Guest guest Posted February 5, 2004 Report Share Posted February 5, 2004 > Hi to surface Hippies: > > recently made reference to an upcoming meeting of the > Orthopaedic and Rehabilitation Devices Panel to review the > resurfacing device.. I have checked the FDA website and the planned > meetings for march have both been cancelled. Where do you see that, because on the meetings link of this page, they are still listed as proposed date?? http://www.fda.gov/cdrh/panel/ The next planned > meeting is not until June 3rd and June 4th. No details are yet > listed. A portion of each meeting is public permitting comments > from anyone interested. > > This meeting is part of the process to obtain the FDA PMA (Pre- > Market approval), which once obtained will negate all the insurance > company arguments about experimental/investigational. The FDA has > tried to complete the process in about 180 days. No official > information available ye but I will keep checking. The FDA is required by law to give an answer within 180 days. My information is that the clock started before Dec 9, 2003. June is too late. Its quite possible that the approval can be done without convening the advisory panel if they have gotten enough guidance previously (through the construction and approval of the IDE plan). If the March meetings are indeed cancelled, that could perhaps mean good news, not a delay. It seems to me that the company has all its ducks in a row, particularly with the publication of the pre-IDE results in a refereed journal and also with the development of the risk index which will help greatly with proper patient selection and surgeon education. Our next clue on this issue will come on Feb 12th when the company has scheduled a conference call with investment analysts. It will be on the www.wmt.com website that evening. - Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 5, 2004 Report Share Posted February 5, 2004 > > Hi to surface Hippies: > > > > recently made reference to an upcoming meeting of the > > Orthopaedic and Rehabilitation Devices Panel to review the > > resurfacing device.. I have checked the FDA website and the > planned > > meetings for march have both been cancelled. > > Where do you see that, because on the meetings link of this page, > they are still listed as proposed date?? > http://www.fda.gov/cdrh/panel/ > My mistake, the meeting I saw listed there in March was general surgery, not ortho. Since the meeting is early June, according to my calendar/date book its the 156th day of the year or about 178 days from Dec 9. Seems like its theoretically possible, I suppose, but I wonder if they would cut it that close. - Quote Link to comment Share on other sites More sharing options...
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