stock & financial message boards
  Joined Today: 14

  Login  |  Registration |  Site Map  |  Stock Market Blogs reaching thousands of users every day  |  Recent Activity  |    |

Next » | All Messages |  DDSS Message Board Home | recommend post |  Ignore Poster

Message #1
From: Jason
Date: June 29, 2007 06:43:10 AM

DDSS, Labopharm meets with FDA to discuss second Approvable Letter for once-daily tramadol

Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has met with the U.S. Food and Drug Administration (FDA) to discuss the matters raised in the Agency's May 30, 2007 Approvable Letter for the Company's once-daily formulation of tramadol. The Company believes that the meeting with the Agency was productive and that the statistical analysis required by the FDA to achieve approval has been clearly delineated. If the existing data cannot satisfy these statistical requirements, the Company would be required to generate new data through an additional Phase III clinical trial. Labopharm will provide additional updates as it continues to interact with the FDA, as well as work with its marketing partner for the U.S., Purdue Pharma, and its advisors.

About DDSS Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company has a robust pipeline of follow-on products in both pre-clinical and clinical development. For more information, please visit www.labopharm.com.

Next » | All Messages |  DDSS Message Board Home | Ignore Poster