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If the primary trial isnt published yet, its challenging to understand what the benefit is versus existing treatments. Pathway provider It seems like the FDA is giving breakthrough designations to everything these days - MCO When manufacturers are pursuing expedited FDA-approval, it would be beneficial to educate payers and providers on the reasoning and evidence behind a products accelerated approval to ease common misconceptions and concerns

Vegliante R, Di Leo L, Ciccarone F, Ciriolo M

The reason for this can be anything from patient therapeutic response to objectives, but most of the time, it can get injected 2-3 times a week

Discontinuation due to adverse events was numerically higher in the combination arm at maximum doses, though the trial was not powered to establish statistical significance on that endpoint