment measurement. Your 40 copies/mL figure is more strict than necessary.

However, that's exactly what the company has claimed that patients have been reading at the end of the 25-week trial... which is fantastic.

Nice that they took the time to have it peer reviewed. That's meaningful. Hopefully this is the opening salvo of a news cycle.

That would be a very simple answer - if the data was available, that is. There is zero indication that any data on primary endpoints was available, since it's a double-blind trial and it had not been unblinded at that point. In fact, one of the big concessions from the FDA was that CYDY could unblind data on the first 40 and conduct interim endpoint analysis.

Plain and simple, the FDA didn't have the primary endpoint data on 10/12. Unless we're all being blatantly and openly lied to by both the company and the FDA. If you want to argue that they were suggesting that the open label portion of the trial (24 weeks in conjunction with optimized background HAART) is what the FDA was looking at, I can accept that as plausible and still disagree with you.

Sounds like we're largely in agreement on our suspicions. Hope we're correct!

I don't disagree with you at all, ahab. My suggestion is that requiring an additional 10 easily accessible (if you believe CC timelines) as a stall tactic by the FDA wouldn't be all that effective. That's what makes me think that this was something different altogether. If they FDA wanted to seriously stall, then they require another 30, or don't accept the current 40, or require a new trial... Stalling things by a couple weeks isn't exactly a coup de gras.

My opinion, of course.

What data, indeed? I'll get to that in a bit.

After reading up on the difference between statistical and clinical significance after that call, I think that this distinction supports my stated hypothesis around the company asking for broader labeling. Essentially, clinical relevance or significance is a squishier topic that statistical significance. The latter purports to show the likelihood that the outcome was due to chance, and thus unlikely to be repeated in future studies. Statistics is, of course, a highly-developed area of mathematics, and the basic principles of statistical power for small, simple experiments are broadly agreed upon. I think it's safe to assume that both the company and the FDA had a uniform understanding of the statistical power of the trial design from the outset.

Clinical relevance, on the other hand, seeks to answer questions like "how big of a difference is there from the control?" Or "do the side effects or risks justify the difference"? Or "is the result enough to get physicians and patients to change practices"? In other words, highly subjective. The least subjective part would be "how big is the difference from control"? This is something that is essentially negotiated during the construction of trial protocol and the definition of primary and secondary endpoints. The FDA agreed to the protocol from the outset with regard to the required reduction in viral load at one week, and did not change this in the October meeting. Therefore, I don't believe that this portion of it was actually in question during that meeting, and therefore isn't the issue when they reference clinical relevance. This is supported by the fact (unless everyone is simply lying to us) that the data was still blinded, and the FDA could not have seen the data to determine that the observed difference was not clinically relevant.

So what could the FDA now need to see, in terms of trial design, to confirm "clinical relevance"? Here, I'll reference my previous post where I hypothesize about the patient population, labeling discussions, and the relaxing of criteria for the additional 10 patients. In short, however, I think that for the FDA to deem the results "clinically relevant" in a broader patient population, they had to see at least some patients treated who fit that patient profile. Clinical relevance is just the semantics used to cover for the (hypothesized) fact that the company handled the overall negotiations and ODD application poorly from the beginning.

As for the question of "what data"... again, pure speculation. It's clear to me - and this is in no way meant to belittle Dr. Pourhassan - that Nader's first language is not English and that he is not a terrific speaker. In fact, if I were Tony, I don't think I'd let him speak on investor calls. Since (I assume) that the primary endpoint data was still blinded, my take on the comment you highlighted was that Nader was referring to the patient profile of the 40 enrolled as "the data". When the FDA looked at that, they then said (in my hypothesis) that it wouldn't provide clinical relevance for the (assumed) broader ask re: labeling.

Tons of speculation and assumption here, obviously and admittedly. It's just the scenario that I find best fits with any and all facts that we, as investors, think we know.

I'll also add that the additional ask regarding patients for safety data may appear out of line with that reasoning at first blush. However, if I'm the FDA, and I'm agreeing to consider labeling more broadly than for a very small subset of very sick patients, I might want more safety data to justify it. Basically, if the company wants to market the drug (via the combo application) to a patient population that is less gravely ill than the patients they were originally restricted to, then the FDA might reasonably want more assurance that the drug is safe to offer to patients who may have options.

Interesting approach.

Worst reason I could think of - since data could not have been evaluated and we have no notice of severe adverse effects - would be the FDA colluding with BP to delay development. I don't think that makes much sense, given that the new ask of 10 additional patients, with relaxed standards, appears to be pretty light. That would be a very ineffective way of achieving this assumed intent.

My assumption is that, as we know, the company applied for ODD and was denied because the patient population was deemed to be too broad. Then the company says "well hey, the patient population you're restricting us to for the combo phase III is TINY - if we don't get ODD based on population size, then we want consideration for broader labeling". And then the FDA needed additional patients - with relaxed standards - to justify that consideration.

This would have been a clear failure of communication between the company and the FDA (responsibility on the company...) in the original negotiation of protocol. Another example of sins of the past that Tony is now fixing. Since Nader is still on board, you don't want to publicly throw him under the bus when the outcome is (hopefully) a short delay and consideration for broader labeling.

All pure speculation of course, but to me, it fits fact and incentive patterns pretty well.

Actually, it was the opposite. The rationale was that 30 would give statistical significance, but not clinical significance. That's a BS answer, because they would/should have known the number they (FDA) would need up front for either. Something changed in the ask - from one side or the other - in my opinion.

And again, the data was still blinded, so there's no way that the FDA looked at the data and decided they needed more.

I think it's important to remember that the data was still blinded - even the FDA couldn't see the data on 10/12. This line of reasoning is off base at face value.

Now, why the FDA required additional patients is still an interesting question. I have a completely unsubstantiated theory based on the rejected ODD application, but it has nothing to do with data.

Great question, and one I certainly don't have the answer for. Could be that they're not fielding serious BO conversations right now for one reason or another. Could be they only decided to drop the info on partnership talks to leave breadcrumbs for shareholders on potential strategies. Could be that BO talks are gagged by NDA's for both sides, as CYDY talking openly about BO might put a negotiating partner at a competitive disadvantage they wouldn't agree to, etc. All completely hypothetical.

As I've heard several times lately regarding this investment, I'm just ready to see the end of this movie. Hopefully the plot picks up soon.

Certainly can't dispute the historical batting average, but it's worth noting that at least one of these milestones (interim data) is nearly completely within the company's control at this point. If they miss that one without explanation, it's on them. Most (all?) previous timeline misses that I can think of involve enrolling patients in trials, which is very much not in the company's complete control. This isn't to excuse past misses - those misses show excessive optimism, lack of foresight or understanding, or some combination thereof. I'm just suggesting a way that at least one of these timelines significantly differs from past timelines, so one may reasonably expect a different result.

As for completing the enrollment of the last ten patients, I'm hopeful that they know something we don't, like that they've maintained a list of patients screened who would now fit the criteria. That could make the timeline accessible, and I would hope that they wouldn't put out such a near-term timeline without some certainty that they could hit it. However, as you've said, their batting average on things not completely in their control is not stellar, so I understand that pessimism.

I certainly hope they prove to be good points in a few weeks time...

I also forgot to mention the prospect of a GvHD partnership, as explicitly referenced on the CC. This is purely speculative, but it would be huge if they knew that something was in the works to be finalized in the next few weeks. Imagine this potential chain of events:

- Announce (assumed) successful interim primary endpoints, along with completed combo enrollment. That sets a time frame for top line results.

- Assuming some price action on successful interim data, R/S and uplist. You have full combo data coming to help combat any short pressure or gains taking.

- Once on a major exchange, announce a GvHD partnership with an established biotech company. If CYDY wasn't previously on analysts' and institutional investors' maps, it certainly would be then.

- Announce (assumed positive) combo results and an update on mono enrollment once you have analysts' attention.

Obviously this is highly speculative and contains assumptions, but I refuse to say that it's far-fetched. We've been given short-term time frames on interim and complete combo primary endpoint data, and we know they're in talks with potential GvHD partners. I think the assumptions can be supported by data that we've already seen. If they could align events like that and the noted assumptions hold true... look out above.

And if anyone is concerned about whether or not management is thinking this strategically, you have my permission to forward them a link to this post. I'd be happy for them to borrow as they see fit!

I agree completely, which is why they would only have to "delay" looking at interim results by 2-3 weeks (using previous expected data scrub time frames) in order to put those events so close. I didn't think the 10 patients was a big deal at all, and I agree that it might even be a long-run positive in several ways.

The company clearly stated that they expected interim data in 4-6 weeks, and data from the complete trial (i.e. including the last 10 patients) in 6-8 weeks. Key word was, of course, "expect". But those are unequivocally the time frames stated during the CC.

Regarding the timing of the interim data being 4-6 weeks instead of the 2-3 that it is assumed would be needed to lock, scrub, and present, it has always been my assumption that they want to be able to provide a positive update on final enrollment at the same time as the interim data or very near to it. Locking in a time frame for expected full top line results (more concrete than the 6-8 weeks given on the CC) would, in my opinion, generate a lot of momentum if presented in lockstep with good interim data on 80% of the trial population. Who's going to sell on the (expected) pop from (expected) positive interim data if they know that final data is expected 2-3 weeks later? That's pretty good short-proofing if they chose that time to R/S and uplist, as well.

Had they locked the data immediately after the FDA talk, they would potentially, even likely, had a gap of several weeks with interim data out but no news on enrollment or complete data. Just because they COULD lock it on 10/12 doesn't mean they WOULD. On the other hand, if they locked the data and had it in hand, they'd likely be obligated to release it publicly regardless of where they sat on enrolling the last 10.

That's a great web page pinky, thanks for sharing. I'm not sure where you got the "33% patient success" figure to move past phase 1 however - P1 is almost exclusively to monitor for safety and try varying dosages to test tolerance. Efficacy is monitored, but it's rarely, if ever, a primary endpoint in P1. The P1 for Prolanta does not have efficacy as a primary endpoint, although it is noted that it would be considered a secondary endpoint, as seen in the official trial protocol listed on clinicaltrials.gov:

https://clinicaltrials.gov/ct2/show/NCT02534922?term=prolanta&rank=1

Also, it's worth noting that the ~70% that make it to P2 once in P1 is likely an overall figure. There are more dissected numbers - which I believe have been previously provided on this board by a very bored lawyer - which show higher pass rates for ODD drugs at each phase, including for BLA approval. A quick search gave me this link/article, although I know there's a more detailed deck somewhere:

http://www.raredr.com/news/orphan-approval

It's a significant difference at each stage for "rare diseases" (ODD), and the cumulative difference is very significant. For the time frame studied, around 25% of ODD drugs that enter the clinical stage made it all the way through approval, compared to around 10% or less for all drugs.

Care to elaborate?

Thanks again, someconcerns. I truly appreciate you taking the time to respond in such an in depth manner.

I agree, and it's the only way that a R/S would make sense. It wouldn't be an act of desperation, but an act of opportunity. If management undertakes the R/S without the powder, as you put it, I think we'd all be in trouble. I can't entertain that as a realistic possibility though, because it would be akin to corporate suicide. I have to think management is as aware of that as the rest of us!

Hi someconcerns, really appreciate the response. Nice to hear from someone who has actually spoken with management, etc. Would it be possible to provide any color on the share restrictions you spoke of? I've scanned some of the filings since my first post and got the gist of the restricted shares, but my limited understanding made it sound like as long as BIVI is on the OTC, those shares are exceedingly tough to sell publicly. Any thoughts on that, or more broadly, what catalysts could or would unlock more of those shares for public sale?

Again, truly appreciate the response. Thanks!

You've got it now. Functionally no different from the authority they've been granted at the last several annual shareholder meetings. They have a range of dates and a range of ratios, and they're not bound to do anything.

I think they've waited on this authorization before proceeding with any interim data analysis. If I were them, I wouldn't want to have the interim data in hand, with a likely imperative to disclose to the market, without having my full toolkit in order. I think we see something on interim data within three weeks now.

I think you know this, but to be clear for others who may scan the board, this is just the SEC filing stating that the proposal to authorize a reverse split passed as expected. No reverse split has been effected as of yet, this just gives the board the authority to do it.

Thanks for posting that, tonecee.

Would you care to elaborate on your statement that "they are being strapped and raped by the large BP's"? I'm interested in what you know here, and even more so what you can provide to back up that assertion.

Precisely. There's a difference between a failing company throwing a Hail Mary to stay listed and a company with legitimate future prospects attempting to open up it's shares to a broader investing environment. Granted, the former is far more common than the latter, which probably leads to people conflating the two in terms of SP reaction. But if the future rests on the results of the trials, and the results of the trials are good (obvious presumption here...), then there's nothing to fear from a R/S.

Who's going to short a company releasing slam dunk P3 data (again, optimistic presumption) just because they uplisted via R/S? I'll allow that my belief in this scenario does hinge on management appropriately messaging results, following through with additional PR (mono updates, GvHD updates, etc). I can understand if some here don't feel like they can trust management to do that.

I know you didn't address this post to me, but...

Why would you need an exit strategy just because a R/S is approved? Because it will be approved. Just like it has been a shareholder-approved option for the board for the last several years.

Success or failure of the company - and therefore the stock price - is dependent on trial results and the ability of management to effectively message and leverage those results. Not an accounting move which, if properly applied, could open up this investment to institutional investors and a broader array of retail investors.

I don't understand everyone on this board, and others, that think that a R/S is a death sentence for a company with legitimate future prospects. I guess I shouldn't insinuate that you believe this, but your question about an exit strategy certainly begs that belief.

That's good work right there...

As I'm sure you know, T trades are actually trades that occurred and were processed during the trading day, but not reported until after the bell. Market makers have some latitude in when and why they choose to employ T trades in the name of market function...

To me, it looks like someone didn't want to report a buy that would have equaled ~30% of the total buys on the day... at least when the trade occurred. It's also pretty coincidental that the last trade of the day and the T trade were the same block size (150k).

Looks to me like a MM naked shorted a block to retail at .055, but didn't report that trade until after they covered their short on a last minute trade.

Can't wait to be in a more liquid market and off the OTC with this one. One day...

Thanks for the response, much appreciated. That does seem like an unnecessarily long time frame, but I realize it's just one possibility. I wonder if there might be a cardiology conference in a closer time frame? Or the annual JP Morgan biotech conference in (I believe) January... that might be solid, if less perfectly geared towards electroceuticals.

Just speculation here though. Sounds like you asked the horse, and from the horse's mouth came "mums the word."

One bit of the recent PR has gotten very little attention on this board:

"We plan to submit our preclinical post-MI remodeling results during 2018 for presentation at a relevant scientific meeting as we continue to advance our class-leading non-invasive electroceuticals toward the clinic."

Anyone have any thoughts or ideas as to what conferences or meetings may be coming in 1Q18 that could fit the bill? Does Endonovo have anything publicly scheduled? Seems that even early 1Q would provide time for peer review of detailed data, which could be beneficial.

Despite the bizarre headline, some positive press on CYDY from Seeking Alpha:

https://seekingalpha.com/article/4115173-cytodyn-dresses-hiv-patients-ccr5-halloween-mask

I would argue that the slate of known side effects that come along with current standard of care mean that the HIV population could be much better served by a new and different option. Pro-140's safety profile is a big positive in this case. If being pretty effective without destroying your liver, kidneys, heart, and other vital organs isn't important then sure... the HIV community is already pretty well-served. Personally, I think that's an extremely strong argument for not requiring a second phase III trial. Your opinion may vary, but that prospect doesn't worry me a bit. If the drug shows efficacy and nothing changes in the safety profile, I don't believe there's any way the FDA would require a second P3.

Also, you keep mentioning resistance, but there has never been a documented case of resistance related to Pro-140. Resistance is defined by the presence of antibodies to the drug itself. Rebounding, as occurred in some P2 patients, is not the same as resistance. That doesn't mean that the rebounds (which aren't discussed much these days...) aren't important - they're very important - but there's literally zero evidence to date of patients developing clinical resistance to Pro-140. And it's not just semantics, there is a functional difference.

I agree, I think we're set in the long term. Day to day trading on early stage OTC biotechs really just isn't a reliable indicator of potential value. If their technology works, even just moderately, this is little more than the tip of the iceberg. If the FDA wants to work with them (again I ask - does ANYONE have insight into that SRO designation??), then things could happen very quickly, relatively speaking. If and when things like the device being approved for one, or multiple, indications happen, these daily fluctuations and price mysteries will be little more than historical anomalies that encouraged some folks to buy dips at a very, very low price per share.

That said, I'd love it if they had more news to follow up with. The data in the deck, while convincing to my untrained eye, was pretty sparse on detail. I appreciated it, but at the same time definitely wanted more. I'm also slightly disappointed that they don't intend to present to any conferences until 2018, but that's likely just a logistical issue.

You could start by saying that your previous comment was either uninformed or intentionally misleading. Your pick.