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The FDA told Invivyd that one Phase II/III randomized, double-blind, placebo-controlled trial evaluating mAb efficacy could support a BLA submission for VYD2311 in people ages 12 and older weighing at least 40kg (88 lbs), including immunocompromised people, subject to agreement on safety database size and a full protocol review.
[DOI] [PubMed] [Google Scholar] 498.Wangemann P
Neuron, 109 (3), 461472
On the other hand, it might also reflect a new steady state in which bone turnover is suppressed with long-term energy depletion, not unlike the skeletal changes in mice with CR
In trials (DURATION program), once-weekly exenatide 2 mg showed slightly more A1c reduction (~1.5% drop from baseline 8.3%) than Byetta BID (~1.0% drop) with fewer GI side effects after initial weeks ( [6] )
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