Immutep will advance its discussions with the regulatory authorities accordingly.“mmutep CEO, Marc Voigt stated: “We are pleased to see a clinical benefit for patients receiving efti in HR-positive metastatic breast carcinoma in multiple patient subgroups”
”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 suggests sted that the achievement of certain clinical endpoints may lead to Marketing Authorization in the EU based on this one pivotal study”.
With the APAIC ph2b trial ,being completed in May, data results can’t be too far off.
DYOR
Media, page-18
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