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To view or add a comment, sign in I appreciated the opportunity to be interviewed by Nick Paul Taylor for this BioSpace article discussing the FDAs recently published draft guidance, General Considerations for the Use of New Approach Methodologies in Drug Development. Historically, drug developers have often included in vitro NAM assay reports in regulatory submissions with limited explanatory context, resulting in minimal impact on the regulators safety assessment

This produced modest weight loss with minimal side effects

& Seeley, R

The drugs molecular structure has been public for years, since Eli Lilly published it in a research paper in 2022

17 Similar findings have been reported in analyses of subjects who underwent metabolic surgery compared with those who did not