Plazomicin's BSI Indication Could Be First LPAD Drug – If Achaogen Can Convince US FDA Of Efficacy
Advisory committee will review applications for cUTI indication, which looks good, and the BSI indication, which looks fraught.
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Plazomicin's BSI Indication Gets 'No' From Advisory Panel, But US FDA Still Might Approve Under LPAD Pathway
Achaogen should at least be reassured by advisory committee's unanimous 'yes' vote for plazomicin's cUTI indication.