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There will be no cancer data announced anytime soon without opening bigger trial sites, and for that we need up-front and milestone payments from a closed deal.
We need at least five patients in either protocol, after 3 or so cycles of chemo probably, so that's 63 days after point x, whem five patients are enrolled. At current enrollment pace, well, you get the idea... (Hint: it's not Q4 as in the investor presentation).
As long as noteholders and warrant sellers put pressure on the SP, it will get more and more difficult to raise larger sums. This cycle must be broken by the 90m+ deal they hopefully close until year-end. From the financial perspective, they have no leverage. Hence IMO it would have been smarter to negotiate from a position of strength with cash in the bank, by outlicensing rights to ex-US territories.
How about a tiny deal for Australia, Japan or whatever that provides us with 30m to advance cancer and GvHD and open bigger trial sites? They had quite a bit of time to do that IMO and with Dr. Rae they have the right person to do it.
With 2 patients enrolled in 7 (or 3 months, if we discount the lame duck Pestell) we will not get interim results any time soon. Let's see: we need 6 patients or so, probably with 3-4 cycles of chemo, so 2 months after 5-6 are enrolled...
I wager approval is still indefinitely likely than your ever becoming a credible or successful biotech analyst...
You can guess whatever you want :)
They said Nov-Dec on last call. That was my point. 25:31-29:12 +3 months stability data
Um no? The same timeline as in the last call was confirmed. Nov-Dec
I didn't get this either. Will need to re-listen tomorrow (already bed time here in Europe), but I'm sure someone else here will help us clarify that topic :)
Yes, you are correct. That's what he said. Certain posters are making stuff up again.
Lol. I have to assume that leronlimab also blocks the receptors responsible for non-dilutive financing. Well, perhaps we'll get a partner PR AFTER HOURS, given last week's pattern :). Breaking the cycle of predictability.
Lol, and how does this explain why the news itself, i.e. the first TNBC injection is negative?
FDA requires them to have a couple of patients before reporting any results. So it'll take quite a bit more time at current enrollment pace before we get to know hard results...
We will know by Monday morning - if no PR, then it's gonna be a nothing burger (at least regarding the financial side). No medical news, no matter how good, will move the stock significantly...
I sense a disturbance in the force. Might be something real, or just desperation (the dark side clouds my force vision)...
John 20:29:
Then Jesus told him, “Because you have seen me, you have believed; blessed are those who have not seen and yet have believed.”
In the CYDY case, I prefer to be the incredulous Thomas though.
Of course I shift the target timelines accordingly when new info is available. Given the disastrous proactive interview, a deal in 4 weeks would surprise me.
No, unfortunately I cannot dislike your posts on iHub :)
"What a POS!"
"Bought more and will sell at $2. PUMPERS!"
I think they'll close a deal, but not in 4 weeks, but by year-end.
Ok, time for a cathartic laughter/comic relief.
https://imgflip.com/i/3bg2v0
WARNING! THIS LINK CONTAINS TOTALLY INAPPROPRIATE, OFF-TOPIC, LOW-QUALITY AND IMMATURE MATERIAL!
Suvorov is known for his rigorous DD. Surely, he will blow us away with his detailed explanation regarding imminent bankruptcy.
I think you have some good points.
While the FDA communicates that they want this adamantly approved, their actions speak differently, and they give their best to troll CYDY as hard as possible. Would it be better, if someone else was in charge? Who knows? Perhaps if we got a super-muscular ex-Gilead nobel-prize winning CEO that intimidated FDA reviewers by his mere presence, lol. We've got a good relationship with FDA insofar as the cancer and GvHD studies are approved rapidly and insofar as they didn't require 100 patients for combo trial etc.
Further, there is no excuse for not having the 700mg stability data ready by now, which delays BLA submission for 1 or even 1,5 months. This costs another 7.5m roughly, money CYDY does not have at this point. Moreover, it seems clear that Nader did not watch Pestell closely enough, which cost us dearly (quite understandable though - who could have suspected such a mess?).
And I agree that he shouldn't have had a bonus - not until we are OVER the finish line and SP reflects the progress. But shareholders approved it, and so be it.
At this point, we simply have to wait another five weeks to see whether the deal comes to fruition.
And let's not forget that Nader saved leronlimab from being shelved and failing (which is a huge achievent and many future patients will owe him their lives for this).
Agreed. This is out of Nader's control now. He has negotiated the deal and signed the term-sheet. Now it's up to the partner to transform it to a binding agreement. If they don't want leronlimab they can f*** off and miss that once-in-a-lifetime opportunity.
In five weeks we'll know more :) Have a nice day too and good luck.
Or perhaps the non-binding offer signed stated a deadline after which it must be transformed into a binding agreement, which happens to be in five weeks. Hence he said last week "They have six more weeks". So perhaps it would be prudent to wait five more weeks until calling him an idiot ;)
You must understand:two days ago, the company was on the verge of bankruptcy, mono data were real bad, and the Pestell lawsuit was going to destroy the company.
The most important quality of an ANALyst is his/her credibility, and here our good blogger sets exceptionally high standards.
I'm sure Nader will sum up the deal and the details on the next Proactive video soon.
Yes, screened is what I heard too
Thanks for this. Was difficult to hear sometimes.
I am glad that finesand always stayed truthful and stood with her opinion. She always believed in the company (on the verge of bankruptcy). She always knew we'd succeed. And she would never award herself coins to stick her posts on top in order to create the impression that she always was on the company's side. You rarely find such an extraordinary and decent human being! I'm fighting with my tears now..
Almost as credible as the good blogger who recently said she had no position, but now suddenly has a "starter position".
Look, I know biotechs.
We won't start the trial unless some BP partners with us or we get sufficient funds; filing those Phase 2 studies is a cheap way to enhance the value of the company during all on-going negotiations. This argument has been brought forward one hundred times now.
The CTC count of a single TNBC patient will not be disclosed due to FDA regulations; only data of a couple of patients are permitted to be disclosed.
You surely wanted to say ..."the CEO is said to have pushed out...", since we only have the testimonial of a fired employee while the company has yet to be heard, right? :)
I 100% disagree
We shall see. I don't buy most of RP's statements, e.g. about the colon cancer IND: if he had concerns about the dosis of the chemo, he could always have started with a lower dose in the first place, and not designing a different protocol and then later say "Oh no, we need to start with a lower dose" - doesn't make sense to me, let alone that NP who has always been caring about patients and fulfilling the requirement of the FDA would endanger patients.
Buy yes, we will know CYDY's perspective soon (or never know, if they settle). I will be glad to revise my opinion based on new facts
Since Pestell told everyone in November he was in advanced negotiations about the test with third-parties (bullshit IMO) and the company always gave the impression that the prognostic test was fully developed, this might already be sufficient to justify RP's firing for cause: the need to hire a specialist wouldn't delay the development process by two years, obviously.
So while being CMO, it seems to me that it might be the case that RP was not transparent about the actual status of this test. It will indeed be interesting to watch the outcome of this.
If more work on the test is required, they should sell the damn thing immediately IMO.
It will be interesting to learn about the exact status of the test - whether it might take two more years to fully develop it as stated in the annual report (which might amount to RP effectively misleading everyone about its status) or whether they can proceed with their application and the statement in the report was just phrased extra-carefully.
Today's meeting is about the prognostic test, not the pivotal mono trial...
I am sure that Amatuer missed that passage by chance :D
Will probably be good for CytoDyn to collect some testimonials of patients on their website after approval and encourage them to actively share their experiences with leronlimab within the community.
CytoDyn Files a Phase 2 Protocol with the FDA for Leronlimab (PRO 140) and Regorafenib as a Combination Therapy for Metastatic Colorectal Cancer
Download as PDFAugust 08, 2019 6:00am EDT
VANCOUVER, Washington, Aug. 08, 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 the filing of a Phase 2 protocol with the FDA for a combination therapy of leronlimab and Regorafenib in patients with metastatic colorectal cancer (mCRC). The study is to be conducted by lead principal investigator, John L. Marshall, M.D., Director, The Ruesch Center for the Cure of GI Cancers Frederick P. Smith Endowed Chair, Chief, Hematology and Oncology Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C.
This is a single arm study with 30 patients designed to test the hypothesis that the combination of leronlimab, administered as a subcutaneous injection, and Regorafenib, administered orally, will increase progression-free survival in patients with CCR5-positive metastatic colorectal cancer.
“This is the third clinical program that CytoDyn has underway in the oncology space,” stated, CytoDyn President and CEO, Nader Pourhassan, Ph.D. “We recently announced the first injection in our clinical trial using leronlimab to treat metastatic triple-negative breast cancer (rmTNBC), under the supervision of Jacob Lalezari, M.D. In addition, our Phase 1b/2 trial using leronlimab in treatment-naïve mTNBC patients is under the supervision of Massimo Cristofanilli, M.D. professor of Medicine in the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine.”
“With results from multiple pre-clinical studies in various cancer indications, including MBC and mCRC, we are optimistic about the potential of leronlimab to provide a new therapeutic option for individuals diagnosed with invasive cancer each year in the United States. We again thank the patients who have agreed to participate in our trials and endeavor to provide each of them with clinical benefit,” concluded Dr. Pourhassan.
Patient Treated with Leronlimab (PRO 140) for Metastatic Triple-Negative Breast Cancer under Emergency IND, Launching CytoDyn into Oncology
Download as PDFAugust 06, 2019 6:00am EDT
VANCOUVER, Washington, Aug. 06, 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 the injection of the first patient with metastatic triple-negative breast cancer (“mTNBC”). The patient will be treated with leronlimab by Jacob Lalezari, M.D., currently Chief Executive Officer of Quest Clinical Research. Dr. Lalezari is also a principal investigator in CytoDyn’s HIV clinical trials with leronlimab.
“This patient has a particularly aggressive type of mTNBC and is being treated under emergency IND regulations of the FDA,” stated Dr. Lalezari. “With the exciting preclinical studies in cancer metastasis completed by the Company, I believe that leronlimab represents a new potentially therapeutic modality in mTNBC.” Dr. Lalezari has authored more than 75 peer-reviewed articles and been a principal investigator in over 200 clinical trials with a particular focus on first-in-man and proof of concept studies.
The use of leronlimab for mTNBC under the emergency IND by Dr. Lalezari is in addition to the Phase 1b/2 trial with leronlimab for treatment-naïve mTNBC patients under the supervision of Massimo Cristofanilli, M.D., who is an expert in translational research treatment of patients with mTNBC and professor of Medicine in the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine. Results from the Phase 1b/2 trial for mTNBC will dictate the Company’s regulatory pathway, including the potential to seek Breakthrough Therapy Designation and accelerated approval with the U.S. Food and Drug Administration (“FDA”) for the use of leronlimab in mTNBC. Leronlimab has been granted Fast Track designation for mTNBC by the FDA based on a greater than 98% reduction of metastatic tumor volume in a murine xenograft model.
“Today marks a milestone in our Company’s history, a first step into the oncology space,” stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. “It is equally important to note that leronlimab has already completed eight successful clinical trials and has been dosed in over 800 patients in our HIV programs, without any drug-related serious adverse events (SAEs),” he continued. “With results from multiple preclinical studies in various cancer indications, including mTNBC, we are optimistic about the potential of leronlimab to provide a new therapeutic option to many patients.”