Maybe not...if they get topline data in Q4, it will take some time to finish the analysis and get the NDA together. It would expect to see this in late Q1 or early Q2 '13. Even with a priority review, the FDA has six months from the time they file the NDA. They could approve sooner but are not obligated.
NDA gets filed in the spring. After NDA is accepted FDA may or may not convene ODAC depending on HOW GOOD the P III results are. ALL of these events will move the shares 1) NDA filing 2) ODAC announcement 3) ODAC meeting 4) ODAC vote 5) PDUFA date announcement
On outstanding data the FDA can go directly to PDUFA date announcement and skip the middle steps...that would blast off the shares. CEOs remarks assume a worst case where all the steps are needed and they all take the MAXIMUM time allowed. His remarks are therefore CONSERVATIVE and he is known for that. The facts is that any statement placing a DATE on any of the steps before the DATA becomes public by ANYONE is a WAG
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