The Clinical Trials Unit of the Medicines & Health
Post# of 155670
(Total Views: 761)
Posted On: 08/20/2020 6:58:40 AM
Quote:
The Clinical Trials Unit of the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government authorized the Company to enroll for its ongoing Phase 3 COVID-19 trial for severe-to-critical patients in the United Kingdom. The MHRA’s decision follows several months of its review of CytoDyn’s manufacturing processes and leronlimab’s safety profile.
This is very good news. I think will not affect us for the pre-interim timing but certainly, if there is need to continue enrolling, will mean much faster completion of CD12 trial.
I hope hospitals in U.K. are already being given training, documentation and Leronlimab so they can stat enrolling ASAP.
Additional benefit: once approved in the USA the U.K. will follow immediately as they are now involved and participating.
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