Biotech Values

[bxjwn9ru]

ARNA -

With respect to the clinical reasons, the FDA stated in the CRL that the weight loss efficacy of lorcaserin in 0verweight and obese individuals without type 2 diabetes is marginal and recommended that Arena submit the final study report of the BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial.

I'm puzzled by this statement. As we know the weight loss was marginal yet why aren't the FDA requesting new efficacy trials? Did they just reject it outright for the general population but have left it open for possible limited approval in obese diabetics as Dew mentioned? Appreciate any feedback.