kmmr schreef op 12 juni 2019 21:41:
Ik heb zojuist de prospectus doorgelezen van de emissie.
op pagina 90 staat het volgende:
"The second Day 180 List of Issues is a common step in the EMA review process. Addressing the second Day 180 List of Issues did not require new experimental or new clinical data to be generated, and was focused on one remaining major observation. We have thoroughly analyzed this observation and as part of our answers have created multiple analyses of existing clinical data to address this observation, including analyses of various (pooled) ATIR and historical control data. We aim to receive a CHMP opinion in 2019 –
in June 2019 at the earliest - which, if positive, would enable us to receive a conditional marketing approval from the European Commission, followed by commercial use of ATIR101 in a first patient in a European country at the end of 2019"
www.kiadis.com/wp-content/uploads/201...Nogmaals een bevestiging dat het hier ging om het analyseren van bestaande data, en vanuit Kiadis ook een bevestiging dat de goedkeuring in juni al kan komen.
Dit worden een paar mooi weken!