Wednesday, April 09, 2008 12:26:27 PM
I'm not sure why you are posting this gibberish because it is clearly biased and vague at best. A well written post on the ODAC meeting must back up the opinion with quotes or a least paraphrase a section that you are referring to. Anybody can pull out pieces that were later clarified. Anybody who thinks that an FDA meeting is a simple discussion is being foolish. The fact that your poster doesn't even mention the real issues the committee had, tells me that they didn't read the transcript and in fact, the link is to the briefing docs and NOT the meeting transcript.
The biggest problem the committee had was whether or not there was a qualitative or quantitative interaction between infosfamide and L-MTP-PE. The COG recently put this matter to rest in their JCO publication by stating that there was NO interaction between the two.
The other big problem was whether the four arms should be analyzed individually or pooled into MTP and No MTP groups. The JCO publication addressed this as well.
The dataset issue is obvious to all that have followed IDM and clearly the 2003 dataset was sloppy. The 2006 dataset was submitted too late to be considered and the 2008 dataset will be as clean as it gets. You need to realize that a lot has changed since last year and that the main issues have or are being addressed and None of these issues can distort the fact that L-MTP-PE significantly improves your odds of surviving Osteosarcoma. Your post doesn't even mention the current climate and the recent COG opinion because this would be very counter-productive to their argument.
Oh and the cutesy quote from the non-binding shows more than anything what the intentions of this poster are. And the provenge comparison makes no sense and isn't even something to discuss.
Sorry Mex but that post wasn't even worth this much of a reply.
The biggest problem the committee had was whether or not there was a qualitative or quantitative interaction between infosfamide and L-MTP-PE. The COG recently put this matter to rest in their JCO publication by stating that there was NO interaction between the two.
The other big problem was whether the four arms should be analyzed individually or pooled into MTP and No MTP groups. The JCO publication addressed this as well.
The dataset issue is obvious to all that have followed IDM and clearly the 2003 dataset was sloppy. The 2006 dataset was submitted too late to be considered and the 2008 dataset will be as clean as it gets. You need to realize that a lot has changed since last year and that the main issues have or are being addressed and None of these issues can distort the fact that L-MTP-PE significantly improves your odds of surviving Osteosarcoma. Your post doesn't even mention the current climate and the recent COG opinion because this would be very counter-productive to their argument.
Oh and the cutesy quote from the non-binding shows more than anything what the intentions of this poster are. And the provenge comparison makes no sense and isn't even something to discuss.
Sorry Mex but that post wasn't even worth this much of a reply.
