beeldscherm schreef op 29 juni 2018 11:09:
EMA demands more data from Amicus, denting stock
The EMA has told Amicus Therapeutics it lacks the data to file for conditional approval of its Pompe disease drug in Europe. Amicus needs to gather data on more patients and track the progress of previously treated people before seeking conditional approval, delaying the filing to 2019 or beyond.
New Jersey-based Amicus had hoped the unmet needs of patients with the rare metabolic disease would persuade the EMA to allow it to file for approval on the strength of phase 1/2 data. But, having taken a look at the data, the EMA’s scientific advice group has concluded Amicus must build out the clinical package for recombinant human acid alpha-glucosidase AT-GAA before filing
www.fiercebiotech.com/ema-demands-mor...kijk maar het omgekeerde kan wel voor Pharming gebeuren.....