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" ... An FDA spokesperson responded to my request for comment by email, writing that "CDRH accepts in vitro testing to assess the cytotoxicity and acute systemic toxicity potential of personal lubricants. Regarding vaginal irritation and sensitization, at this time, we are not aware of any validated in vitro models for those tests." ... "
" ... The VIR-7832 antibody additionally contains an Fc GAALIE mutation shown to boost T-cell immunity. GAALIE is an acronym for the amino acid mutations in the Fc region, specifically G236A, A330L, and I332E. These mutations would enable antibody-dependent complement-mediated cytotoxicity without inducing antibody-dependent enhancement. In other words, it would neutralize the virus and clear out infected cells faster. ... "