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I'll second that - greatly appreciate you passing along what you heard.
Appreciate the responses, thanks sello!
Appreciate the info, sello. Has ENDV produced any investor relations materials beyond the PR's on the website? Thanks again.
Hi all, could anyone point me to any PR or documentation on the pre-clinical trials they're currently working on? Thanks in advance.
Lots of excitement around here, have to find out what this is about...
I'm beginning to think that he doesn't even understand the game that he thinks he's playing...
Makes sense. I misinterpreted your initial comment.
5top, have they filed for confidential treatment before any of the prior raises? Honest question, but I don't see where they have. Suggests to me something different, for better or worse.
I would think that if what they were requesting confidentiality for was regarding an equity offering, that would likely be denied confidentiality. But I'm way out of my league here and definitely just going the deductive route. Interested to hear what experience others may have with these filings - seems like they're relatively rare based on the numbers gestalt posted. I gave that paper a quick skim, but it's too dense statistically for me to parse much in five minutes...
Hey Amateur, I think that I actually did address that point from Pearsby. HAART is very effective, generally, at viral suppression. As misiu also alluded to, it's very terrible at providing quality of life. "Puke or die", as Pearsby likes to say, is only a palatable option if there are no "don't puke, don't die" options. The combo trial is necessarily focused on the salvage market, which is slowing enrollment of course and makes the market look tiny, but the actual market for a better therapy is much larger. Also, I would disagree that the mono therapy is not efficacious enough to draw BP attention. Even if 40% of newly-infected, CCR5 only patients rebound - and that's not allowing for the possibility of addressing that problem along the way somewhere - there has been no indication that it creates a problem moving to HAART after taking PRO 140. That would make it the logical first choice of treatment for a new patient, and there is significant evidence, albeit from a small sample size, that it can work as a longer term monotherapy treatment. Basically, I'd argue that the second half of that quoted statement is completely unfounded.
...it was a joke. I suppose I need to work on my delivery.
There was nothing funny about my bid not clearing, however.
Depends on when you put in your bid. Was it before I put my bid in at .515? Logical, in that case. If it was after I put in my bid, and you kept it from clearing? That's clearly an emotional, mean-spirited trade and you should be ashamed of yourself.
Good question. Patent protection extends 20 years from date of application filing. I believe this is the correct patent: filed 11/24/2010, granted 9/2/2014. Coverage til 2030 isn't bad when you consider the patents the big players have rolling off in the next 2-3 years...
http://patents.justia.com/patent/8821877
Full list of Cytodyn patent applications:
http://patents.justia.com/assignee/cytodyn-inc
Fair points, Fred. See how that's done, Pearsby?
First, you're completely correct about a partnership being inherently dilutive, and I could have worded that more carefully. I think most would argue that it would have likely have significant advantages over current methods of financing, not the least of which would be some measure of certainty. A clear picture on the funding front should help produce more accurate valuations, which I'd argue would be beneficial in several ways. But no doubt, a partnership would be dilutive to value.
I think you're generally correct on combo vs. mono. To your point though, by the time combo is theoretically up for BLA, they'll have no less than 1/3 of the data from the mono study out of necessity. If early returns on the first 100 patients are good, most would reason that little would change for the remainder of the trial. I think some sort of deal is likely at that point assuming good data, because I agree with you that if they can complete the trials, approval would be unsurprising.
Also true about costs - to a degree. Only $33 million was trial costs. The rest was for CMC costs. And you're correct that he mentioned additional SG&A as well, though I'd argue the $60 million number is the bulk. There may be additional costs there - it might even be likely - but those are the numbers straight from the horse's mouth 24 hours ago.
I think the road there could be very painful to shareholders, or it could be rewarding quite quickly by meeting enrollment targets, getting the results, and partnering. Not sure which is more likely to be honest, but at least we're talking about actual facts now! And personally, I think it will get there one way or the other, and even if painfully diluted, will provide some return to shareholders. The potential upside should be significantly better than "some upside", I would think.
Good post, appreciate it.
Chump, I probably could have saved myself a few minutes on that reply I just posted if I'd simply waited for yours.
Below is the (actual) reality:
- CCR5 only...with significant rebound/resistance
This is true. Partially. Rebound and resistance are NOT the same thing and cannot be used interchangeably in meaningful medical discussion. There has been zero resistance noted to date, marked by the presence of antibodies to the treatment, which is very significant in HIV treatment. I'm sure most of us would have liked to have a better discussion around the rebounds yesterday though, as that is certainly a lingering question.
- Multiple Dilutions awaiting in the wings...we all know that!
We don't know that. What we know is that the company projects a funding need of $60 million, over two years, to complete the four trials currently planned or underway, as well as CNC activity. True, dilutive funding is likely at some level, but a partnership would significantly reduce the specter of dilutive funding in the future. As would share price increases from hitting primary endpoints, etc.
- GvHD and other non HIV related data..years out..we also all know that!
Actually, the FDA-approved phase 2 trial for GvHD is expected to begin this quarter, and is expected to take 6-9 months as explicitly stated by Burger yesterday. It's not tomorrow, but it's not years out either. If you don't believe the timelines, that's fine, but don't spread lies.
- Our new commander, is still not a BP CEO, CSO or acquirer with history..None!
Is that really what you expect? A BP CEO to come lead a developmental drug company with a market cap of less than his or her net worth? I think that having Caracciolo, who has significant executive-level experience in BP in operations and other areas, is more than adequate. Particularly since his primary experience has been with HIV treatments.
- Delay after delay, showing slow adoption of the SC Me too Haart regimen...30 patients world wide mind you!
The delays are not what anyone wanted, obviously. They did give significant reasoning for why adjunct enrollment was proving difficult, which is probably why the FDA reduced N from 300 to 30 even without BTD. The standards simply make it difficult. They're also not recruiting patients worldwide, so once again, do not lie. I'd be more encouraged by the fact that they expect to be able to fill 100 mono patients by the end of 2Q. Also, it's HAART, not Haart. It's an acronym, and you'd surprise me if you could give the long hand version without googling it.
- No GvHD significant update per CC. Autoimmune a dreamland back up for HIV failure.
I'd say the fact that they had wrapped up another animal study and presented the data to the FDA, who then approved protocol for a phase 2 human trial, is a very significant update. Your perspective may differ.
- Everyone is excited about the new CEO, but we still have the same data Jam! Just another PhD, trying to lend credibility to the slow accruing data set.
True, still a data jam. But Caracciolo isn't trying to lend credibility to a slowly accumulating data set, he's setting realistic expectations for the timelines of that data. That's a big difference, whether you acknowledge it or not. Also, he's not a PhD. Why do you just say random things?
- 3 to 4 month delay = Huge Dilution. The 5 to 10 dollar dream, has been diminished to 1 to 1.50 BO at Best!
I've already addressed the dilution aspect. I also suspect that many investors would be happy with the 2-3x return that you mention, without any supporting analysis, as the new best case scenario. You talk about a 200% return like it's a failure. Odd.
- PRO 140 is a ME TOO MOA SC delivery of HAART. AND..HAART is 96% effective..Puke or Die!
This is erroneous on so many levels that I'll only address two. First, PRO 140 is not HAART, which I'm pleased to see that you correctly capitalized this time. That's kind of a crucial difference - we can discuss it at length some other time if necessary. Second, HAART is 96% effective in the narrow perspective of suppressing viral load, but it's very ineffective in providing a high quality of life. "Puke or die", as you ever so eloquently put it, is only an attractive treatment option if there is no "don't puke, don't die" option. PRO 140 is intended to be that option.
- For those that think I am a basher...look at the pps pattern over the last several months....this is called reality...not manipulation! Now go ahead and spin, spin, spin..and not reconcile all the miscalculations. Hope I am Wrong. Pathetic and Sad! Quarters late..not days or weeks! Total incompetence, then to leave the drain on the cash burn by letting Dr.P sift from our investments. The BOD is also worthless and not concerned with Shareholder value.
The reality is actually what I just stated in rebuttal to all of your partly or completely unsubstantiated claims. I'll just note again that your excessive use of "pathetic and sad!" is eerily reminiscent of Donald Trump's tweeting, and I'm not insinuating that your communication style is presidential.
None of what I wrote above makes a surefire claim that CYDY is a solid investment opportunity. It may be, it may not be. I don't know. What I do know is that nobody on this board objects to rationale discourse and reasonable questioning of the characteristics of an investment or a company... but nobody likes a liar. That goes doubly for a liar with an agenda. So at least try to keep the facts straight.
Yeah, he's definitely been a pro. That comment from the investor was rough though...
Seriously though, is nobody going to ask directly "how many do you have enrolled in adjunct RIGHT NOW?"
That was a brutal backhanded burn. LM is a good guess - could have been about 20 others on this board though.
And there it is. AC is running the show. That's good anyways, it would seem.
I'd agree that Pourhassan is clearly second fiddle on this call. Not sure I'm as optimistic on the financing as you are in the near term.
Seriously? Not going to even give real time enrollment numbers? Someone better grill them on that in the Q&A.
Smoke 'em if you got 'em boys...
Did notice they introduced Caracciolo before Pourhassan.
I would think that that's an equally likely situation, and even as a quite new investor here I definitely empathize with your situation. Hopefully we get good news on the CC and all of the speculation turns out to be needless.
Although admittedly uninformed on the matter, I would think any existing warrants would vest immediately.
Continuing with the positive spin, maybe the Paulson meeting has nothing to do with another raise, and is actually a meeting of the new millionaires' club. Though I'm not expecting that by any means, a gathering like that wouldn't surprise me totally on the heels of very, very good news. If I were Paulson and one of my investments came through that I'd sold, I'd certainly treat folks to a few free drinks and a piece of cheese!
Morton's?? Now you're just rubbing it in.
Interesting that it's the first one in ~3 years at least. Thanks for the information. I'd be highly interested in any speculation or information you lucky, well-fed invitees might have regarding potential topics for discussion.
Yeah... I'm hoping that "Q2" means "last week". Time will tell.
This Paulson meeting on the heels of the scheduled CC is definitely giving me some pause.
I'm not saying that you're short or not...
But if I truly believed every one of those things with the certainty that you purport to believe them with, I would be very, very short.
Dangers around every corner...
Very interesting, truly appreciate the responses.
And never look a gift drink in the mouth. Two free beers is better than none!
Thanks for the response Dog. Now I'm more upset that folks are getting free drinks and apps than the prospect of more dilution, but that's probably just because I haven't had lunch yet.
Have these Paulson meetings been frequent/regular in the last two years? And have they frequently coincided with opportunities to participate in additional raises?
BioTechG and Dog... can you comment on the timing of previous "invites" from Paulson and subsequent raises that were executed?
You're a smarter man than I, Chump. But damn I do love my bourbon. And my gin. And my rum...
Gladly. Though Chump strikes me as a gin man.
Luckily, I'm relatively well-supplied for most eventualities in that regard.
Mountain Time here, so you don't have me by much... Just saying.
All that I know for sure is that there will be a nice pour of bourbon accompanying me to that conference call. Appropriate for any outcome, and one should be prepared for anything.
Thanks, and agreed. The last two raises clearly indicated where management thought they were - very close. Otherwise, you take your medicine all at once by raising the cash that you realize you need. I hope to see evidence supporting that optimism in the CC.
My personal hope is that they missed (speculation based on the timelines in the deck) adjunct enrollment timelines because they chose to focus on mono enrollment, realizing that strong safety data from mono is needed anyway and would be excellent piggyback news to go with adjunct enrollment or endpoints. Otherwise, you have (presumably) solid adjunct data, and then have to wait months at a minimum to really go forward while you wait for safety data. That would seem weak strategically, when the stock clearly needs strong, and likely fast, price appreciation to get off of the OTC.
Strong mono enrollment numbers and strong progress on adjunct would be a great combo, and I believe that it would make for a very nice Wednesday morning next week. That said, I'm similarly bracing myself to hear more of the same. Time will tell.
Agreed 100%. If you're actually long, the delays and SP volatility are nothing. Also agree that missing timelines, etc, is not unique to CYDY. All the same, I prefer delivery on stated expectations/hopes/promises as opposed to lack of delivery. It just doesn't look good on management, especially if it becomes a pattern. I'm hoping they learned a lesson and will set tempered expectations going forward, which the recent investor deck appeared to do.
But then again, I'm truly long, and it's based on the science instead of the management. So it'll work itself out just fine.
Yeah, let's not split hairs here. I'm long and very bullish on CYDY, but semantic arguments to defend Pourhassen's over-promising and under-delivering for the "Golden Quarter" don't seem productive or helpful. You can call it a promise or a hope, it doesn't really matter to me. The company under-performed last quarter relative to expectations set by the CEO himself, and that's the bottom line.
Hope that the CC holds some positive news.
Pearsby is not all wrong about everything. And when his or her thoughts are presented for conversation instead of COLD HARD FACT THAT EVERYONE SHOULD KNOW BY NOW. SAD!... then they can actually be discussed in such a way that can add value. That's not a terrible thing. And it's why I haven't blocked Pearsby, despite the Donald Trump-like phrasing and use of all caps.
However, the posts are starting to remind me of the comments that you see on every news article. You know, the ones about how I now work from home and make $7,000 a month? Those posts. Because they never change. There's no new opinion, or fact, or angle that's being brought to the board.
And that, Cynmark, is why I think you and others are right about Pearsby's intentions here. There's no actual conversation there anymore - just canned statements designed to stir the pot. And always stirred in one direction.
Interesting analysis trding, appreciate you passing it along. I tend to agree with you that the recent SP action is likely minimally impacted by tax season and is mostly due to stronger currents of doubt around timelines, management, dilution, etc. But, as d0lphintom and others have noted, there's at least anecdotally some evidence that tax season has impacted CYDY a bit.
And you're right, the CC is vital to near-term SP action going forward. Let's hope we hear something positive and we've already hit the final bottom.
It's been mentioned several times that everyone realizes that people are not selling to take a tax write off for 2016. The speculation is that people have to pay taxes next week, and they need actual cash to do that, therefore there MAY be some selling as people liquidate holdings to pay taxes. Individuals may have different strategies on locking in losses or gains at this point in the year depending on their individual circumstances.