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 [Suppressed Image]