Eli Lilly's COVID-19 Treatment Candidate Has a Manufacturing Site Problem
Eli Lilly's (NYSE: LLY) COVID-19 roller-coaster ride took a turn for the worse on Wednesday morning. According to Reuters, the FDA found quality-control issues last year at a site currently being used to manufacture LY-CoV555, a monoclonal antibody that attaches itself to the coronavirus responsible for COVID-19 before it can enter host cells and turn them into virus-replicating factories.
Following an inspection last November, the FDA found data regarding manufacturing processes that had been deleted without an appropriate audit from the company's quality-control unit. While these recently highlighted issues don't concern LY-CoV555 directly, they did result in an "Official Action Indicated" notice from the FDA that hasn't yet been resolved. As such, they could lead to a delay in LY-CoV555 receiving emergency use authorization because it was manufactured on the same site.
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Source Fool.com
