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Re: Raggedy Man post# 12664

Friday, 04/02/2010 5:30:34 PM

Friday, April 02, 2010 5:30:34 PM

Post# of 59549
interesting links, thanks. Third party reviewers (i.e., FDA consultants) have been a route I've been suggesting for half a year...don't understand why they haven't done it other than possibly stubbornness on Dean's part. If it's cost, then it's being penny wise and pound foolish. And if the WSJ article is correct, now it may be too late to make use of 3rd party reviewers depending on what FDA decides about them.

On top of all that, it's the "FDA is re-evaluating its entire device-approval process" statement that totally wigs me out. This has the potential to turn into a cluster real quick, as if it hasn't been already. I'm hoping the main thing we have going for us now is the fact that DViS been on the FDA's docket for far too long now which doesn't ultimately reflect well on them...FDA may want to get them off their list just as badly as Dean and we do.