I suspect their IRB will stop the second arm of the Phase 3 trial. This arm had a drug holiday to attempt to moderate side effects, but the arm showed no statistical benefit at week 48. It will be difficult to justify the risk of SAEs in this arm with little to no clinical effect. For that matter, they should consider the risk benefit of the SAEs vs the moderate value seen in the drug arm. At 48 weeks, this arm had ~35 meters difference vs placebo. The etep benefit at 48 weeks was ~59 meters with NO SAEs... The choice is clear!
Important to note: The US Phase 3 trial was set to begin enrollment in early March. It seems to be on hold and not enrolling. Maybe the Drug Safety Review Board was waiting on the Phase 2 data to inform their decision. Remember, the most expensive development program is the one that fails after Phase 3.