Objective
The goal of the review is to identify any gaps that need to be addressed prior to applying to the FDA for approval to start a clinical trial, in order to maximize the likelihood of clinical trial application approval.
Background Rationale
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Description of Project
Supported by Breakthrough T1D, Dark Horse Consulting will, through their consultative services, review the work preformed to date by a Breakthrough T1D grantee working on developing a material to allow beta cell implantation without long term immunosuppression. The goal of the review is to identify any gaps that need to be addressed prior to applying to the FDA for approval to start a clinical trial, in order to maximize the likelihood of clinical trial application approval.
Anticipated Outcome
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Relevance to T1D
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