_KS_ schreef op 20 mei 2020 09:41:
Uit Q1 2020 Earnings call transcript, 15 mei 2020; Tim geeft aan dat alle pts de 26W hebben doorlopen. Ook belangrijk, groot aantal pts die door zijn gegaan in extension study :
On slide 5, ADAPT our Phase 3 trial of efgartigimod in gMG. That study remains on track. I must pay tribute here to the hard work from our MG team. We enrolled this trial faster than anticipated which turned out to be an incredibly important milestone particularly in view of the current situation.
By the time the shelter-in-place restrictions went into effect, all 167 patients in ADAPT had already passed the eight-week time point for the analysis of the primary end point and the majority of patients had already rolled over into the open-label extension. As an update today, all patients have now completed the 26-week primary trial.
We will be reporting top line data mid this year, which sets us up to file a BLA before the end of 2020, assuming success and to launch in 2021 in the United States. Additionally, we are on track to file in Japan in 2021.
We were very pleased with the high degree of rollover to the open-label extension study
, which remains firmly on track.Link: seekingalpha.com/article/4347992-arge...