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Great, thank you!
I can't watch today - mind reporting back with anything interesting? Thanks in advance.
Again, that data is from early March at the very latest. They should be presenting up-to-date data on Saturday.
And you'll recall that of the 8 that had completed the study, 7 were on compassionate use rollover. You don't keep taking a drug that doesn't work. The data will be fine, it's all about updated enrollment numbers at the moment.
My pleasure. Just trying to keep the information straight and keep everyone's heads straight as well. Helping those who've helped me, all that good stuff. I'd hate if that block that sold at .56 sold because they misread or misunderstood information that could have been cleared up.
But I hate even more that it didn't dip to my junk bid at .55!
We've discussed this before. The abstract on the website is the one that they had to submit to ASM months ago in order to (eventually) be accepted to present. Working out the timelines from the ASM website on abstract submissions - some of the dates had been removed by the time I tried to back into it a few weeks back - showed that the abstract was probably written no later than late February or early March. Everyone chill.
My understanding is that they'll be presenting interim results, which I take to be more thorough and up to date than the abstract written 2-3 months ago. However, as others have noted, unless enrollment was completed well over a week ago, the primary endpoint data for the one-week double blind segment of the trial will still be blinded. Results from the 24-week open arm segment should be available in real time, which is what I'm hoping to hear about.
If anyone needs more information on the structure of the trial, please refer to www.clinicaltrials.gov. I posted the exact link to CYDY's trials earlier today.
Thanks BH, good link. I'd also suggest this link for additional technical information.
https://clinicaltrials.gov/ct2/results?term=cytodyn&Search=Search
Can't disagree, that would be a big disappointment. Not saying I'd sell and leave, but I'd be considering options to lower my average at that point.
Can't help but think that this is tied in with the financing as well. Positive SP movement on no news when everyone knows that funds are needed makes me think that the raise is on better terms than expected based on positive news to be released at this presentation on Saturday. I'm not privy to any information, but I can see how slow dissemination of that information could move the support level from .50 to .60 in a week in the face of a funding need. Gives me more hope that we'll see news/enrollment on the positive side of my over/under.
That's exactly right. A company doesn't submit an abstract to present interim data that is showing an ineffective drug. It's one thing to question management... but they're not self-destructive. So the data will be good, and the only thing that matters to us as investors (instead of scientists or doctors, with apologies to misiu) is the enrollment. I'm putting the over/under at 20, if they're over 25 I'd be thrilled.
Appreciate your due diligence and willingness to share. Sounds like all is as expected. It will (making some supposition here, of course) be interesting to see how the FDA handles labeling and how the insurance companies handle it. However, I don't expect CytoDyn will be dealing with either of those issues, if you get my drift.
Appreciate you sending the email, I've wondered about the trial protocol as well. Perhaps they thought that it would be a more direct indication of efficacy without properly considering issues with enrollment? Who knows.
It may be worth remembering that while the trial is for patients failing (I believe...) 3 classes of drugs, the proposed indication may not be that limited. E.g. if a patient is failing one class of drug, they could go on PRO 140 in combo once approved. This would likely expand the market significantly. Otherwise, I'd say Fred's comments are spot on.
Fred, anything you can add about a potential raise through Opus?
Agreed.
If anyone wants to see what pumping looks like, please check out the ENDV board. You'll quickly realize that what you see on CYDY is not pumping.
Appreciate you following up, broker57. Please keep us posted on anything you hear!
Wish I knew. Broker57 was the one who brought it up, I'm just as clueless as the rest of us!
Ha, yep... no doubt about that.
Interesting, thanks for sharing. I value anonymous online advice at roughly the price I pay for it, but that view seems to align with talk of another round of funding. I'll be interested to see the terms of new funding. That's the big question for me at the moment, along with wondering how much dilution is currently priced in.
It is very, very quiet here.
Who's saying to sell on the next pop? Haven't seen that here.
Anyone in the know have an update on the capital raise?
Many thanks, BH.
It's true that I really shouldn't dignify those posts with responses, but we had a Derby party yesterday and there were pitchers of mint juleps so...
Pretty much fair points. However, I have no doubt whatsoever that they'll be able to get the money to finish trials. That's never crossed my mind. The terms of that money is a completely different story, and disadvantaged terms could be very harmful to shareholders of course.
I don't think that they'll need the money to finish trials, because my opinion is that this is too disruptive of a drug for the handful of BP's that run HIV treatment to allow to market from some upstart company. I believe that's why they raised funds piecemeal, and are itching to get the adjunct finished and the safety data from mono, because they know someone will partner or buy at that point. After that, you've demonstrated efficacy and safety, the FDA appears to like the drug... you're just going to let some one-drug wonder with a current $100mm market cap come drink your milkshake for the next 15 years? I don't believe that because I don't believe that's the way the business world works. After success in adjunct and demonstrated safety in mono, the questions remaining for me are:
1) when?
2) who?
3) how much?
#2 doesn't matter much to me other than the fact that there are likely to be several interested parties. As for #1 and #3, the more mono data is present, the higher the price tag is going to be for an acquirer due to lowered perceived risk of the drug not being approved. You're going to have several BP's playing chicken to see who thinks that they can wait for the most data to guarantee success, but knowing all the while that several others have the cash to make this a payday for the company while still acquiring for relatively cheap.
In short... I believe they'll get money to finish up what they're doing with no problems. More delays mean worse terms for that money, which would really hurt SP. I expect a buyout after adjunct completion (latest efficacy and safety data from that obviously looks good) and mono safety data, because then the company has all that they'll need to apply for BLA.
I agree with you that mono enrollment shouldn't be hindering adjunct, except in the sense that they may have limited resources to push the centers, and may have to choose where to focus.
Pretty much nails it, in my opinion. Although a D+ on the current SP may be generous.
I can't really disagree with you there. I'm hopeful that the management team now has the right people in the right roles, and can be a little more focused and efficient towards meeting stated timelines. That said, if I have to wait til Labor Day for that news, that's fine too. I'd obviously prefer sooner, but I'm confident of the ultimate outcome.
Agree completely that mono is the game changer. Definitely looking forward to updates on both trials though.
Caracciolo did mention end of Q2 as the stated timeline for 100 patients enrolled in mono, and talked like that one was much simpler than combo. I don't know if they'll bring it up at ASM (it's very early in June, don't forget) but I'm hopeful for a call or PR near the end of June. Even if they miss that timeline by a little bit, I'd say things are going quite well at the moment from the little bit of recent info that we have. I'm comfortable.
I'm hopeful that the numbers that they present at ASM will reflect updated enrollment for May, but the numbers that we're talking about from the abstract cannot be current by definition. The abstract had to be submitted no later than sometime in March. There's no way those numbers could reflect current enrollment.
You may have been saying the same thing, but I just wanted to be clear.
It's important to remember when the deadline or these abstracts occurred when you're judging the enrollment rate:
https://www.asm.org/index.php/abstracts-microbe-2017
The WITHDRAWAL deadline for the LATE-BREAKING abstract submissions was over a month ago. Which means that, even though the actual submission deadline dates simply say "closed" right now, you can safely assume (also based on when the emails were supposed to go out for late breakers, which was late March...) that these numbers are from no later than early March. These numbers are at least two months old, possibly a little older.
So, while we'd all like for the N to be higher, let's remember that these numbers are necessarily quite dated, as pointed out by someone here already. Not much new from what we already knew in terms of enrollment, but all 8 that completed the 24-week open label arm were showing essentially zero viral load, and 7 carried on to rollover? We knew about the rollover, but not (to my knowledge) that all that finished the trial (excluding tropism issues who dropped out, of course) showed effectively zero viral load at 24 weeks. And again, these were patients whose current treatment regiments were failing them. What this says to me (my opinion) is that the efficacy portion of this is open and shut, it's simply a matter of finishing enrollment. That sort of interim data should hopefully be helpful with recruiting funding on much better terms as well, because it should reduce failure risk in theory.
And to the poster who said that they only really cared about mono... fair. That's where the zip code changing money is. But we've heard lately from GILD that they're interested in acquiring drugs, including in the salvage HIV market, and that they're interested in novel treatments with long patent lives. Their words, I can dig up the transcript if needed. Adjunct is a great insurance policy at a bare minimum because someone will be interested at some price, and I'm damn happy to see positive interim data.
Plus, it's life changing for very ill people. So that's nice too!
I haven't seen those results before either, pretty sure that's updated from any previous releases. While we'd all love to see the N higher at this point, we don't know exactly when the data points were taken for this abstract, and the endpoint results are (unsurprisingly) impressive. And while the slow enrollment has been annoying, what's kept me up at night (so to speak) is the possibility that the data doesn't come back as strong as expected once the enrollment is complete. This data appears to be as strong as expected, maybe better.
That's good enough for me to sit back and average down.
The problem with ignoring the posts is that others who may be newer to the board may take them as informed posts. At the end of the day, I suppose that doesn't affect me personally too much with this particular investment, but I suppose I'm a stickler for integrity. A personal shortcoming...
As for your scenario, I think it makes as much sense as anything. However, I'm sure that given some free time, we could draw up a few more scenarios that fit the data points but have different outcomes. That's why I keep going back to the data from trials at the end of the day. All that I know is that the data I've seen from previous trials supports the conclusion that this will be a successful product in the future. From there, I believe (opinion based on some financial analysis) that it will be worth more in the future than I've currently paid, regardless of the potential for reasonably painful dilution. Until I hear otherwise on the science/results, I'll be sticking around and maybe averaging down some. I'm sure you can make some money playing the flipping game here, but that's just not my style when dealing with binary outcome events of uncertain timing. To each their own on that one.
That's interesting indeed. Appreciate both of you providing info from that call.
I'm interested in what you have to say here - what experience do you have that would suggest otherwise? It is my understanding that most infections begin as CCR5 only, and over time will likely mutate to CCR4 as well. I may be misinformed, and I would love to know if so. If the viral load is completely suppressed from early on, however, there can be no mutation to CCR4 affinity because there is no viral load to mutate. Just like I can't drive a car that I don't have, no object can do anything if it doesn't exist. If it is less than completely suppressed (but still within generally accepted limits of efficacy for HIV treatment), mutation would (likely) happen much more slowly. Here I admit that this last statement is based solely on deductive reasoning and my understanding of biological mutation mechanisms. There is evidence from trials to support the assertion that for some CCR5 patients, PRO 140 can completely or nearly completely suppress viral load for an extended period of time, without any adverse effects noted to date. There is also no evidence that patients who have taken PRO 140 develop any resistance to HAART. So here's the question...
If the worst case scenario is that the drug is only effective enough to suppress viral load for a period of years prior to needing additional therapy once the virus goes CCR4 (and again, this is what I believe is an absolute worst case scenario based on the data that we've received to date), why would the FDA not approve this drug, and why would every single new HIV patient (and many existing) not want to use it for as long as possible? You consistently play down the side effects of HAART, but it's not just nausea. You consistently leave out the toxicity to various vital organs, statistically (significantly) increased risk of death due to kidney failure or heart attack, etc. These are not trivial elements. Literally anyone in their right mind would prefer this (based on what we currently know) to HAART. Even if it worked really well for 10-15% of patients (which I believe is very low, again based on data we have), the FDA would be falling all over themselves (once efficacy/safety are demonstrated to their satisfaction) to approve it based on the lack of serious adverse effects and the ability to switch over to HAART if neeeded.
So, back to the question. What in your experience would suggest otherwise, based on the data that we have?
I don't kid about money. But damn, if I wanted to make jokes right now, I'd certainly have the material.
Your 35 years of experience in the health care field mean absolutely nothing to me if you think that a placebo can completely suppress HIV viral load for over two years in any number of patients. The only thing in any of your statements that I can agree with - and here I have to edit heavily - is "data... is all that matters."
That is correct. And the data has been good enough for the FDA to support mono trials thus far. And the data from the ongoing trials is the only thing that truly matters for shareholder value going forward. This is what happens to the price of companies that are in cash burn mode and have delays... It's not good. Nobody ever once said that it was good. But the data from the trials is all that matters.
Incredibly low volume... was interestingly low on a few other companies I'm in as well. Not sure what that is about?
Re: Pearsby, I'm glad you feel that I could address him/her appropriately. I'm consciously avoiding ascribing motive or intent, however. While I'm sure it exists, our mods specifically warned us against speculating on other posters' intentions, etc, so I'm trying to play nice.
I almost feel like we need a sticky on the board to warn newcomers about certain members of the board.
I'd like to point out that you seem to think that a placebo can - even in limited cases! - completely suppress HIV viral load for a period of years. If you'd preface all of your posts with that statement, I don't think anyone here would complain about your posts. It would be immediately obvious that your statements should be discounted completely.
Also, I like how you've thrown in yet another completely unsupported statement (3 years from now to reach N=300 for mono) while I'm criticizing your unsupported statements. I'm surprised that you even chose to respond to me. Usually you just ignore me and go offline for a day or two after I prove, yet again, that you make consistently make false and unsupported statements.
FYI JoeCanada, can't reply to PM's, but I'm glad you appreciated that.
Upon reflection, I agree that that's a likely scenario.
But isn't it funny to imagine someone stockpiling OTC holdings to trade for contraband in prison? Come on, that's a funny mental image. I couldn't just not use that once I thought of it.
Careful calling out obvious falsehoods and calling an ignorant person (or intentional liar) ignorant or a liar - you'll get your posts deleted.
Better when he stops buying. I imagine that the SEC may have something to say about constant Form 4's if the pre-clinicals are completed and there's finalized, non-public information available to management.
I love the confidence the president clearly has with the open market buys, but big news won't drop until after he stops. Unless he's saving up those shares to buy cigarettes in prison.
And I'll never argue with an up trend when I'm long...
None of it actually matters until news on the trials. It's clear to many here that the potential is there, but until then enough people will diddle around and flip for tenths of a penny to keep the price from moving but so much. No offense to the technicians (or the flippers, for that matter...) - I enjoy all of your posts because I learn a lot from them - but nobody is buying this stock based on Bollinger bands for the moment.
Really enjoyed all of the DD over the weekend. Nice collective work on that, board.
Now don't mind me, I'm going to go back to sitting on shares, eating popcorn, and waiting for news. Which is hopefully soon, because daddy needs a new vacation home.