Guest guest Posted February 26, 2003 Report Share Posted February 26, 2003 In a message dated 2/26/2003 9:16:23 PM Central Standard Time, surfacehippy@... writes: > > Why not call Technologies directly: . Ask for > Churnetz (or something like that). I talked to him a couple years ago > before my surgery, and he was very accomodating. He handles (or then > handled) all the paperwork and approval stuff for their clinical trials. > From: > davidrad01 To: > surfacehippy@...: Wed, 26 Feb 2003 20:53:50 -0000Subject: > Re: How close is FDA approval on Conserve plusThe FDA can > not comment on anything regarding the trials. However, and Corin > could release information in a public statement if they chose to do > so.Perhaps we surface hippies could send them individual emails or letters > asking them to make some kind of " forward looking statement " on the > subject. Broder & gt; My > understanding is that the earliest would be spring of 2004. About a year > away. This is following standard procedure of getting two years of > following up from the clinical trial patients before submitting an > application late in 2003, then giving the FDA some time to respond. They of > course have longer follow-up data for the " pre-trial " patients. That is for > the Conserve Plus. I don't know where Corin is with their trial. & > gt; & gt; There was some talk that might appeal to the FDA for > approval of the C+ earlier on the basis of the unusual fact that each > individual component is now approved, and only the combination of the two > is not. & gt; & gt; Only Martha knows for sure what will happen... & gt; > & gt; - & gt; & gt; & gt; & gt; & gt; From: " bluecan123002 " & gt; & gt; Date: > 2003/02/26 Wed PM 01:01:29 EST & gt; & gt; To: surfacehippy & > gt; & gt; Subject: How close is FDA approval on Conserve plus & > gt; & gt; & gt; & gt; Does anyone know how close FDA is to approving Conserve > Plus? Humana & gt; & gt; will not approve hip resurfacing, because it is & > gt; & gt; experimental,investigational or for research purposes. If approval > is & gt; & gt; close maybe I can hold out longer. I was caught up in the Fda > & gt; & gt; stoppage of resurfacing last summer . Changed Ins. co. and now > has & gt; & gt; been denied. Any Ideas???? If I go to out of contry and pay > myself, & gt; & gt; will ins co pay for any complictions? Hopefully nothing > would & gt; & gt; happen. But you never know. Thanks & gt; & gt; & gt; & gt; & > gt; & gt; & gt; & gt; Quote Link to comment Share on other sites More sharing options...
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