Wednesday, February 13, 2013 11:03:37 AM
This view puts less value on a more objective, scientific analysis of the actual efficacy and safety data presented in the briefing docs, something which the FDA has been doing. Based on the data alone, the FDA should approve. This is a somewhat more complex argument (it's not a true binary event, the possibility of a restricted label must be considered) but it's still fairly basic and it may be correct.
It's a risky crapshoot. As I've stated before, if I wasn't already the holder of a large underwater position I probably would pass on this.
Best of luck to all.
All that is needed to make a happy life is within yourself, in your way of thinking. -Marcus Aurelius
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