Comment from Rejuvenation Technologies
AnonymousSupportBusiness
Summary: Rejuvenation Technologies, a biotechnology company, supports the draft guidance but requests specific clarifications to ensure the Plausible Mechanism Framework includes therapies for multi-gene convergent conditions like telomere biology disorders. They argue that the current language focusing on single genetic variants might inadvertently exclude treatments that address a common downstream mechanism across multiple genes.
See attachment relating to recommendations for Plausible Mechanism Framework Draft Guidance for Industry.