Eravacycline Conference Call: Unrevealing and Disappointing

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

Ibuprofen For uUTI: Interesting Pilot Trial But More to Come Soon

At the recent AMDAC, the frequent mention of an unusual uUTI study caught my attention.  In their review of placebo-controlled trials, FDA mentioned a study comparing ciprofloxacin with Ibuprofen (Motrin), an NSAID drug without any antibacterial activity[1].  By the outcome of total symptom relief, there was no difference. Obviously, there Continue reading Ibuprofen For uUTI: Interesting Pilot Trial But More to Come Soon

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

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?