BlackHawk schreef op 4 januari 2018 12:17:
Ik weet ook niet waarom dit zo hardnekkig is? Dit staat op papier:
Pharming will file for accelerated FDA
approval in 4Q17. This provides potential upside to our prior expectations for approval/
launch for prophylaxis use by end-2019, which had assumed a pivotal study requirement
for approval. While a confirmatory trial is still likely, the prospect of being able to prescribe
Ruconest for acute and prophylaxis use in HAE, 12-18 months ahead of schedule,
is a clear positive. "
we believed Pharming had a good case to be made for conditional approval.
Assuming an sBLA filing in 4Q17 we estimate potential FDA approval by 2H18, with
launch timing dependent on a priority (6 months) or standard (10 months) review timeline.