Keith Rettig's Comments RSS Syndication from SeekingAlpha.com http://seekingalpha.comuser/71055/comments http://seekingalpha.com/article/32444-clarifying-the-issues-surrounding-dendreon-s-provenge?source=feed#comment-84365 84365 Mon, 16 Apr 2007 13:06:34 -0400 http://seekingalpha.com/article/31840-dendreon-don-t-forget-about-risk-vs-reward?source=feed#comment-83873 83873 It was then that the panel chair asked the FDA for clarification. The FDA clarified that they wanted to know "if the data provided substantial evidence". This is not changing the question; this is defining what they meant.
I was quite impressed with how this played out. It clearly shows that the CBER panel is thinking of the patients as well as the quality of the product; and thus performing exactly as the FDA wants them.
I strongly agree with 'echo toall' regarding that this would seem to indicate the FDA's intentions for approval.]]> Tue, 10 Apr 2007 10:02:44 -0400 It was then that the panel chair asked the FDA for clarification. The FDA clarified that they wanted to know "if the data provided substantial evidence". This is not changing the question; this is defining what they meant.
I was quite impressed with how this played out. It clearly shows that the CBER panel is thinking of the patients as well as the quality of the product; and thus performing exactly as the FDA wants them.
I strongly agree with 'echo toall' regarding that this would seem to indicate the FDA's intentions for approval.]]>