The Pathway Development Consortium (PDC), a new public-private collaboration founded by REGENXBIO Inc. (Nasdaq: RGNX) and Solid Biosciences Inc. (Nasdaq: SLDB), today announced the publication of a draft white paper, Draft Framework for AAV Gene Therapy Development, which proposes a framework that can be applied to AAV gene therapies to facilitate the use of the accelerated approval pathway at the US Food and Drug Administration (FDA). The white paper identifies different categories of AAV gene therapies that target the underlying monogenetic changes that cause disease and proposes generalized approaches that would clarify the evidence needed to support FDA approval. The PDC is actively seeking feedback from key stakeholders on this framework at info@pathwaydevelopmentconsortium.org.
For further information, see Solid Bio (https://investors.solidbio.com/news-releases/news-release-details/pathway-development-consortium-releases-draft-white-paper)
