Cempra (CEMP) Shares Halted Ahead of FDA AdCom on Solithromycin as CABP Treatment
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Cempra, Inc. (Nasdaq: CEMP) announced that NASDAQ has halted trading of the company's common stock.
The U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) is meeting today to discuss the safety and efficacy of solithromycin to treat community-acquired bacterial pneumonia (CABP).
The Advisory Committee meeting is scheduled to begin at 8:30 a.m. ET and is scheduled to end at 5:00 p.m. ET. The FDA briefing materials for the meeting can be found at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/ucm496389.htm.
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, for the oral and intravenous NDAs.
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