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The firm in its response described a cleanroom remodel , but the FDA found the supporting documentation insufficient: no specification documentation for ceiling tiles, no demonstration that materials are suitable for pharmaceutical use, no updated cleanroom certification, and no environmental monitoring data for the remodeled suite

Conclusions This post hoc analysis of SUSTAIN-6 did not find an association between the magnitude of weight loss achieved after 56 weeks of semaglutide treatment and subsequent MACE risk in people with T2D, suggesting that weight-independent mechanisms may mediate the cardioprotective effects of semaglutide

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2008;34 Suppl 2:S65-72