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Eravacycline Conference Call: Unrevealing and Disappointing

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Whatever has become of investigative journalism?  All we read after the Stifel conference call (11/17/2015) is descriptive rehash of information provided by Tetraphase at the conference.  No probing questions that we thought investors would ask who just lost 80% of their money.  No signs of analytical or strategic readjustment at Continue reading Eravacycline Conference Call: Unrevealing and Disappointing→

The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?

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Any FDA meeting is a high-stakes game for industry:  One never knows how the discussions will go. Some oddball issue may take center stage and usurp much time, creating an unbalanced perspective.  At other times, simple issues seem to create controversy, questions are not properly understood in the context of Continue reading The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?→

AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1

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Only now, a few days before the actual AMDAC meeting, the FDA’s Briefing Document becomes available to the public.  The topic of the December 5th meeting:  Reappraisal of the risk/benefit of fluoroquinolones (FQ) in approved but “mild, self-limiting” disease indications in light of new post-approval safety issues. The document is 617 Continue reading AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI  – Part 1→