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They normally plan these conference calls weeks in advance, but this one was scheduled at the last minute. Hmmmm...
CytoDyn to Hold Investment Community Conference Call on May 20, 2019
VANCOUVER, Washington, May 16, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY) announces that Nader Pourhassan, Ph.D., President and Chief Executive Officer, and Richard Pestell, M.D., Ph.D., M.B.A., F.A.C.P., F.R.A.C.P., Chief Medical Officer and Vice Chairman of the Board of Directors, will host an investment community conference call to provide a comprehensive update on the Company.
Date: Monday, May 20, 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
Thanks Chump! I see that he's still mentioning they're working on the license agreement and expect to announce real soon.
It is BOD's job to present the plan next week
And how do you replace the 40c share with the 26.67c shares w/out selling and buying within 30 days using your example?
Imagine, you have your 100k shares and 50k Warrants. The latter gives you 75k shares at 26.67c/sh now - so you can dump your 75k - 100k shares at current price now.
Thanks. I thought she was suggesting 11.5 months for enrollment.
Thereafter you add 11.5 month for the duration
CytoDyn Files Pivotal Trial Protocol for HIV Monotherapy with FDA
After four years of monotherapy trials, data is now available to submit the long-anticipated pivotal trial for monotherapy to the FDA
Trial will include 10 weeks of induction therapy to identify which patients are likely to respond and which patients can safely return to their original HAART regimen
VANCOUVER, Washington, May 15, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that it has filed with the U.S. Food and Drug Administration (FDA) the pivotal trial protocol for leronlimab as a monotherapy for HIV patients. The latest investigative monotherapy trial for HIV has now produced sufficient data for the Company’s Key Opinion Leaders to design a monotherapy pivotal Phase 3 trial. The objective of this trial is to assess the treatment strategy and clinical safety of using leronlimab subcutaneous (SC) 700mg weekly dose as single-agent induction therapy followed by leronlimab SC 525 or 700mg as maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection.
In this study, patients will receive a combination of existing retroviral regimen and leronlimab 700 mg SC for four weeks (the overlap phase) before shifting to weekly leronlimab 700mg monotherapy for 10 weeks (the monotherapy induction phase). Subsequently, patients will be randomized 1:1 to leronlimab 525mg (Group A) or leronlimab 700mg (Group B) for a 36-week monotherapy maintenance phase. Success with this monotherapy trial may allow the Company to file a BLA for label expansion in the event leronlimab receives FDA approval for HIV patients as a combination therapy with HAART.
Robert T. Schooley, M.D., Professor of Medicine, Division of Infectious Diseases, Vice Chair, Department of Medicine, Co-Director, Center for Innovative Phage Applications and Therapeutics, Senior Director, International Initiatives, University of California, San Diego, commented: “The development of simple and well tolerated oral daily treatment regimens have transformed the face of HIV disease for most patients with the virus. Nonetheless, there remain people for whom daily oral therapy is a challenge. This group of patients has driven ongoing interest in the development of longer acting regimens that can obviate the requirement for daily oral dosing. PRO140, or leronlimab, is one of several agents under study with this goal in mind.”
Jacob P. Lalezari, M.D., Director of Quest Clinical Research, added: “As a longstanding investigator for CytoDyn, I have seen that many of our HIV positive patients express a preference for weekly subcutaneous leronlimab monotherapy and uniformly request extension treatment beyond 48 weeks in order to avoid returning to HAART therapy. In the minority of subjects who are non-responders, we are heartened by the fact these folks can return to their original HAART regimen without difficulty.”
“The testimony of patients who have taken leronlimab as a monotherapy in our previous clinical trials is very clear; patients who respond to monotherapy simply love it, and after 48 weeks they ask for extension to continue on monotherapy. We have not seen any extension patients ask to return to their HAART regimen of pills,” noted Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn. “A monotherapy with leronlimab, if approved, may allow patients with pill fatigue to maintain a disciplined compliance regimen. In addition, it may provide patients concerned about the possibility of developing one or more drug class resistances, to potentially maintain a suppressed viral load without the typical side effects or toxicity associated with HAART,” concluded Dr. Pourhassan.
Great post!!! - Thank you for putting things back into perspective!
These are not open discussions as everyone knows.
Can you share the link to where you got that information, because I can't find that anywhere.
GILD has already looked at CYDY and concluded that there is not enough promise and moved on.
Why are you sending us a link to an article that's almost 7 months old and has already been retracted?
If Pourhassan truly believes in the science, and the company, why isn't he investing part of his bloated salary in the company's stock?
So, how many offers do they have?
So telling world that they have many offers is sign of bs.
If they gave us their update this morning in a PR, there wouldn't have been a reason for the CC after the closing bell today.
Oh well....no PR this morning at 6:00 AM as some of us were hoping.
It's my understanding that Tony stepped down and is no longer part of the management team, so I wouldn't have expected him to be included in the salary increases.
Since the recent money gifts did not seem to benefit AC, I wouldn't expect any possible good news to include Gilead.
How'd you get his cell number?
And let's not forget the 500k shares given to the Chair...
Given the call is after the closing bell on Monday, I believe that any new information that's shared during the call only needs to be PR'd prior to the opening bell on Tuesday.
Previous posters have said any significant news would need to be Press Released before the call.
So if there's no PR on Monday, they're having a conference call to just tell us what we already know?
so if there is no PR on Monday morning, the CC will be just more of the same.
When did they sign up to attend the conference? I doubt it was within the last couple of days, and I certainly wouldn't expect them to cancel because of a pending deal.
You don't set up a traveling roadshow to wine and dine big investors if you are about to partner with BP.
I suspect they're so optimistic about the TNBC results that they're getting their ducks in a row for subsequent indications.
I hope this doesnt mean they are putting that on hold while they play with their monkeys
I think this reflects their optimism towards the TNBC results and filing the BTD than submitting the BLA for Combo/Mono.
We do not have FDA approval or the BLA fully submitted.
I don't believe its current value is $200m. This is the future value after getting FDA approval.
What's crazy is they have $200m stored up in drug and $150m valuation...
In Misiu's post on 1/25 after talking to Dr. NP, she said the following which I believe is another reason it's taken a little longer to initiate the TNBC trial:
TNBC - no patients injected at this point , they finishing preparation of the lab in Wisconsin for a blood test for CTC. It is a complicated process.
They almost done. They expecting patients starting treatment in one or two weeks. Dr NP will put PR when this will happen.
Many doctors from big oncology centers calling and asking to accept their patients , so when it will start it should not be very difficult enrollment.
Dr Pestell studies pointing to a VERY good results ..everyone exited about it ....
Add another $3m to the pot (just posted this morning). So that's another $8-9m in the last 24 hours?
https://ir.cytodyn.com/all-sec-filings/content/0001193125-19-023144/d685467d8k.htm
The following summary was included in the DM version of the article:
• Israeli scientists have developed new peptide structures that they say will target cancer without provoking side effects or tumor responses
• They compare it to the triple-threat drug cocktail used for AIDS, targeting the virus in many ways at once
• Three peptides are already used to target hormones the fuel tumor growth, but none that attack the tumor itself
• Many scientists are working on approaches like this Israeli team to develop peptides that can do everything in a multi-pronged attack
• But claims of a 'cure' are overstretched because the Israeli team has only conducted a 'first exploratory trial in mice' and some tests in petri dishes
• The team says human trials will take a few years
In his interview from a couple of days ago, he clearly says that submittal is still expected at the end of March, so I don't think there's been any last minute changes, but rather giving themselves a little buffer for any potential delays. If it had moved out and they knew they were going to miss Q1, they would have said Q2, not first half of 2019.
Is there an interpreter in the house? I don't speak jibberish..
TIA
I hope everyone had a happy, safe and relaxing thanksgiving.
Bro...you read it wrong. It says "Fifty percent (50%) of the options were fully vested and exercisable as of the date of the reported transaction, and fifty percent (50%) of the options will vest on April 8, 2019". The key word here is "exercisable" - not "exercised".
will share price sink to all time low?
I like the way that he summarizes the article"
CYDY is undergoing an extreme metamorphosis into “CytoDyn 2.0” as coined by Dr. Pestell during the call. Investors are choosing to look at having to do another monotherapy trial as negative when in fact it likely accelerates the process and the new data from CD03 monotherapy trial might lead to a breakthrough therapy designation. Instead of dwelling on past financings that led to dilution, investors should be looking at the licensing opportunities that seem imminent. If investors were to simply look at this company under a new lens as a platform technology that is assured revenue via a diagnostic in prostate cancer, as a phase 2 cancer company with 2 “shovel ready” indications, and a greater than 90% chance of approval as a monotherapy in HIV, they would see that a $150 million market cap based on 248 million shares outstanding is just too low.
I haven't seen a bunch of the old people did they throw in the towel and go home? Seems weird since we are closer then ever to pack up and leave now.
When the company it self places an intrinsic value of $.50c and gives Paulson people a free lunch with warrants as if $.50c discount is not enough the market reacts rationally.
I believe the questions that he conceded to Nader were about future funding and the direction of the company, which would ordinarily be addressed by the CEO and not CMO. And you have to remember, he's still the interim CMO for now, so he can't speak for the company just yet.
Grip - I think I saw somewhere that prior to Pestell's arrival, he was looking for a CEO to run ProstaGene. Sounds like running a company isn't where he wants to focus his time, but I could be wrong. The good news is that I thought I heard Nader say that he and Pestell will be attending several conferences over the next few weeks which leads me to believe Pestell, as the CMO, will be doing most of the talking when it comes to the science. People need to remember that Nader does most of the talking on these investment calls because he's the CEO, but now that we have a strong, well-known CMO on board, I expect Nader will now take a step back and let Pestell present at the dog and pony shows.
The approval for them to issue a RS expired on 8/23. They are not requesting approval again for a RS going forward according to the recent proxy statement (thanks again,Trding, for noticing that).