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Re: vibetech1 post# 32852

Monday, 11/29/2010 9:37:44 AM

Monday, November 29, 2010 9:37:44 AM

Post# of 59551
Vibe - You think that this will bleed like last time? I want to think that with McDermott on board, and their approval of resubmission, PPS would either hold or slowly move up. Everything sounds only positive right now. A conversation with the reviewer at RSNA, meeting with FDA, McDermott / I3 (who will know how to conduct a productive meeting with the FDA) and a cleaned up package, I would think that things are looking decent. Although the chances of overturning are not in our favor, I think we may have a solid case if everything is fixed, and the face to face at the FDA will confirm that all criteria are met in the new package. I'm feeling good about this.