Cytodyn Inc (CYDY)

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I think it’s important to understand the rationale and impact of granting the open label extension

https://pubmed.ncbi.nlm.nih.gov/17253876/

I think there are ethical considerations on both sides, but I don’t think this is a situation where the FDA is trying to gather more post surveillance safety data on the therapeutic being evaluated. I’m convinced this is one of the few (although controversial) situations where the objective is to simply increase access to a therapy with clear/established mortality benefits. Giving access to new patients that don’t have 3 weeks to wait for EUA is compassionate and should be applauded