beeldscherm schreef op 10 november 2017 10:24:
nogeens ff update v HC Wainwright&Co ( September 26, 2017) aant na-pleuzen maar staan toch leuke dingen in,zoals deze,
..Recent FDA interaction, or lack thereof, presents best scenario possible, in our belief. On September 11, Pharming
announced that it would file a supplementary BLA (sBLA) in 4Q17 to potentially expand the Ruconest label into the prophylaxis
setting. This was based in large part on feedback from the FDA and the publication of the Phase 2 prophylaxis data. Further,
the end-of-Phase 2 meeting, which had been previously scheduled, was cancelled by the FDA and not required. We interpret
this as a further positive signal for the path forward in the prophylactic setting.
maw staat hier al infeite dat ze het gebruik van Ruconest label voor prophylaxis - GOEDKEUREN - want er staat dat ze de tweede ontmoeting met Pharm gecanceld hebben en er GEEN tweede gesprek komt/volgt maw ze vinden de data en commentaar vd Patienten OVERTUIGEND genoeg !!