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What's next? Deal or new raise that pushes this under .30?
Just a running gag between me and Fortuno, since NP says "any day now", "absolutely" and "great question" too often.
Ok, it must be ny end of December!
Great question!
Any day now ;)
I own a starter position at 1.50 and am heavily tempted to double down (while being aware that this could be a total loss).
Anyway, will be interesting to see how this unfolds, even if shareholders should be wiped out...
Yes, that's the question. Could be very very lucrative in this case...
Yes, the similiarities are striking: CYDY failed all its trials as well - oh wait...
Yes, he worked so hard that he got us zero patients with interim results in Q1 19.
Same on the German board; bcgk disappeared, Elementarteilchenzyklop posting on the sane tickers appeared; then Elementarteilchenzyklop disappeared and bcgk re-appeared
I'll gladly take both in either order ^^
IMO they won't PR safety/stability data and BLA submission separately.
Anyway, finish line seems to be very close. Hoping for NASH by end of this week and licensing agreement by end of this month.
Time for you to average down ^^
Another appetizer PR
CytoDyn's Lead Product Candidate Leronlimab (PRO 140) Inhibits Colon Carcinoma Metastases to Liver and Lung in Preclinical Studies
Download as PDFNovember 19, 2019 6:00am EST
CytoDyn will file for expanded access IND for patients with pancreatic, prostate, lung, breast, liver and melanoma cancers
VANCOUVER, Washington, Nov. 19, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that leronlimab inhibited a human colon carcinoma cell line, SW480 cells, metastases to liver and lung in a well-accepted mouse model. These human colon carcinoma cells were implanted in the colon walls of immunodeficient mice and treated with a control antibody or leronlimab. After four weeks, the mice were sacrificed and the lungs and livers removed for analysis of invasion of the colon cancer cells. Leronlimab produced statistically significant inhibition of metastases to lung and liver in this mouse model.
“This is additional preclinical data supporting the clinical programs that CytoDyn has underway in the oncology space,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. “We plan to take advantage of the recent FDA recommended Master Protocol design. Under the Master Protocol design option, we will use the Basket Trial alternative for single therapeutic agents with enrollment of different cancer histologic types when a single biomarker is identified. In our case, patients with metastatic disease of different histologic types, all expressing CCR5, will be enrolled,” concluded Dr. Pourhassan.
Bruce Patterson, M.D., Chief Executive Officer of IncellDX and science advisor to CytoDyn stated: “CytoDyn will file for expanded access IND for patients with pancreatic, prostate, lung, breast, liver or melanoma cancers because we have been able to detect immune cell infiltrates expressing CCR5 that could impair the immune response against the tumor if CCR5 is not blocked. Having the ability to detect and quantify these target cell infiltrates puts leronlimab squarely in the personalized immune-oncology arena with a mechanism of action common to many tumors.”
The U.S. Food and Drug Administration recently announced the availability of a draft guidance for industry entitled “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.” This guidance provides advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human (FIH) trials, intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. In contrast to traditional trial designs, where a single drug is tested in a single disease population in one clinical trial, master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple substudies, allowing for efficient and accelerated drug development. One example of the types of master protocol designs includes trials commonly referred to as basket trials.
A Basket Trial involves a single investigational drug or drug combination that is studied across multiple cancer populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. It is usually designed as a single-arm, activity-estimating trial with overall response rate as the primary endpoint. A strong response signal seen in a sub-study may allow for expansion to generate data that could potentially support a marketing approval.
CytoDyn has also recently been cleared by the FDA for a Phase 2 protocol to proceed for combination therapy of leronlimab and Regorafenib in patients with metastatic colorectal cancer (mCRC).
When will these clowns get to court?
You mean TheLawman?
Average volume and turnover for popular and growing mid-cap bios can be quite high (see e.g. Amarin with at at least 3-4m shares à 15-20$ traded per day).
500k shares at $10 = 5m wouldn't be that much I think. When it gets to $10 that presupposes big revenues in combo, positive cancer data, mono success etc. At that rate, 500k could be 10-20% of daily volume. Sure, if you throw them on the market without a limit at any price, SP will tank. But sold with a limit with partial fills, it might get through within a day. If not, several partial orders over a couple of days will surely do it.
When this gets more attention through a deal, BLA submission, more cancer results etc. and/or is uplisted daily average volume will increase at least tenfold, so selling larger positions won't be an issue.
Keep in mind: 1m volume×0.3 is still just an exchange worth $300k.
"Fruitful, enlightened discussions are the main reason most probably come here IMHO."
Good one, made my day!
Yes, that's all fine, but since it is just a small speculation in your portfolio you can afford to lose, why post things like "drops to .33, ridiculous"?
And that's still no explanation for buying more when you are 99.9% certain it will drop short-term since no deal next week as you suppose (you may very well be right with this btw, I'm totally convinced that NO has to deliver and prove himself, and that there is a at least 50% chance nothing will happen next week). You wouldn't get into an aircraft if you thought chances of a crash are 99.99%, right?
I guess you are only 75% or so certain, but since there is a small chance you hold and buy even more, don't you?
No. They had a board of cry babies who understood nothing of the science.
What is it now? I thought you were convinced that the science can't be that good, otherwise we wouldn't be at .30.
Could we please give him till 1 November please?
Yes, journalism comparable to that Spiegel guy Relotius ^^
EDITED 1 o>8
EDITED 2 abc
EDITED 3 :>8
I'm really curious how you view this investment then, especially since you bought more a couple of weeks ago.
If nothing get done and this is a scam, the SP will fall down rapidly, so why buy more at this point if it is a sure thing that you will be able to buy at .10 or so soon.
Apropos:
"I have received quite an overwhelming response of new viewers on my new blog post across the world."
We will see. Yes, might get very painful. At this point, I'm not overly optimistic. But I won't sell.
I don't understand why you bought more a couple of weeks ago, if you have so many doubts and think it'll go to .15.
Doubt must make a difference in practice, if not, it's not a real doubt.
"120. But if anyone were to doubt it, how would his doubt come out in practice? And couldn’t we peacefully leave him to doubt it, since it makes no difference at all?"
The SP is likely to head south further until the deal. Wouldn't surprise me. Yet posting "Down again" "What a OTC POS!" every day won't change it.
We simply need to see what they deliver by 1 November. If that deal should fall through, though, yes, we might see low 20's or high 10's.
The main problem is that Nader talks too much and gives too optimistic timelines. And I don't understand some strategic decisions of the past like delaying GvHD, not raising a big chunk at once to avoid a slow bleeding etc., that offer for "loyal shareholders", prognostic test, not outlicensing certain territories...
A lot of the delay is on the FDA who insists on more and more data for a immensely efficacious and safe product for patients with very limited treatment options...
Considering all the facts, even in a worst case scenario with 1b or 2b shares, it should be worth much more than .30 or $1, although SP would suffer a lot mid-term. So, yes, from this perspective, IMO CYDY is derisked, but of course not totally derisked, if the FDA should demand further data (which at this point seems rather unlikely though). All the clinical data seem excellent too; manufacturing portion is in the hand of Samsung. Risk of a CRL after BLA submission is very low IMO.
I don't think anyone here would say that risk is 0%, but after looking at all the available information, it seems like a great investment long-term. And that is what ohm and others try to say, as far as I understand it...
Nice try. You said from PIVOTAL MONO after they had already said they'd need more from INVESTIGATIONAL trial.
Rofl
Yes, you are all into facts, unlike that dubious poster who continously insisted that they would need safety data from pivotal mono, who was unbearable. Everyone explained it to her, but she wouldn't listen and repeat that for months... Oh wait...
And that poster also had no position because the company was goingvtowards BK and then all of a sudden had a "starter position"...
"Though this be madness, yet there is method in 't."
Since you are a seasoned investor: do you really believe that regularly writing "OTC scam", "31ct. Hilarious!" "Smeary carpet dealer!" does you or the others here any good or is appropriate? ^^
Perhaps such posts would be more justified if we again are left with nothing at November 1.
Right, I overlooked the irony ;)
You're welcome. I think you have a very decent position at an excellent price-level long-term; given that, personally, I don't see the rationale for buying substantially more without a clear path forward (financing and a partner). I mean, it's not like your average is $1 and you could lower your average significantly.
How much more it drops, no one knows. And if the deal should fall through, it will be getting ugly anyway: raising funds to cover the monthly expenses, let alone raise enough for possibly going it alone at .30, won't be fun.
All IMHO
If the best scientists in the US want to work with leronlimab and believe it to be promising in multiple indications besides HIV, I doubt we overestimate the science.
Apart from this, the science has already been proven and validated in HIV combo and mono.
On the other board, ohm recently posted a comprehensive list of medical papers examining the role of CCR5 and CCR5 antagonists. These papers are real and the science behind it too
I'd recommend not to watch the SP daily. Since you can easily afford to entirely lose your position, I'd mentally write it off and only check once in a while.
AND: Despite some management and strategic failures, CYDY is definitely not an OTC scam.
The SP is a function of investors being mostly invested in this through private placements and managing their risk by keeping warrants and selling common shares on the open market. Non-accredited investors like most of us are the suckers (for now) and merely absorb the selling of these common stocks and therefore are in a difficult position, in which it is quite complicated to guess where the bottom is.
Anyway, I still believe that even in the worst case scenario this is worth way north of $150m.
I wouldn't speak of IQ, if I constantly used 'LMFAO...'
The micro cap rodeo show. Every CEO of the companies presenting sits on a fake bull and will only be allowed to talk as long as he can hold...
Yeah, if SP isn't over at least $1 by end of Q2, something has gone terribly wrong...
Yes, Oncosecs SP development is impressive ;) PhantomLord on the Marker board exposed you very well.
Also, why does the CEO matter? "CytoDyn is toast" anyway, since Glaxo developed a 2-month-injection of their drug, right? ;)
Yeah, we should get the CEOs from Oncosec and Conatus that you were pumping :)
I'm not calling for Nader to be replaced. But if he can't get BLA submitted and a deal done by year-end or beginning of next year, I doubt that he will have much support left (at least that's my impression from public and private exchanges on both boards).
With GvHD, they have postponed a very low-hanging fruit last year to advance cancer. Well, TNBC interim results still far away. True, this might have been mostly on the lame duck Pestell (though this remains to be seen in the course of the lawsuit), but seriously: after several weeks/months delay with no first patient injection, it should have occured to Nader and the BOD to check on what their CMO is (not) doing much sooner... IMO.
I'm not really happy with the strategic performance of the company recently either: e.g. Mulholland's offer to 'loyal shareholders' tanked the SP. And btw, what about the prognostic test that was our best shot for non-dilutive financing as we were told (I have to assume it's a dead end).
Stability data delay is on the company. They should have prepared data for all doses.
And if a 3rd line cancer drug like Copiktra can get $15m up-front for Japan, it can't be impossible to win an interested party there for licensing leronlimab for $25-30m.
Still hoping for that 90m deal coming to fruition soon.