Once the FDA gets "THEIR" act together???? I used to think (wish) that was the case, until the release of the NSE letter. I was lead to believe for a long time that the incompetent Govt Agency was surely at fault, and the stereo types of the whole office sitting around eating donuts, with files stacked up everywhere was how it was perceived.
All we needed was the radiologist reviews, and some silly labeling / format issues, and we were home free. This was the furthest thing from the truth, so the FDA isn't on the hook for this one. We waited three months for radiologist's review of images that weren't even performed live by the DVIS, and taken off a Web Site??? Are you freaking kidding me??
It was perfectly clear that Dean and his partners were absolutely livid when that NSE letter was released for all to see. Now I ask all here with any common sense, if the information contained in the NSE letter was truly what Dean reported it was in his last CC, why would he have one ounce of concern if it was released?? I heard him say multiple times how angry and upset he was that he didn't get SE clearance, and didn't understand why. Lots of talk about financials not being included, because they weren't asked for.
Make no mistake about it...Dean was infuriated that NSE letter was released. If he told the truth in the first place about it's contents, why would he care who saw it? The only reason to get angry about the letter being released, is if you are trying to hide something, which obviously was the case here. I honestly don't believe the Harbor Statement (if that's what it's called) is enough to protect Dean in this case.
Dean was asked DIRECT questions in that conference call, and his answers were very clear, without room for interpretation. Dean was asked specific questions regarding the NSE letter, and his response was a crystal clear "NO" and then it turns out these items actually were included as reasons for the rejection?? I'm no Lawyer, but I stayed at Holiday Inn Express once, and I think Dean may end up in some trouble before this story ends.
If in fact more info is released, showing a time line in which Dean was repeatedly asked for information from the FDA, that again he stated was not part of the reasoning for the rejection, I wouldn't want to be Dean when and if that summons arrives to appear in court.
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