Guest guest Posted May 6, 2004 Report Share Posted May 6, 2004 thank you so much for the update. do you know anything about the Corin trial and its status? i've tried contacting Batts, who used to be somewhat " present " on this board, but to no avail.... maureen jacobs, rhip, 10.31.02, corin Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 25, 2004 Report Share Posted June 25, 2004 The FDA Orthopedic Devices Panel Meeting proposed for August has been cancelled. The next proposed meeting dates are Dec 2-3, 2004. If the panel considers the ConservePlus then, the earliest it might actually be approved would be Jan-Feb of 2005. The minutes from the June meeting are on their website. On June 3rd, in the afternoon they considered a guidance document prepared by an industry group regarding the structuring of future clinical trials. I have not had a chance to read all the minutes but from what I have seen so far, they seem cool to the idea of reducing the standard follow-up time before review to one year from two. This doesn't directly affect the Conserve+ or Corin trials since they are already underway, but one can get some flavor of what the panelists might be looking for from the trial data when they review it. Here is the link. http://www.fda.gov/ohrms/dockets/ac/04/transcripts/2004-4049t2.htm Quote Link to comment Share on other sites More sharing options...
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