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Amazon's approach makes a deliberate departure from that model
What the study does provide is a clinical signal that aligns with the mechanistic story
This strategy has been exploited in the long-acting GLP-1RA semaglutide (Novo Nordisk), for instance, which was approved for treatment of T2DM in 2017, and for treatment of obesity in 2021, and has since then become the most prescribed GLP-1RA 92
A second CRL can add years, particularly when it involves manufacturing deficiencies requiring facility remediation
