Since the 30mg dose apparently has good efficacy, the fact that Servier decided to go with solely the 60mg dose in phase-3 suggests that safety is not as big a concern in this indication as you might think.
Would that I trusted any company to be properly aligned with the FDA when it comes to relatively rare SAE issues in non-fatal diseases. Even very savvy big pharma seems to routinely dismiss SAE signals just because they aren't stat sig in any one trial - even if it pops up as 2x RR in multiple trials. E.g. one of the IL-1 inhibitors taken to the FDA for gout.
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