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Furthermore, if we decide to submit an application for accelerated approval, there can be no assurance that such application will be accepted or that any approval will be granted on a timely basis, or at all

However, these combination therapies have not shown a significant increase in overall survival compared to chemotherapy alone [35,36,37,38]

This is particularly relevant for adults over 40, whose hormonal patterns, sleep architecture, and metabolic rhythms differ meaningfully from the younger populations in most clinical trial protocols

1 For those taking Wegovy HD, 89% achieved 5% or greater body weight loss versus 38% taking placebo (from a baseline body weight of 248 lb.)