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To: Pierre S. who wrote (1814)	5/11/1999 7:18:00 AM
From: Jeff Chan	Read Replies (1) of 14101

Hi Pierre... I think Mark pretty well answered most of your questions. Here's some other points. But will it pass FDA ? One can never really know until one sees it in black and white. I am trying to compare it to the only topical NSAID/analgesic I know the FDA has approved which is a Bayer product called Myoflex.I have used it on a few people and it appears to works as well as a placebo. You'd be surprised...many of the especially the older products are only as good as or slightly better than placebo. Diclofenac which is the active non-steroidal anti-inflammatory in Pennsaid has been around for quite some time. The question is not whether diclofenac works but whether the vehicle that DMX has is able to allow transdermal delivery of the drug and whether this process works and is safe. Where the same studies required, what was there sample size in phase3, will Pennsaid be judged the same way ? The same type of studies are required by any company applying for a new drug submission. I can't speak for the FDA, but certainly at the Health Canada website, the Health Protection Branch actually provides a template for all manufacturers of data that is required and how it is to be presented. Hope this helps. Jeff C

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