pe26 schreef op 2 juli 2019 07:16:
@AnalytischDenker: hieronder meer duiding van Morgan Stanley, zodat je het beter begrijpt:
"Timing for a U.S. launch has been a key investor focus given filgotinib is likely to launch in RA after competing JAK upadacitinib (for which an NDA has been filed), and investors were uncertain how much MANTA safety data the FDA would require to accept a regulatory filing for filgotinib. As we had highlighted in our recent month ahead note (see here), we believe a 2019 filing plan is a bull case scenario and clearly indicates that the FDA is comfortable with interim safety data from the MANTA studies being included in a filing
. A requirement for complete MANTA study data would have significantly delayed filing, as primary completion dates for the MANTA studies are in 2021.
@AnalytischDenker: met Fast Track doel je op Priority Voucher..?
De Priority Voucher zet je pas in als je daadwerkelijke NDA-aanvraag doet.
In H2 2019 kan Gilead dit doen, indien zij een verkregen/extern gekochte PRV inzetten.