EMA - Conditional marketing authorisation"The European Medicines...

EMA - Conditional marketing authorisation

"The European Medicines Agency (EMA) supports the development of medicines that address unmet medical needs. In the interest of public health, applicants may be granted a conditional marketing authorisation for such medicines on less comprehensive clinical data than normally required, where the benefit of immediate availability of the medicine outweighs the risk inherent in the fact that additional data are still required.Medicines for human use are eligible if they are intended for treating, preventing or diagnosing seriously debilitating or life-threatening diseases. This includes orphan medicines."

AIPAC 2b - OS data, if good may qualify for above. We know Efti is safe and increased manufacturing capacity is WIP.

'Conditional marketing authorisation is good for 1 year only and can be renewed'...
The available data must indicate that the medicine’s benefits outweigh its risks and the applicant should be in a position to provide the comprehensive clinical data in the future = AIPAC P3 with partner - imo.