Twinkie schreef op 10 maart 2017 08:59:
FDA discussions ongoing over next steps in prophylactic setting. Recall
Pharming reported compelling Phase II data from a 32-patient study using
Ruconest for the prophylactic treatment of HAE. The outcomes (96% response
rate with twice-weekly dosing) and trial design (similar to Cinryze’s pivotal
study in 22 patients) suggest to us that Pharming has a strong case for
seeking conditional approval on the Phase II data, although our current
assumption is that a Phase III trial will be required. Discussions with the FDA
are ongoing and we expect a resolution by mid-2017.
www.fda.gov/AnimalVeterinary/Resource...Adem in, adem uit.