So I've read and re read all the blog updates from this year
And i notice that the 60 comments are comments made over the course of 5 years not just a meeting ago.
Our next IDE submission will be an amendment to the previous application. We are systematically preparing the answers to the 60 previous FDA comments over the last five years. Most of these have been addressed previously, but the members of the review team have changed. When we critiqued our responses, we felt it was worth the investment to redo a few studies to ensure that the FDA comments were fully addressed...
That's the problem with MK's failure to respond in a timely fashion and why FDA put Radiogel on slow track. Time kills all deals. Reviewers move on. New reviewers have new questions, etc. Not FDA's fault MK takes over a year to respond to their comments.
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