beeldscherm schreef op 15 november 2017 12:09:
Pharming announces conclusion of FDA End of Phase 2 interactions on RUCONEST® for Prophylaxis of HAE
Leiden, The Netherlands, 11 Sep 2017: Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM) announced today that it has concluded its End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA). As part of these interactions, Pharming provided the FDA with the results of two completed Phase 2 trials of RUCONEST® for the prophylaxis of HAE attacks; a randomized, double-blind, placebo-controlled trial and an open-label study. The two studies enrolled a total of 56 patients and showed consistent efficacy and safety results.
Based on the feedback from the FDA, Pharming will submit a BLA supplement (sBLA) to the FDA for review in Q4 of this year, which will include routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE) as an expanded indication for RUCONEST®.
lees eens aandachtig.. wat ik hieruit opmaak/vertaal is, dat Pharming al VOOR 11 sept. contact heeft(gehad) met de FDA dus al de uitkomst vd trials v Sept 11 bij fda (kan misschien al 1Sept zijn geweest / of nog eerder, en dan "for review Q4, blijf ik erbij dat ze dit al begin (1 ?) Okt. hebben gedaan, tel daar de 74 dgn(max) bij op....