Cytodyn Inc (CYDY)

[masshysteria]

That is wrong and for all the oppo research you do - stating ANVISA did not approve Leronlimab for use in COVID clinical trials is misleading readers of this board. It can also cause potential family applicants for the trial to second guess themselves and cost them their lives.

The page you sent only references those products that have already been approved or authorized for emergency access. It only references clinical research as an effort without detailing the products under clinical use.

And, by the way, the word NO in Portuguese is spelled NAO.

The word NO in Portuguese actually translates to 'AT THE' in English

This is what ANVISA said about Leronlimab:

Anvisa authorized, on Monday (2/8), the realization of the clinical study to evaluate the safety and efficacy of the drug leronlimab for the treatment of moderately ill patients with pneumonia caused by Covid-19. Leronlimab is a monoclonal antibody that acts as a competitive inhibitor, blocking cell infection.

This is a phase 3, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of leronlimab in combination with standard care for patients hospitalized with Covid-19 pneumonia who do not require mechanical ventilation. or extracorporeal membrane oxygenation.

The study is sponsored by CytoDyn Inc., headquartered in the United States and represented by Biomm S.A. in Brazil. The research will be conducted by the Sociedade Beneficente Israelita Hospital Albert Einstein, in São Paulo.

Another clinical study protocol for Leronlimab, referring to patients who, in this case, require mechanical ventilation or extracorporeal membrane oxygenation, is still under analysis of compliance with the requirement.

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This is what ANVISA said about general medicinal access for COVID.

MEDICINES

So far, there are three drugs with an indication approved by Anvisa for the treatment of Covid-19 in Brazil, one of them – Rendesivir – registered and the other two in emergency use.

AUTHORIZED/APPROVED REGISTRATION:

render

AUTHORIZED EMERGENCY USE:

Association of monoclonal antibodies casirivimab and imdevimab.

Association of banlanivimab and etesevimab antibodies.

AUTHORIZATION REQUESTS FOR EMERGENCY USE:

Tofacitinib

Sotrovimab

Regdanvimab

RESEARCH IN DEVELOPMENT:

Anvisa has authorized more than 100 clinical studies of drugs and vaccines against Covid-19, both new products and products that are already authorized for use against other diseases.

The progress of each research is the responsibility of each sponsoring laboratory.

As these substances are still in the research phase, it is not possible to detail the way in which these products work and use, since their application to confront Covid has not yet been evaluated by the Agency.