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Biotech / Medical : Biotech & Pharma.T.A,

BIB 71.45

+2.8%

Nov 10 4:00 PM EST

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To: Jibacoa who wrote (2549)	1/22/2010 12:26:04 PM
From: Jibacoa	Read Replies (1) of 3722

SOMX has closed most of its January 2 DG.<g> The stock opened with a good UG and is still up 106% with volume > 19,955,700 close to 10x its ADV but still way below the 30.2M traded on Jan2 <g> bigcharts.marketwatch.com It provided yesterday an update on the status of its NDA of Silenor(doxepin) for the treatment of insomnia. SOMX said that it held a meeting with senior leadership at the FDA on Jan20 to discuss the issues raised by the FDA in Dec relating to the Silenor NDA. The only remaining efficacy issue was related to the robustness of sustained subjective sleep maintenance efficacy in non-elderly adults with primary insomnia. In the meeting on Wednesday, the FDA and SOMX discussed this issue, and the FDA instructed SOMX to resubmit the contents of its pre-meeting briefing package and it acknowledged that this resubmission would be considered a complete response to its letter in Dec.<g> The FDA also agreed that this would be considered a Class 1 resubmission with a two-month review cycle. No additional safety or efficacy data was required to be included in the resubmission, and the company filed the resubmission with the FDA yesterday. As a result, it anticipates a decision from the FDA by March 21. In the meeting the FDA also reiterated that a revised Risk Evaluation and Mitigation Strategy (REMS), including a Medication Guide to be distributed with the product, will be required. It seems that with some good news the stock could get back to the $5 level.<g> bigcharts.marketwatch.com Bernard

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