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Some minds are so independent that they even dare to think independently from independently thinking minds thinking that others don't think independently!
She really is a bullshit/con artist. Really hard to find someone with such an intellectual disingenuity, mixing facts with fiction. That freak show here and especially on Yahoo makes one cringe really hard...
I agree that slowly everything falls into its place. Inflection point shouldn't be too far away, really.
CytoDyn Sponsored Research Reaffirms the Role of CCR5 in Cancer Biology and Provides a New Potential Cancer Treatment Modality
Exciting results from Daniel Lindner, M.D., Ph.D. at the Cleveland Clinic with leronlimab on human colon carcinoma
VANCOUVER, Washington, Aug. 02, 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, today announced the successful completion of a series of pre-clinical studies by Dr. Daniel Lindner, M.D., Ph.D. at the Cleveland Clinic with leronlimab (PRO140) on human colon carcinoma in humanized mouse models.
The ability of leronlimab to inhibit colon carcinoma was investigated in mice with a human immune system. The data indicate that rapid tumor growth is associated with high CCR5 expression and that leronlimab can suppress colon carcinoma growth in both low and high CCR5 expression tumors. The results also define a potential role for the human immune system in tumor control. These results together provide the basis for the potential use of leronlimab as a new therapeutic modality for human solid tumors expressing CCR5.
"The results that we are announcing today provide a potential, significant opportunity in oncology,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. "We are encouraged by the pipeline of opportunities leronlimab continues to create, with potentially accelerated path to approval in several cancer indications given the high unmet medical need and leronlimab's proven safety record in over 800 patients dosed to date across several therapeutic indications with no drug-related serious adverse advents. A tremendous thanks to Dr. Lindner at the Cleveland Clinic for his design and oversight of these key pre-clinical studies," Dr. Pourhassan concluded.
"I am honored to have had the opportunity to investigate the role of leronlimab in cancer biology,” stated Daniel Lindner, M.D., Ph.D. at the Cleveland Clinic. "Our research provides ground-breaking insight into basic cancer biology, immune involvement in cancer suppression and has identified a potential new therapeutic modality to influence cancer patients' survival."
Lol. Yeah, the most prolific HIV experts work with CYDY because they're convinced it is snake oil. Makes sense.
That SP movement is totally nuts. I'll triple at around 3.30, if the 52 week low doesn't hold - who knows how low they can take this.
Actually, for intelligent investors it is good when markets and individual stocks that have or promise great value go down a tremendous amount, because they will be buyers when the stock gets more and more attractive and accumulate shares over time.
I'm glad that this stock has never been anywhere near its fair valuation so that I could build my position over the last 9 months :) Anyone who bought CYDY over the last years will be nicely rewarded in a couple of months IMO.
Seriously, you didn't even listen to the CC, so how do you know she presents facts?
For example, she conveniently didn't mention that revenues "the second year" was an obvious blunder by Nader when speaking quickly. In line with previous guidance we will have revenue in 2Q.
The probability that RP answered her email is close to zero: he wouldn't comment to an unknown person on that matter and not even say that he can't comment at this point.
Of course IMO. The fact that SeaofSand and her other colleagues publish dozens of comments on yahoo, SA etc. to bash the company doesn't add to her credibility.
I am sure you sent the e-mail not to RP, but to one of your many aliases, and then got that response :)
Lol, as if it has never happened in history before that people post unfounded commentaries below YouTube videos...
You can easily turn such an argument around... We will see whether an explanation is offered; since nobody knows for sure what's happened, one should be cautious speculating about RP - audiatur et altera pars...
CytoDyn Finalizes Development of Receptor Occupancy Test to Guide Pivotal Monotherapy Discussions With the FDA
Download as PDFJuly 25, 2019 6:00am EDT
- FDA face-to-face meeting granted to discuss pivotal monotherapy trial
- Conference call for investors and media on Tuesday, July 30, 2019 at 4:00 p.m. ET with introduction to Dr. Jonah Sacha for CURE and PrEP programs, Dr. Bruce Patterson for CCR5 receptor occupancy for HIV and cancer, and Dr. Jacob Lalezari for TNBC trial
VANCOUVER, Washington, July 25, 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, today announced the completion of development of the Receptor Occupancy Test to measure the expression of CCR5 in HIV and tumor cells that are occupied by leronlimab. Development of this test could more precisely guide CytoDyn in identification of patients at screening for monotherapy.
To date, over 830 HIV patients have participated in clinical trials with leronlimab (PRO140), including over 600 patients in ongoing and previous monotherapy trials. There have been no drug related serious adverse events (“SAEs”) reported in any of the HIV patients treated with leronlimab. In addition, the response rate for the first 10 weeks of leronlimab monotherapy in HIV patients has approximated 95% with the 525 mg dosage. Identifying the patients who can respond to leronlimab monotherapy at the screening is critical for therapeutic success. As such, the development of the Receptor Occupancy Test is a significant milestone that may further increase the monotherapy response rate.
“The development of the Receptor Occupancy Test is an important milestone for CytoDyn because it may allow more precise screening for leronlimab monotherapy,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. “Over 600 HIV patients that have taken leronlimab as a single agent over the years have had no drug related SAEs,” continued Dr. Pourhassan. “The potential for leronlimab to be a safe and effective treatment for HIV with highly accurate dosing is an important driver of continued excitement and support from key opinion leaders within the medical community,” Dr. Pourhassan concluded.
Significantly, CytoDyn has been granted an in-person meeting with the U.S. FDA to discuss its pivotal monotherapy protocol that could lead to label expansion approval should leronlimab have its first approval as a combination therapy. To date, 110 patients have reached approximately one year of monotherapy trial with six patients in the extended portion reaching almost three years. Four patients in the extension arm of a previously reported Phase 2 monotherapy trial have continued on leronlimab monotherapy for nearly five years with no drug related SAEs and no viral breakthroughs.
The Company will host a conference call for investors and media on Tuesday, July 30, 2019, to discuss the latest developments, provide a comprehensive update about CytoDyn, along with comments from Drs. Sacha, Patterson and Lalezari.
Date: Tuesday, July 30, 2019
Time: 4:00 p.m. ET/1:00 p.m. PT
Dial-in: 877.407.2986 U.S. and Canada
201.378.4916 International
At some point, however, they might have to accept an offer, even if it is not optimal (unless they want to raise again - but at these price levels - I don't know...)
Honestly, I'm not a huge fan of Nader, either, but it's not his fault that the FDA happens to change their mind as to the safety data requirements every couple of months or so, which pushed back everything by at least 6 months or so. This is a super-safe and very efficient product for patients in dire need, yet FDA does not really seem bother to provide them with a quick path forward, which is essentially pure arbitrariness. I don't think they would have pulled this stunt with a company like Pfizer.
With the current cash burn and low funds I'm not sure that CYDY will be able to move forward full-speed on all fronts (GvHD, pivotal mono, TNBC) simultaneously.
Come on, Merck, Pfizer or whoever, do a partnership with decent up-front money and significant milestones/royalties and get this platform drug through all indications/trials quickly!
Preliminary results from a Phase 1b proof-of-concept study assessing a single subcutaneous injection of Gilead Sciences' (GILD -0.2%) HIV capsid function inhibitor GS-6207 in HIV-positive patients showed significant reductions in HIV-1 RNA compared to placebo. The data were presented at the International AIDS Society Conference on HIV Science in Mexico City.
No serious adverse events or discontinuations were reported.
GS-6207 has Breakthrough Therapy status for multidrug-resistant HIV.
Development is ongoing.
No, not really, but they increased visibility of the company by doing interviews on Yahoo Finance etc. Can't imagine this offer brings in much though. Will be interesting to see the current cash burn in the new quarterly report that will be due soon.
No, not really. If you scroll two or three years back the general attitude here was quite euphoric and the SP was higher, but not THAT high. And even in February when it seemed that BLA was submitted in March and TNBC to start, and even Fine and Suvorov appeated euphoric, the SP wasn't significantly higher.
Actually, euphoria is an excellent contra indicator, since retail investors often suck (not this board though!). That is also why biotechs that have 20k followers on ST usually fail, an interesting correlation.
You actually forgot one point: last week too in a video NP said he wouldn't make a prediction anymore regarding TNBC in order not to miss it again - something he now contradicted by again giving a timeline.
TNBC first injection will be done when it's done, which is fine. I will not take any of their timelines serious now and take heart in the fact that eventually it's going to happen...
If something like this was legal, that wouldn't be right. I doubt they could say: "Hey warrant holders. We will be bought out at $x. Quick, sign a NDA and tender"
And since this has been resolved: where is the term sheet?
They could also encourage warrant holders to exercise at their original price by increasing the SP through a licensing deal.
Since they haven't received a term sheet for the test yet, the question must be allowed what they have been negotiating during the last 8 months...
Possible, but IMO just as likely as Donald Trump will run for the democrats at the next election...
Yes, that's what he said. But part of being a critical investor is questioning what he says, since a CEO will obviously tell anything to support his company (see TNBC injection).
For a deal regarding the prognostic test, FDA approval/go to file the submission is not necessarily needed, i.e. they could have long ago inked a deal with milestone payments: A symbolic amount now, x on filing, y on approval and so on.
Still doesn't make any sense to me that one would need so much time to propose a first term sheet.
I don't think so. Seems like we will oscillate between .38-.53 until financing is secured (one way or another). Since the current TO hasn't caused a retest of the .30s (yet), we might go up to the .50's again.
But definitely seems like they are fishing in the dark right now with no news to support a TO as of yet.
After reading your somewhat ironical posts now, I was reminded of NP statement that RP has been spectacular in prognostic test licensing negotiations. Seriously, how can one say that he has been spectacular if they haven't yet received a term sheet to negotiate on as of last month?
Right - good point. Will be interesting to see how the story unfolds. In any case, Marker will be worth far more than today...
Possibly, but it is always problematic to use inflated buyout prices in past hype periods for future predictions. I don't think Gilead and especially Celgene would pay that much again today.
I wouldn't be too harsh... Not that I necessarily agree with IndexGuy, but "BP is back on the table" "BP is interested" etc. is soft company-speek and can mean anything. We don't know at what level discussions take place and how serious the talks are etc..
Whether they can negotiate a decent deal yet remains to be seen. Will be pretty interesting to see this unfold.
That company is a total joke. CEO says that a RS won't be needed since several data readouts would support a higher SP above 1, and a couple of days later they do a RS.
I prefer to go with the yes/no oracle instead. Lol. It says we will definitely get a deal in 2019...
http://www.freeoracle.com/index.html
That's the million $$$ question. To me, it makes no sense to open another TO unless they have a plan and expect substantial news till end of July. But I have stopped reading too much into their words and actions on the financial side. Problem is one can rationalise almost everything - small raises mean that a deal is close, not putting put more news before the first TO closed means the same etc., which was all way off.
It's not that they want to immediately initiate a Phase 2 study in NASH if the pre-clinical results are positive - it's simply a means to further enhance the value of the company, while only spending a couple of thousand dollars. An option for NASH in Phase 2 adds a lot of value, especially since the future of NASH treatments seems to lie in a combo approach - Leronlimab, being extremely safe, is ideal for a combo treatment, e.g. with Genfits or Galectin's molecules.
Also, she sometimes pronounces leronlimab as leronlimAAAAb. Very suspiscious. Coincidence? Don't think so...
Yeah, exactly! The potential is just insane... I shouldn't be having 60% of my portfolio in it, but I like the story so much - little, virtually unknown company, licenses leronlimab from Progenics, which eventually might turn out to be one of the most important molecules of the 21st century.
I agree ;)))
CytoDyn Announces Major Discovery for its Monotherapy Indication
CytoDyn and IncellDx Report the Successful Development and Validation of an Assay to Assess the Responders for Monotherapy HIV Patients
This assay could predict in 2 hours the responder’s rate for a monotherapy patient candidate and the appropriate dose for each patient at the time of screening
VANCOUVER, Washington, June 18, 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 significant progress in securing the therapeutic effect and safety of leronlimab (PRO 140) with the development of an assay that can reliably determine a patient’s CCR5 status. Currently, all new patients in the Company’s monotherapy trial are being evaluated with this newly developed screening-level test with the objective of identifying patients expected to respond to a monotherapy versus those not expected to respond due to CCR5 density.
“The development and implementation of an assay that can rapidly and accurately identify potential responders to leronlimab offers a tremendous technical advancement with the potential to more precisely target leronlimab on patients most likely to respond to treatment,” stated Dr. Nader Pourhassan, President and CEO of CytoDyn. “We are excited about our partnership with IncellDx to provide the technical support to explore the power and potential of CCR5 inhibition,” continued Dr. Pourhassan. “With over 110 HIV active patients on leronlimab monotherapy for almost one year and five patients from our original Phase 2 monotherapy extension now reaching almost five years on monotherapy without viral breakthroughs, we are very excited with our collaboration with IncellDx and Bruce Patterson, M.D., former Medical Director of Virology at Stanford University Hospitals and Clinics. With Dr. Patterson’s expertise, we are confident that we will be able to much more efficiently identify responders in HIV, and potentially in many other indications, including our ongoing cancer research.” Dr. Pourhassan concluded, “The continued clinical success of leronlimab in HIV underpins our soon to begin partnership with Thai Red Cross AIDS Research Centre for the PrEP clinical trial that will exclusively utilize leronlimab as a monotherapy.”
“The HIV-co-receptor CCR5 has both genotypic differences in patients, as well as being a highly regulated receptor with different amounts expressed on different cells under certain conditions such as inflammation. The development of a portfolio of assays, including CCR5 genotyping and the assay being reported today that reliably and timely identifies a patient’s CCR5 status, offers a leap in the understanding of potential response to treatment with leronlimab,” stated Dr. Bruce Patterson, CEO and Founder of IncellDx. “I am excited to continue the very positive and effective partnership with CytoDyn to potentially help bring leronlimab to the right patients at the right time, in furtherance of the clear opportunity afforded by personalized medicine,” concluded Dr. Patterson.