(RTTNews) – Biotechnology company CytoDyn Inc.(CYDY.OB) announced Monday that it had its main report on its recently completed randomized, double-blind Phase 2 trial for COVID-19 patients in the United States with moderate to moderate symptoms.U.S. Food and Drug Administration (FDA), and was implemented for emergency use authorization.
CytoDyn has also sent this outstanding report to the regulatory government in Mexico and hopes to obtain emergency use approval from MHRA in the UK, EMA in the European Union, as a government in Philippine regulations.
In parallel with previous activities, CytoDyn approached through several physicians about a clinical examination of leronlimab in individuals with coVID-19 long distance.
The Company is preparing a Phase 3 protocol and will register it as soon as possible.Recruitment continues in its randomized Phase 3 clinical trial for the severe COVID-19 population in several hospitals across the country.
The FDA has awarded a Fast Track designation to CytoDyn for two indications of leronlimab for serious illnesses.