Ernest Marmer
Long only, special situations

EnteroMedics Device Faces FDA Panel June 17th With Weak Clinical Data

EnteroMedics (NASDAQ:ETRM) is developing a vagus-nerve stimulator to address obesity, and is facing a panel of medical experts Tuesday, June 17th, who will make recommendations about its Maestro device to the FDA for/against its approval for the US market. In recent years, ETRM has conducted two Phase III trials on the device, both of which clearly missed all their efficacy endpoints, resulting in the stock losing 97%+ of its price (from about $30 down to about $0.85). Yet, company PR, a small handful of analysts and some interpretations of recent stock action claim good reason for likelihood of approval nonetheless. A close and sober look at the clinical context is called for.

Phase-III trials' results and trial design...

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