Lama Daila schreef op 20 maart 2019 20:20:
twitter.com/lama_daila/status/1108447...De tweet van Biotechradar komt uit de webinar van Kiadis op de Oppenheimer Conference gisteren (19 maart).
www.veracast.com/webcasts/opco/health...Ik heb een transcript gemaakt van dit stukje rond minuut 21:
What are the milestones we are guiding on?
One is in 2019 the CHMP opinion.
We originally expected to have it before the summer, but we just announced - two weeks ago or last week, yes, last week, we asked for a 1-month extension from the EMA to submit the answers to the final questions, because we are waiting for the final analysis from a service provider, that we need to put in that answer.
However, it doesn’t have an impact on the guidance we have given for the commercial launch, because it never was on the critical path for this guidance. We still fully expect to make our first sale in 2019.