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Hi all,
Would it be possible to file a type II variation application for a new indication, while another type II variation for another new indication is already undergoing assessment at the EMA?
The 2 new indications would not be linked to the same condition/patient population (neither would they be linked to the initial indication approved). My initial understanding was that we would be forced to either submit the 2 new indications at the same time (not ideal as clinical development will likely not complete exactly at the same time), or that we would have to wait for CHMP Opinion on the first type II variation before being allowed to file a new indication type II variation.
Are you aware if there is a precedent or a potential strategy to allow a filing in a staggered manner ?