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Biotech / Medical : 2012 Biotech Charity Contest
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To: tom pope who wrote (190)2/23/2012 3:59:59 PM
From: fred hayes   of 513
 
Tom, I am confident of approval based on listening carefully to the proceedings. FDA reps seemed to be focusing on the followup monitoring program. I think they are uncomfortable with the unmonitored use of the individual components, which seems to be gaining ground fast. My thesis has been that FDA wants control of the proceedings here, that they want the approved drug used withing the rules instead of seeing the generics gain ground. As you know by now, my biology knowledge is pretty lame -- but you develop certain muscles. I'm more confident about this one than I have been in a long time. That's not to say I couldn't be wrong, and my position is a small one...(:>)

fred
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