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Great article.
https://www.frontiersin.org/articles/10.3389/fimmu.2021.816515/full
The drug Leronlimab is a humanized anti-CCR5 IgG4 monoclonal antibody that is delivered subcutaneously or intravenously (Table 1) (115). Preliminary studies have shown that contrary to natural antibodies, Leronlimab is able to bind the N-terminal domain of EL2 on the CCR5 receptor, the same binding site used by gp120 (Figure 2). This loop is thought to be a well conserved area of CCR5 encoding genes (108).
Studies in rhesus macaques showed dose-dependent protection from CCR5-utilizing infection following injections of Leronlimab subcutaneously. Additionally, 50 mg/kg prevented HIV-1 infection in all sites for all subjects, while just 10 mg/kg prevented infection in rectal tissue in all but one subject (117). In Phase 2 clinical trials in individuals with solely CCR5-utilizing HIV-1 intravenous Leronlimab infusion was well tolerated. Dosage as low as 5 mg/kg elicited maximum antiviral effects around 14 days post injection with greater than 1.8 log viral load reduction (118). In this same study, viral load rebounded to near baseline in all dosages around day 40 post-injection, highlighting a need for sustained treatment. No evidence of resistance or switched tropism was observed while only mild side effects were encountered with this medication, and it has been given a fast track status by the US Food and Drug Administration (FDA) (119).
Of the monoclonal antibodies directed at CCR5 that have been investigated, Leronlimab has achieved the most sustained receptor occupancy.
It’s not a rumor!
Because Plaintiffs have not succeeded on the merits of their claim, their request for declaratory and permanent, mandatory injunctive relief must be DENIED. Final judgment is entered for Defendants.
IT IS SO ORDERED.
https://courts.delaware.gov/Opinions/Download.aspx?id=325470
New investor relations (from ymb)
Morrow Sodali, the global shareholder engagement and governance consulting firm, announced that it had been ranked #1 among proxy solicitors in U.S M&A transactions for the first quarter of 2021 by The Deal, continuing the firm’s #1 ranking for the full year 2020 and up from the firm’s #3 position in the first quarter of 2020. In addition, Morrow Sodali climbed to the #2 position among proxy solicitors acting for corporate clients in activism situations in 2020, moving up from the #4 position in Refinitiv’s Global Shareholder Activism Scorecard announced last month.
VERY INTERESTING!
See press release from today.
https://morrowsodali.com/
But…but….dreamcatchers….
Lol.
World Antiviral Congress
WAC Day 1 - 30th Nov @ 14:55
Leronlimab – a platform mab CCR5 antagonist and its role in antiviral indications
Scott Kelly, CMO, CytoDyn, Inc.
https://www.terrapinn.com/conference/world-antiviral-congress/speaker-scott-KELLY.stm
If this isn’t a NUKE - I don’t know what is…
https://www.sec.gov/Archives/edgar/data/0001175680/000119312521232225/d148969dex991.htm
Wow
Who are these posters? Tell us more about your links to past management.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=154651161
Wow. We have a anxious bunch here tonight….
Can you feel it?
Did I just hear that correctly from Dr Kelly?
23 indications. Each one valued at 8.3 billion.
So…
23 x 8.3 Billion = 190,900,000,000 Billion
Not bad ;)
Another job posting. Director/Sr. Director Regulatory Affairs (CMC)
Knowledge of US and EU Biologics, and Device Development (21 CFR Parts 3, 4, and 800) and Approval process.
Knowledge of Regulations, guidance, and procedures applicable to FDA, EMA, MHRA and other international regulatory agencies.
Maintains current knowledge of regulations and guidelines (FDA, EMA, ICH, PMDA and others, as required) to support the development and authorship of communications such as regulatory meeting packages, communications with regulatory agencies worldwide, preparation of INDs, CTAs, BLAs, annual reports and supplements.
Check out this job from CytoDyn
https://www.linkedin.com/jobs/view/2559019479/
Operations update
https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02377707-6A1034150?access_token=83ff96335c2d45a094df02a206a39ff4
Keep your eyes on the prize.
https://www.sec.gov/Archives/edgar/data/0001175680/000119312521163831/d185044d8k.htm
Effective May 11, 2021, CytoDyn Inc. (the “Company”) entered into an Exclusive Supply and Distribution Agreement with Macleods Pharmaceuticals Ltd., an Indian corporation, which is a vertically integrated, global pharmaceutical company (“Macleods”), pursuant to which the Company granted Macleods the exclusive right to distribute and sell up to 200,000 vials in calendar year 2021 of the Company’s product Vyrologix™ (leronlimab), to treat COVID-19 patients in India under Compassionate Special Permits (“CSP”) or Emergency Use Authorization (“EUA”) from the India Central Drugs Standard Control Organization (“CDSCO”).
It’s a WILD ride!
In case anyone is wondering…
Ranked #1 hospital in Brazil
1 Hospital Israelita Albert Einstein
https://www.newsweek.com/best-hospitals-2021/brazil
Goldman Goes All-In Commodities, Sees "Biggest Jump In Oil Demand Ever" Over Next 6 Months
https://www.zerohedge.com/markets/goldman-goes-all-commodities-sees-biggest-jump-oil-demand-ever-over-next-6-months
That is the new wonder drug that was given to my father.
— JV Ejercito (@jvejercito) April 26, 2021
Ex-Pres. Estrada leaves hospital after COVID-19 battle
https://news.abs-cbn.com/news/04/26/21/joseph-estrada-erap-discharged-covid-19
Wow. ;)
https://twitter.com/GA_born_bred/status/1385726639896662019?s=20
‘...we do know that many in the trial are feeling better.’
https://www.congress.gov.ph/press/details.php?pressid=12048
‘Meanwhile, some lawmakers lamented the unnecessary delay in the approval of Ivermectin and Leronlimab for use in treating COVID-19, as well as the lack of supply of Midazolam, Tocilizumab and other repurposed drugs for the treatment of the coronavirus disease.‘
Quote:
Leronlimab saves another life.
———————————————
You can't say that unless you are willing to say that "leronlimab kills another patient" every time a patient dosed with leronlimab passes away. The trials indicate that leronlimab does not save lives. Mr Estrada probably would have been fine without leronlimab.
———————————————
‘Everything else is just noise’
-NP
Former senator Jinggoy Estrada on Friday said the condition of former president Joseph Estrada continues to improve.
In a medical bulletin Jinggoy shared, he said that the chest- x-ray of the former president showed significant improvement and his oxygen requirement is at minimal levels.
“He is now on oral diet. We are praying that he can be discharged from the hospital soon. I wish to once again thank everyone for the overwhelming support for my father and our family. Thank you so much,” Jinggoy added
https://tribune.net.ph/index.php/2021/04/23/eraps-condition-continues-to-improve-jinggoy/
https://www.rappler.com/nation/joseph-erap-estrada-out-hospital-icu-april-19-2021
‘Everything else is just noise’
- NP
Just gonna leave this here...
Lucio C. Tan Sr. is a Filipino billionaire businessman and educator with interests in banking, airline, liquor, tobacco, real estate industries, beverages, and education. In 2013, Forbes magazine listed him as the second richest billionaire from the Philippines with a net worth of $7.5 billion.
Tan, 86, is the chairman and chief executive officer of LT Group, MacroAsia Corporation, and PAL Holdings, the parent company of flag carrier Philippine Airlines.
Filipino billionaire Lucio Tan has been hospitalized due to COVID-19, his daughter Vivienne Tan confirmed late Saturday evening, April 17.
"He is in stable condition, responding well, and recovering," said Vivienne in an Instagram post.
"We would like to request for some privacy at this time. Please continue to pray for his speedy recovery. Thank you."
https://www.rappler.com/business/lucio-tan-hospitalized-covid-19-april-2021
10 Signs Your Company is About to be Acquired
https://www.griproom.com/fun/10-signs-your-company-is-about-to-be-acquired
Discuss...
ERAP: COVID Free - Continues to improve
Former President Joseph “Erap” Estrada is now COVID-19 free, his son ex-Senator Jinggoy Estrada announced today.
“We are happy to announce that my dad continues to improve and we expect that he can be transferred to a regular room soon,” Jinggoy said in an online statement.
https://www.facebook.com/319488142121/posts/april-13-2021-1115am7-medical-bulletin-of-fmr-pres-joseph-ejercito-estradawe-are/10159425010987122/
https://ph.news.yahoo.com/former-president-erap-estrada-tests-043210237.html
BRAZIL'S brutal Covid-19 plague has been branded a "biological Fukushima" by worried scientists after daily deaths surged past the 4,000 mark.
Hospitals are now at breaking point with people dropping dead as they await treatment amid the rise of super-mutant strains which "threaten" the global fight against the virus.
https://www.reuters.com/article/us-health-coronavirus-brazil-idUSKBN2BT30P
Director of Regulatory Affairs - Cytodyn
:)
Job Description Summary
The Director of Regulatory Affairs is accountable for the successful global and regional execution of regulatory submissions both CMC and Clinical Development.
Following experience required:
Experience with designing and executing creative development strategies for Regulatory CMC and Clinical Development programs.
Experience with submissions of successful BLA and/or NDA.
Experience with FDA and other Health Authority audits and inspections.
Comprehensive understanding of FDA regulations and ICH guidances, as well as comprehensive experience in the drug development process.
Experience preparing and overseeing regulatory submissions, including INDs/Clinical Trial Applications and Marketing Applications in electronic Common Technical Document format.
Ph.D. or Pharm. D. or a scientific discipline or equivalent is preferred with minimum of 7 years experience.
Bachelors or Master’s Degree will be considered with relevant experience of 10 or more years in Regulatory Affairs.
Check out this job from CytoDyn
https://www.linkedin.com/jobs/view/2478347241/
FULL ENROLLMENT: Covid19 Long Hauler Clinic -AARDS Dr Gaylis Norman
@Aardslonghauler
Enrollment is FULL but due to the demand and response will have a extension and new study. If you are interested in participating in this study please call us (305) 405-1590 to join our waiting list or visit our website to sign up online!
https://twitter.com/Aardslonghauler/status/1377355825887338496?s=20
What are Significantly Regulated Organizations (SROs)?
HHS Supplemental Standards of Ethical Conduct formally defines SRO as "an organization for which the sales of products regulated by the Food and Drug Administration (FDA) constitute ten percent or more of annual gross sales in the organization's previous fiscal year; where an organization does not have a record of sales of FDA-regulated products, it will be deemed to be significantly regulated if its operations are predominately in fields regulated by FDA, or if its research, development, or other business activities are reasonably expected to result in the development of products that are regulated by FDA." See 5 C.F.R. § 5501.101(c)(2).
https://www.fda.gov/about-fda/ethics/prohibited-financial-interests-fda-employees
Note the webpage title: Prohibited Financial Interests for FDA Employees
https://www.accessdata.fda.gov/scripts/SDA/sdDetailNavigation.cfm?sd=srolist&id=BE259358DEF51F10E0530D98C30A47E8&rownum=1
SRO List - Detail
Print Share E-mail
FDA HomeSRO ListDetail
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Return to Listing
DUNS NUMBER: 132214508
BUSINESS NAME: Cytodyn Operations Inc.
COUNTRY NAME: USA
TICKER SYMBOL: CYDY
EXCHANGE NAME: OTHER OTC Market
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Page Last Updated: 03/19/2021
CytoDyn’s Smoking Gun For an Immediate EUA
https://insiderfinancial.com/cytodyns-smoking-gun-for-an-immediate-eua/181182/
The scientific (main) focus should have always been about developing and approving effective therapeutics for COVID-19. And it should continue to remain about providing effective therapeutic options for patients.
Start at 57 minutes....
https://thehighwire.com/videos/vaccine-disaster-ahead/
Very important to understand
The FDA updated guidance today (originally released in May 2020) entitled ‘COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry’.
The guidance states the following:
‘FDA strongly discourages disseminating data from ongoing trials. Knowledge of accumulating data by trial investigators and patients can adversely affect patient accrual, adherence, and retention, as well as endpoint assessment, compromising the ability of the trial to reliably achieve its objective in a timely manner.25 Issues with trial conduct caused by knowledge of interim results are difficult to predict and generally impossible to adjust for in statistical analyses. Therefore, releasing interim results could have ramifications on the integrity of the ongoing trial and the ability to collect reliable and interpretable data needed to support regulatory decision-making. If sponsors intend to conduct interim analyses, FDA recommends they consult the guidance for industry Adaptive Designs for Clinical Trials of Drugs and Biologics, prospectively plan these analyses, and incorporate processes to maintain the integrity of the trial (e.g., using an independent DMC). FDA recognizes there may be exceptional circumstances in which a sponsor determines it needs to disseminate results for safety or other reasons. In such situations, the sponsor is strongly encouraged to discuss with FDA before releasing such results’
https://www.fda.gov/media/137926/download
It’s available for all to read.
Longhaulers: More news
COVID-19 Long Hauler Hopes to Benefit From Local Trial
Eli Musser traveled from New York to South Florida to participate in a trial for the drug Leronlimab, a monoclonal antibody
"This is the first and only monoclonal antibody that has been approved for a study to evaluate the benefit Leronlimab may have for long haulers syndrome," Dr. Gaylis said.
https://www.nbcmiami.com/news/local/covid-19-long-hauler-hopes-to-benefit-from-local-trial/2385419/
What is Leronlimab?
New video
‘This [leronlimab] appears to stop the virus [coronavirus] from multiplying”
https://twitter.com/Aardslonghauler/status/1362073142647271425?s=20
‘Leronlimab appears to PREVENT COVID-19’
https://twitter.com/Aardslonghauler/status/1362011430791356417?s=20
I didn’t say it...they did.
http://www.rheum-care.com/
Maybe this will help.....
Covid19 Long Hauler Clinic -AARDS Dr Gaylis Norman
@Aardslonghauler
How is AARDS Long Hauler Covid-19 Clinic helping patients with Long Hauler symptoms?
https://twitter.com/Aardslonghauler/status/1361391691513618433?s=20
Not sure this was posted yet. But here you go. Enjoy!