Encouragingly, the planned Phase IIb study, to be called AIPAC (Active Immunotherapy PAClitaxel) is considered well designed by the Agency. AIPAC is now expected to initiate in Europe during the 4th quarter of 2015. While the EMA never endorses any statement on the likelihood of future regulatory decisions, the Agency’s communication has suggested that the achievement of certain clinical endpoints may lead to Marketing Authorization in the EU based on this one pivotal study.
There it is in black and white Joe.......March results will determine EMA's reaction.....What those certain clinical endpoints
are is anyone's guess, but Immutep have recently
Expanded production capacity with partner Wuxi, Wuxi was first Chinese manufacturer approved to supply Europe, with EFTI.
European Aipac trial bridged to USA to potentially allow marketing in Europe with a licenced partner for that region
whilst continuing AIPAC in the US under Immutep's and Frederic's control.....
So Joe, depending if AIPAC results are favourable and in turn how favourable it seems Immutep are primed for
action if it receives the go ahead.....Just my thoughts, make up your own minds....
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Encouragingly, the planned Phase IIb study, to be called AIPAC...
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