geht nach einer kurzen Explosion auf Start zurück und ins Minus!
Die Studie Bekinda in der Indikation startete im September 2014 und hat somit ca. 2,5 Jahre gedauert. Eine Zusatzstudie dürfte einige Zeit in Anspruch nehmen, falls vor der Zulassung verlangt.
https://clinicaltrials.gov/ct2/show/...246439?term=redhill&rank=8
Terry F. Plasse, MD, RedHill's Medical Director, added: "We are excited about the positive outcome of the Phase III GUARD study, which met its efficacy primary endpoint and demonstrated the safety and tolerability of BEKINDA® 24 mg. Notably, when looking at results by initial severity of nausea, we see a treatment effect even in patients with very severe nausea at baseline, suggesting that the drug works regardless of the initial severity of gastroenteritis. We continue to analyze the data, with the final clinical study report expected in the third quarter of 2017. We look forward to presenting the data to the FDA and discussing the potential path for marketing approval of BEKINDA® 24 mg in the U.S. and whether additional clinical studies are required prior to NDA filing. We are also expecting top-line Phase II results from the clinical study of BEKINDA® 12 mg in diarrhea-predominant irritable bowel syndrome (IBS-D) in September 2017. I would like to thank the patients, investigators, clinical staff and service providers who participated in the GUARD study and commend the RedHill team for achieving this important milestone."
Da könnte das Problem liegen, wie beim Nachbarforum vermutet wird - die Ergebnisse sind nicht gut genug, um gleich einen Zulassungsantrag in USA zu stellen. Und in obigem Text: "and whether additional clinical studies are required prior to NDA filing." |
