Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
NP responded last night to another poster, and here's his response"
"Absolute lie, 49 million existing shares were registered on a S3. Nothing to do with any sales
With best regards
Nader"
Feel free to include this in your future posts.
BROKE THE $3.50 CEILING AND HEADED TO $3.60!!!
CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients
VANCOUVER, Washington, April 27, 2020 (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 Company has submitted the clinical, and the CMC (chemistry, manufacturing and controls) portions of its BLA to the U.S. Food and Drug Administration (FDA) for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients. The FDA previously granted both Fast Track designation for leronlimab and rolling review for the Company’s BLA in HIV indication.
“The submission of the final two parts of the BLA is a significant milestone for the Company, and initiates its transition from a development-stage company to a commercial organization. We are excited about the opportunity to introduce a novel therapeutic to HIV patients. In addition to the BLA submission, once the ongoing investigative trial for leronlimab as a once-weekly monotherapy for HIV-infected patients has reached its objectives, we plan to initiate a registration-directed study. Leronlimab’s strong safety profile demonstrated in eleven clinical trials with over 800 people supports its long-term potential,” said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn. With the BLA filing for a combination therapy now complete, we are continuing our efforts on commercialization-readiness, as well as advancing leronlimab in the other important therapeutic areas of COVID-19, cancer and immunology. The BLA filing is a monumental achievement for our Company, and was made possible through the sheer determination and commitment of CytoDyn’s team and Amarex Clinical Research team led by Dr. Kush Dhody, Senior Vice President of Clinical Operations. I would like to especially recognize Dr. Nitya Ray, the Company’s Chief Technology Officer, whose work in leading the CMC program was very crucial to CytoDyn. Dr. Ray was also instrumental in consummating the Samsung Biologics contract to ensure we have sufficient large-scale biologics manufacturing capacity in place to meet the expected demand growth in a cost-effective and timely fashion. I would like to thank all of those involved for their tireless efforts,” concluded Dr. Pourhassan.
About Coronavirus Disease 2019
CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.
SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.
Who cares? The good news is that you showed he was completely innocent of selling a fake dream-catcher 30 years ago and the charge was dropped.
Thanks for showing he was innocent after all, but we already knew that.
"Prosecutors drop charges of selling phony Indian art"
"Viti explained that a witness, the owner of one of the businesses that sold Pourhassan's dream catchers, has said "there were actually no misrepresentations made to him about the goods" Pourhassan sold him.
"Pourhassan had an employee who said she made dream catchers with materials he supplied to her. The woman is American Indian."
Great catch! Thanks for showing he was innocent after all, but we already knew that.
"Prosecutors drop charges of selling phony Indian art"
"Viti explained that a witness, the owner of one of the businesses that sold Pourhassan's dream catchers, has said "there were actually no misrepresentations made to him about the goods" Pourhassan sold him.
"Pourhassan had an employee who said she made dream catchers with materials he supplied to her. The woman is American Indian."
YES, INCREDIBLE RESULTS!!!
Southern California Patients Treated with Leronlimab for COVID-19 under Emergency IND: 4 Patients with Moderate Indications Removed from Oxygen; 3 Patients Discharged from Hospital; 1 Patient Scheduled for Discharge Today; 1 Patient with Severe Indication!
Blood Samples at Day 0, 3 and 7 for Severely Ill COVID-19 Patients Clearly Indicate Leronlimab Has Significantly Reduced the Cytokine Storm in All (7) Patients and All Patients Demonstrated Immunological Benefit at Both Day 3 and Day 7!
Severely Ill COVID-19 Patient at Leading Southern California Medical Center Extubated Three Days After Treatment with CytoDyn’s Leronlimab; Two Moderate COVID-19 Patients Removed from External Oxygen Following One Day of Treatment with Leronlimab!
Great find! Thanks for consolidating these results!!!
Can you imagine if you had been lucky enough to have bought one of those from some guy almost 30 years ago only to find it that guy later got his doctorate, became the CEO of a small biotech and turned it into a billion dollar company that will soon become a multi-billion dollar pharmaceutical named CytoDyn? WOW! Now that would be a REAL collectable! Imagine what it would be worth today! Great find!!!
BTW, I just looked and saw where they dropped the misdemeanor charge. Even still, I'd love to have one of those collectables!
INCREDIBLE INTERVIEW - Thanks for posting the link to the OAN Interview. New investors need to watch this in its entirety! This interview just underscores the large number of binary events and catalysts that are going to continue to propel the share price forward. Can't wait until the CYDY investors call this Monday at 1:00 ET when they're going to announce some major news! Better load up before 1pm!
Just wait until Monday afternoon - it may double.
Well, you can always sell some shares on Monday but I'd suggest you wait until after the conference call at 1:00 ET because we're all expecting incredibly good news.
My concern with Cramer is that he's buddy, buddy with AF and they have a long, notorious history from The Street with coordinating short attacks together.
I'm well aware of HCQ. Please refer to post 70288.
I believe they're referring to self medicating which nobody should do.
Much of the selling comes from day traders jumping in and out.
Yeah, I now recall that, too. I think this will be the first conference call that will be held mid-day, and tells me this will probably be the most important call to-date. I can't wait to watch the sp respond realtime.
Yeah, it already has. LOL
CytoDyn to Hold Conference Call to Provide Updates on Completion of BLA Filing for HIV, Timeline for Potential Approval of Treatment for COVID-19 Patients, and Two Publications, Including The New England Journal of Medicine
VANCOUVER, Washington, April 24, 2020 (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 Nader Pourhassan, Ph.D., President and Chief Executive Officer, along with Drs. Bruce Patterson, M.D. and Jacob Lalezari, M.D. will host an investment community conference call on Monday, April 27, 2020 to provide a comprehensive update on several recent developments.
Management will dedicate approximately 45 minutes to address questions from analysts and investors.
Date: Monday, April 27, 2020
Time: 10:00 a.m. PT / 1:00 p.m. ET
Dial-In: 877-407-2986 US / 201-378-4916 International
I was referring to the cc on 12/17
I just found it:
Date: Tuesday, December 17, 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
That was after hours (4pm ET) as I recall. The sp didn't pop until the following morning.
You're contradicting yourself.
Those are usually T trades.
This Drug Could Calm the 'Cytokine Storm' That's Killing Coronavirus Patients
https://www1.cbn.com/cbnnews/health/2020/april/this-drug-could-calm-the-cytokine-storm-thats-killing-coronavirus-patients-nbsp
Yes, from everything that I've read and been told by physicians who prescribe it for their patients is that it works mostly for mild to moderate cases. The good news about Leron is that it appears to work for all three cases (mild, moderate, and severe) and is clearly a much better option than HCQ, but it's all they have for now.
This only took me 5 minutes to collect for you. Enjoy!
Over the past three weeks, there's been debate over whether hydroxychloroquine, a drug used for decades to treat malaria, can help ease the symptoms of Wuhan coronavirus. During White House press briefings, reporters have done their best to shoot down the possibility.
But doctors around the country and the world are using it and seeing positive results.
First, in Los Angeles:
Dr. Anthony Cardillo said he has seen very promising results when prescribing hydroxychloroquine in combination with zinc for the most severely-ill COVID-19 patients. "Every patient I've prescribed it to has been very, very ill and within 8 to 12 hours, they were basically symptom-free," Cardillo told Eyewitness News. "So clinically I am seeing a resolution."
Cardillo is the CEO of Mend Urgent Care, which has locations in Sherman Oaks, Van Nuys and Burbank.
He said he has found it only works if combined with zinc. The drug, he said, opens a channel for the zinc to enter the cell and block virus replication. "We have to be cautious and mindful that we don't prescribe it for patients who have COVID who are well," Cardillo said. "It should be reserved for people who are really sick, in the hospital or at home very sick, who need that medication. Otherwise we're going to blow through our supply for patients that take it regularly for other disease processes."
New Jersey:
Dr. Stephen Smith, founder of The Smith Center for Infectious Diseases and Urban Health, said on “The Ingraham Angle” on Wednesday night that he is optimistic about the use of antimalarial medications and antibiotics to treat COVID-19 patients, calling it “a game-changer.”
Smith, who is treating 72 COVID-19 patients, said that he has been treating "everybody with hydroxychloroquine and azithromycin [an antibiotic]. We’ve been doing so for a while.” He pointed out that not a single COVID-19 patient of his that has been on the hydroxychloroquine and azithromycin regimen for five days or more has had to be intubated.
Around the world:
An international poll of thousands of doctors rated the Trump-touted anti-malaria drug hydroxychloroquine the best treatment for the novel coronavirus. Of the 6,227 physicians surveyed in 30 countries, 37 percent rated hydroxychloroquine the “most effective therapy” for combating the potentially deadly illness, according to the results released Thursday.
The survey, conducted by the global health care polling company Sermo, also found that 23 percent of medical professionals had prescribed the drug in the US — far less than other countries.
"Outside the US, hydroxychloroquine was equally used for diagnosed patients with mild to severe symptoms whereas in the US it was most commonly used for high risk diagnosed patients,” the survey found.
The medicine was most widely used in Spain, where 72 percent of physicians said they had prescribed it.
That's correct. Many are questioning the age and condition of the patients who were given HCQ. As the FDA head said, let's wait for the clinical results before passing judgement. I'm clearly a long on CYDY but until we have Leron or other options available, I would like to see them keep all options open. Unfortunately others would like to see HCQ dragged through the streets for political reasons.
And to be clear, I'm not arguing whether it is or is not effective, but many physicians in this country and other countries around the world believe that it is effective based on the results they're seeing, which is why many countries including the UK and India have restricted the exporting of HCQ in order to maintain their supply. I have first-hand knowledge of physicians who do believe it's working, so I'm not going to base my opinion on just what I read, but also what I'm being told by physicians who continue to prescribe it, as we speak, because their patients are being released from hospitals every day after using it. These physicians and many other countries including the UK, Europe, and India disagree with the NIH, so I'm not going to quickly dismiss HCQ as being ineffective.
The mainstream media is hyping a “study” with data culled from Veterans Health Administration hospitals to justify their attack on Hydroxychloroquine, an anti-malaria drug that President Donald Trump is fighting to provide to suffering people. ABC White House correspondent Jon Karl agitated against Hydroxychloroquine in Trump’s Tuesday White House Task Force briefing, citing this VA study. FDA commissioner Stephen Hahn said “This study is a small retrospective study at the VA” and stressed that results of clinical trials, in progress, are needed.
The study cannot be used to credibly attack Hydroxychloroquine because the drug was given to sicker veterans more likely to die anyway as opposed to healthier people. The study was posted on the Internet but not reviewed by other scientists. The study claims 22 percent of people given Hydroxychloroquine plus azithromycin died, whereas only 11 percent died with regular care, but the study even notes that there’s no way to discount other factors contributing to the deaths of patients given Hydroxychloroquine plus azithromycin. One of the authors of the study has a patent application pertaining to Coronavirus and another author took a research grant from Gilead, which is developing a competitor drug to Hydroxychloroquine (the study claimed these competing interests were unrelated to the study itself).
Wrong! It's well known that not even Lero can reverse organ damage, but the majority of patients are not suffering from organ failure/damage.
"So Lero success is not guaranteed in majority of patients"
...and when they try to save face in front of their friends and family after urging them to jump in at the wrong time.
"Funny how certain people's sentiment changes with their current position."
My point is that the people who said the license deal wasn't going to happen in Dec are the same negative Nancy's that are now saying the BLA isn't going to be submitted next week or this month. And I'm glad they're saying that because it tells me the BLA submittal isn't baked into the current sp, which means the submittal announcement "may" cause a significant jump in price similar to what we saw following the licensing deal announcement (but not percentage wise).
"We have a 1/365 chance of him submitting that BLA next week."
I disagree. It amazes me how chronic pessimism clouds one's ability to see the future.
As I told you yesterday, I leaked it.
All right! Now I know it's on. I'm going to sleep good tonight!!
Put me down for an LIT - shaken, not stirred.
They haven't scheduled it yet. NP said in an interview earlier this week that they were hoping to schedule a call late next week. I suspect it's tied to submitting the BLA, so it may be they're waiting for confirmation before announcing the date/time for the call.
Because he was saying how extremely impressed he was with what he's seeing, and he wanted to assure everyone that his opinion wasn't biased towards an investment in CYDY.
I don't know for sure, but it may be to avoid questions about being biased towards Leronlimab given that he's involved in the trials and works closely with the FDA.
"If you really believe it, aren't you mortgaging the house to buy."
I'm counting on it. I had to drop off the call but I heard him say we're very close now (heard that many times) but I saw where someone said that he mentioned next week. I think that's the reason for next week's conference call and that he's just waiting for confirmation before he schedules the call.
Yeah, it's a little confusing as to when a broker can lend your shares, and I think they intentionally make it that way.
I heard a rumor that Gilead is paying shills to troll this board. Is that true?