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Tag Archives: tolerability

Omissions – Commissions – Errors – Blunders – Solithromycin

Posted on January 12, 2017 by Harald — No Comments ↓

Cempra received a complete response letter (CRL) as a X-mas present from FDA, and the news was pretty bad for company investors. Bad, but not totally unexpected after the AMDAC meeting last November, which taught us a few new things about the drug. It also highlighted how strategic missteps can Continue reading Omissions – Commissions – Errors – Blunders – Solithromycin→

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Posted in QIDP Antibiotics, The News, The Viewpoint | Tagged Allphase Pharma Consulting, AMDAC, antibiotic blog, Aventis, CABP, Cempra, complete response letter, CRL, DILIsym, FDA, Harald Reinhart, hepatotoxicity, Ketek, ketolide, LFT, liver toxicity, NASH, non-alcoholic steatohepatitis, Sanofi, Solithera, solithromycin, telithromycin, tolerability | Leave a reply
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