FDA Has Posted Briefing Documents For Exa-Cel Adcomm; FDA Staff Reviewers Say It Is Not Clear If Limited Donor Cells Used In Off-Target Assessment Is Adequate To Inform Potential Safety Risks Of Vertex's Sickle Cell Therapy
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The FDA has posted briefing documents for Exa-Cel Adcomm, expressing concerns about the adequacy of limited donor cells used in off-target assessment to inform potential safety risks of Vertex's sickle cell therapy.
October 27, 2023 | 1:15 pm
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NEGATIVE IMPACT
CRSP, although not directly mentioned, may be indirectly affected by FDA's concerns about the safety assessment of cell therapies.
CRSP, a company involved in gene editing and therapies, may be indirectly affected by the FDA's concerns about the safety assessment of cell therapies. This could lead to increased scrutiny on CRSP's products and potentially impact its stock negatively.
CONFIDENCE 70
IMPORTANCE 60
RELEVANCE 50
NEGATIVE IMPACT
FDA's concerns about the safety assessment of Vertex's sickle cell therapy could potentially delay its approval.
The FDA's concerns about the adequacy of the safety assessment of Vertex's sickle cell therapy could potentially lead to further investigations or requirements, which may delay the approval of the therapy. This could negatively impact Vertex's stock in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100