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I'd venture to say this is where we are at now: Definitely a lot for Cytodyn, The FDA and Samsung to discuss.
SBL shall obtain and maintain all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity (other than the Regulatory Approvals, which will be obtained or maintained by Client) that are required to Manufacture and ship the Product at the Facility and perform the Services.
7.3
Regulatory Inspections. SBL shall facilitate on-site inspections of the Facility conducted by Regulatory Authorities. SBL shall notify Client according to the applicable QAG provisions of any contacts or inquiries by the Regulatory Authorities, including inspections, Pre-Approval Inspections, sample requests, and written correspondence and its result, related to the Product, as further defined in the applicable QAG. Any expenses or costs incurred by SBL for such inspections including Pre-Approval Inspections at the Facility shall be borne by Client.
Laughing!!!
Let's see..nobody wants it? With OLE's still running and EIND running at full speed, trials completed, FDA in discussions for getting it to market, positive results. Quite the opposite, there's a bidding war in the background as to who is going to pay the most to partner up or buyout. Reminds me of the ol little rascals episode when Mr. Frank from the bank called and Spanky picks up the phone " not enough, call back later"
Cytodyn is well on it's way to winning, we're approaching the finish line ribbon with no one behind us in sight, clean cut, clear win, no need for a photo review.
Can you post the proof? Source? I'd like to see the information on the failure
Could Cytodyn be discussing funding with OWS? Steller results and all of the sudden OWS steps in for funding? Hmmmmmm
Shoe horn what in? Either you failed or passed, this isnt a high school test.
Cytodyns results are over the top great and discussions are for logistics, labeling and distribution. And, are you sure that OWS is not involved now? Possible funding for expedited manufacturing? OWS is a federal entity no?
I have dealt and still deal with Federal Government regulators. I suggest you read title 21. You're post is way off
Agreed and exactly!!! Cytodyn is going to run up very very soon!
I highly doubt that!!!! Cytodyn scored on that. The drug is amzing, OLE's still making miracles and pretty soon the EUA. The whoe world will know about Cytodyn and the stock prices will break records too!
yes, they looked damn good!
Primary endpoint shows early clinical improvement in symptom score at Day 3 in patients receiving leronlimab
Leronlimab also demonstrated statistically significant improvement versus placebo in key secondary efficacy endpoint, National Early Warning Score 2 scale (NEWS2)
Results will be reported to the United States FDA, United Kingdom MHRA, and European Union regulatory agency, EMA
Management to hold conference call on August 12 at 1:00 pm PT - - details to follow
VANCOUVER, Washington, Aug. 11, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company announced today the Top-line results from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms. CytoDyn will submit its Top-line Report for this trial to the U.S. Food and Drug Administration for review later this week. The Top-line Report revealed the following information:
Clinical improvement assessed by change in total clinical symptom score:
In patients with Total Clinical Symptom Score of ≥ 4 at baseline (higher scores equate to poorer health state): At Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm vs. 71% on placebo). The subgroup analysis indicates that among patients with more symptoms at baseline, those who received leronlimab had a greater treatment effect than patients who received the placebo.
The National Early Warning Score 2 (NEWS2):
The National Early Warning Score (NEWS) is an objective scale developed by the Royal College of Physicians to identify patients at risk for rapid clinical deterioration requiring critical care intervention. NEWS2 (the latest version), is being used as an endpoint in several other COVID-19 clinical trials, including CytoDyn's severe-to-critical COVID-19 Phase 3 trial. It measures clinical parameters including respiratory rate, oxygen saturation, supplemental oxygen, temperature, systolic blood pressure, heart rate, and level of consciousness. In all treated patients, at the End of Treatment (or Day 14), patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group (50% vs 20%; p=0.0223).
Similar, statistically significant, results were observed at Day 3 and Day 14 in the analysis of per protocol population (p<0.03 and p<0.02, respectively).
Safety Endpoints:
The incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) were lower in the leronlimab group compared to the placebo group. Patients treated with placebo were more than twice as likely to experience SAEs or AEs compared to patients treated with leronlimab.
Harish Seethamraju, M.D., Lead Principal Investigator at Montefiore Medical Center NY, stated, “The results demonstrate that CCR5 blockade by leronlimab given as a weekly subcutaneous injection in mild-to-moderate COVID-19 patients is reasonably safe and associated with rapid improvement in viral symptoms with fewer adverse events than when compared to placebo.”
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “In the mild- to-moderate population, it is important to have a therapeutic option for COVID-19 in patients who are showing signs of rapid clinical deterioration. Patients receiving leronlimab showed a statistically significant improvement using NEWS2 clinical parameters. We will make a case for immediate approval of leronlimab for this population of COVID-19 patients, not only in the U.S., but in the U.K. and other countries around the world.”
Scott A. Kelly, M.D., Chief Medical Officer of CytoDyn, said, “We are thrilled with the results of leronlimab in mild-to-moderate COVID-19 patients. It is paramount to determine which patients will deteriorate and require critical care interventions, including patients at risk for ICU admission, cardiac arrest, or death within 24 hours. The NEWS2 aims to identify those patients most at risk. We are pleased that leronlimab showed a statistically significant result in a randomized, double-blinded study for NEWS2. The decreased probability in serious adverse events, as well as overall adverse events with leronlimab compared to placebo further supports the use of leronlimab as a treatment option for COVID-19.”
Jacob P. Lalezari, M.D., Senior Science Advisor to CytoDyn, said, "Treatment with leronlimab demonstrated reductions in both serious adverse events, as well as predictors of pulmonary collapse in patients with mild-to-moderate COVID-19. We initiated the study hoping to reduce flu-like symptoms, such as fever, cough, and muscle aches. In the end, use of leronlimab was not only correlated with improved symptom scores in patients with measurable symptoms at baseline, but also provided significant and consequential benefits on far more serious endpoints. Demonstrating these efficacy signals in a population with mostly mild illness at study entry bodes well for leronlimab’s activity in patients with more severe illness.”
About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. Enrollment continues in its Phase 3 randomized clinical trial for the severe-to-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 is believed to typically transmit person-to-person through respiratory droplets. 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.
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.
The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab for the prevention of GvHD.
Thank you for the reminder "“We are eager to reach conclusion in our discussions with all the regulatory agencies for the path going forward and will release the details of our data and the results of our discussions with regulatory agencies in the coming weeks.” Details of the Company’s ongoing discussions with the regulatory agencies are confidential." I smell victory for Leronlimab and CYDY $$$$$$$$$
And I'm guessing that the FDA, MHRA and other agencies are involved in this " scam"? The FDA is past reviewing Leronlimab and as stated in the PR, talk are being held. I guess we'll wait and see? We'll see who the winners are and who ( just a few) the losers will be. I know one thing thats a fact- Cytodyn is up over 300 percent YTD- not bad huh? Oh, another thing, institutions are buying in as well. Question for you, do you think that the large institutions buying in have not dome their due diligence?
The EIND's and the OLE's would have been stopped. The data is spectacular and the discussions are about logistics, labeling and importing from Samsung. Cytodyn is going to make history
I still feel there's a lot of behind the scene deals going on right now as to manufacturing and labeling, hence the delay. I still feel a partnership will be announced soon.
Run date is January 8th, they bought in on the 25th
Debunked
First hand capital management buys 322730 shares of Cytodyn, I wonder if they know something we don't. Is there an SEC law in place that allows companies to disclose information to certain investment groups? I can't see a purchase this large from a company that basically only invests in tech stocks.
Proof of failure???
I highly doubt that. This the catalysts being so many and a PR drop any day, I would seriously re evaluate your position. I have friends who legit shorted CYDY but have closed their positions with good reason.
Misiu, thank you! Your posts are always valued. Leronlimab is sure to be a hit in the medical field!!!
Any doctors on the board know if Leronlimab can also be used for Antiphospholipid syndrome?
I guess that the people who bought 322K shares at TEFQX must be amateurs. I'm wondering if they fall under the selective disclosure rule of the SEC and therefore invested in CYDY. They have analysts in house, i'm sure they know what they are doing. We're still up over 300 percent for the year no?
Check the facebook page, screenshot of the purchase of the CYDY stock on there. I don't know how to post it here, there's no link
LOL..yeah right, duped on a 305 percent gain???
Cytodyn is amazing and Nader will have the last laugh
huh, firsthand tech opportunities fund likes CYDY to the tune of 322K shares yesterday. Amazing huh?
Whatboutdat?
but but bit its up 305.53 percent in 1 yr! Cytodyn is well on it's way to being a record breaker, give it time.
So three week loss is not even something to talk about
LAUGHING like really hard at my gains so far
Did the flu vaccinations hurt the thera flu sales? Nope! 18 billion a year strong so I would say we're going to do great. Cytodyn is the next HUGE pharma co
I counted 21
Misiu, exciting is an understatement!!!!! Like Dr. Jay said the whole world will know about Leronlimab!!!
LOL..OK, 356 percent gains are nothing to be excited about. Like I said, see you at 20SP in the blink of an eye
ehhhh close but outdated.
Debunked again on the patent issue so let's not see that post again.
FYI, discussions with regulatory agencies is about as good as it gets.
Good luck to all longs, we've reach our goal just waiting for Nader to make it official
Here's the patent number with 2 digits missing, you'll have to do some DD.
Sure it's a use patent???
LOL
US71**185B2
lol...did the market close yet??? Down now but way up for power hour!!!
NOPE!!!! Better re read the entire document!
weeeeeeeeee
CYDY..up 356 percent in one year- amazing isn't it, that's a FACT!!!!
hahahahahahaha...you sure?????
CytoDyn reported in its form S-1 (February 2016), that it has 12 issued US patents and 27 issued international patents for leronlimab expires in 2031.
DEBUNKED once again- lets move on.
CYDY $$$$$$$$ Up 356 percent!
I sent this over to Nader, hopefully he can ship a few doses over! Obviously they know about Leronlimab and are asking for it!!!
Both! Info@incelldx.com for more details https://t.co/p86BovRy4L
— Bruce K. Patterson MD (@brucep13) February 24, 2021
There's no doubt in my mind that Nader is in talks with big pharma for a partnership. Did anyone read the FDA or the CDC release about different mab manufacturers teaming up? I read that a few days ago, can't remember where
So? When the positive news pops this stock will see record breaking gains with instant overnight sales in the billions. We have inventory thats all we need is the purchase order and Venmo Cytodyn the money and it's off to the moon! More importantly, lives will be saved
351.76 percent gain in one year is bad news? Huh? That's a huge gain, agree? CYDY will double that soon
I havent heard a word. I try to stay away from "talk". I study the science, and i'd say its incredible.