To: David Graham who wrote (6952 ) 3/15/2001 7:48:01 PM From: john.d Respond to of 14101 David, "My choice would be to offload production to a contract manufacturer who already has a facility in place in or near the desired markets. DMX's valued added should be in the continued development of marketable drugs, not the production thereof. Management has only so much time to devote to any project, and overseeing production seems like a small source of value added. As well, the whole theory of DMX owning and operating a bunch of manufacturing facilities runs counter to the general concept of specialization and I can't see a reason to justify it." one year ago, I would have agreed with you, but after listening to Rebecca's rationale for not contracting out the work, I fully support her strategy. She argued that, when you contract out the manufacturing, you have to teach a potential future competitor how to make your product. Come 2006 the patent expires on Pennsaid, and we are at risk of having others produce generic products. A patent document outlines only general issues, it does tell the reader every last detailed they need to know to manufacture a product perfectly. A contract manufacturing agreement on the other hand, would require you to share all the trade secrets that you have developed in perfecting the process over the years. Why make it any easier for them to produce Pennsaid and take market share away from you when the patent expires in 2006. As I understand it, it's an issue about protecting the intellectual property of your flagship product and NOT about margins on manufacturing. She also mentioned that they tried the route of using contract manufacturing and ran into nothing but trouble. Pennsaid was simpy not as important to the contract manufacturer as it is to Dimethaid. As I understand it, Dimethaid had little choice but to purchase the plant in Quebec, because the contract manufacturer could NOT be counted on to do whatever it would take to ensure that the FDA and other regulatory bodies were totally and completely satisfied. This change in plants has contributed to the delays we are experiencing with FDA approval. Rebecca also noted at the AGM that Oxo was having some difficulties with their contractor on the phase III trials for WF10. I think we can expect to see Dimethaid Pharmaceuticals (OXo and Dimethaid) set up a manufacturing facility to produce WF10, if and when it is approved. I'll bet on it. John