GREY:IPHAF - Post by User
Comment by
labumbaon Mar 02, 2010 8:30pm
467 Views
Post# 16836084
RE: Baby Steps
RE: Baby StepsWe are in the mode of high speed recovery.....Acceptance from FDA IN APRIL ...approval of NDA " WITHIN " SIX MONTHS !...." WITHIN " means " could be shorter than six months "......we will see the green light in third quarter the latest !........NDA for psoriasis is comming up in May or June.......who knows we may get a partner for " transplant " indication development .....lots of action !
My understanding is ISA increased the numbers of participants in Canada / Europe psoriasis trial and prolonged the lenght of the trial in order to waive the psoriasis trial requirement in US, Correct me if I'm wrong..