We do not know the whole story. Andrew did tip his hand when he apparently said: "I'm the culprit on that..." referring to the application and going through three consulting firms, but if the FDA wanted to expedite this technology, they would find a way to do it. And yes, there has been reorganization at FDA, especially in the medical device area. If I can find the link from Sept./Oct I will post it.
So, I do not believe its all biel's fault, just more than half.
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