Comment from Wave Life Sciences
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Summary: Wave Life Sciences, a biotechnology company, welcomes the draft guidance as a positive step toward streamlining the development of individualized therapies for rare diseases. They advocate for clarifying the framework's applicability to broader populations and suggest incorporating specific examples regarding AI and nonclinical program abbreviations.
On behalf of Wave Life Sciences (‘Wave’), please find enclosed comments on the published draft guidance for industry entitled: ‘Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause’.