Catalyst
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Cempra to Present Solithromycin at FDA Antimicrobial Drugs Advisory Committee Meeting on November 4, 2016
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Additional Information
Cempra conducted two pivotal Phase 3 global registration trials of solithromycin. The first study was conducted with solithromycin oral capsules, and the second study tested intravenous (IV) solithromycin progressing to oral solithromycin. Both Phase 3 studies met their primary endpoints that were aligned with FDA guidance.Solithromycin was granted qualified infectious diseases product (QIDP) designation which entitled the new drug applications (NDAs) to eight month priority reviews, resulting in PDUFA dates of December 27, and December 28, 2016, respectively, the oral and intravenous NDAs.
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Catalyst Date
Occurred on:
Nov 07, 2016
Occurred Source:
http://investor.cempra.com/confirm.cfm?destination=/releasedetail.cfm&addFile=916048&wshRemove=yes&ReleaseID=997840
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Related Keywords
Solithromycin, Antimicrobial, Ad Comm, Cabp, Community Acquired Bacterial Pneumonia
