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To: Jeff Chan who wrote (1823)	5/11/1999 11:45:00 PM
From: Pierre S.	Read Replies (1) of 14101

Thank you Jeff and Mark, not quite what I'm looking for but I appreciate your answers. My point is that the FDA looks at drug approval as a cost/benefit issue. I'm just trying to figure out how the FDA is looking at this one; "cant hurt and it might help a couple of people so we'll approve it" (like a Myoflex),or will they get nervous with DMSO. An example of this is Orthovisc made by Anika, a superior product when compared to available Synvisc to treat osteoarthritis of the knees. It was already lined up with a J/V and approved in Europe and Canada, but last october the FDA pulled the rug from under them on a study "technicality". I wonder if they would have been as strict if it had been a lotion as opposed to an intraarticular injection. I work a little bit in the drug development world so I know a few things about the FDA (but obviously not enough) and this particular transdermal system is in a class all of it's own. I guess we'll have to hang in there and wait. Sorry for the long explanation, your comments are always appreciated. Pierre

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