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Friday, August 21, 2020 8:51:55 AM
Announced today 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.
The more I think about this, they more I feel the company is making progress, this isn't fluff. A small unknown biotech company in the US was permitted to test patients in another country, on their people. The UK must have seen how safe and effective Leronlimab is to allow this. We're not a big pharma with millions to lobby officials around the world, the science got our foot in the door.
Second part is the FDA is allowing us to use these patients to further our phase 3 trial. So we made strides with both the UK government and the FDA.
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