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pendragon8062

09/01/10 11:00 AM

#25230 RE: adrian taylor #25229

Which part of "completely new review team" at the beginning of the year do you not understand?

Bust has posted numerous times why the process essentially restarted with the new review team. Start counting from them and we haven't been it a year yet.

And if you look at the old team, there's a reason they and the CDRH head were all canned.
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mx10001

09/01/10 11:23 AM

#25233 RE: adrian taylor #25229

"Dean is walking in a mine field of his own doing."

Yeah, he did that by inventing a breakthrough technology that has the potential to make tons of money and save countless lives.

He has done that by tenaciously working with the FDA to recieve SE.

And you can sit back in your armchair at your computer and get butter from your popcorn all over the keyboard as you give voice to every doubt, fear, and malicious inuendo that you can muster, all the while avoiding the reality of any risk, let alone a minefield.