EnteroMedics Inc (NASDAQ:ETRM) Discloses Its Date With FDA On Its 4Q Earnings Call


Dallas, Texas 02/21/2014 (FINANCIALSTRENDS) – The $145 million market capped medical equipment and appliances maker EnteroMedics Inc (NASDAQ:ETRM) had a action packed day on 12th February. It started the day with an announcement which set the date for the review meet with the Advisory committee set up by the Food and Drug Administration and followed it up with the release of its 4Q and Full year operation results.

The review meeting is slated for 29th May of this year, and is related to its proprietary drug Maestro(R) which is a mechanism to help patients treat Obesity. It is important to note here that the advisory committee set up by FDA, is a board constituted of individual members belonging to the clinical and scientific community and are mandated to advise the FDA on various aspects of the clinical devise being tested for approval. The committee recommendations will only serve as guideline to FDA and is not binding on the drug approval authority.

Expressing his happiness at the quick progress towards a review meet with the select committee, EnteroMedics Inc (NASDAQ:ETRM) President and Chief Executive Officer Mark B. Knudson, Ph.D. has been quoted to have said that, “We are pleased that the FDA has decided to move the PMA application for our innovative technology forward towards possible approval by scheduling an Advisory panel meeting to discuss the Maestro System. We very much look forward to presenting VBLOC Therapy to the panel members as we work to address the significant and widening gap in treatment alternatives for obesity and its associated diseases,”

The firm also reported its 4Q and Fy13 full year operation results on the same day. It reported accumulating net loss of $25.8 million from the year’s operations which tapered down to $6.6 million loss for the 4Q. Form its full year operations, the drug firm had accumulated close to $23.3 million in cash and cash equivalents.

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