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Project Timeline
Spring Point Project's medical grade pigs are available for use in clinical trials, however the FDA has requested that the University of Minnesota conducts a series of safety and efficacy studies using the islets from these pigs in preclinical models before proceeding to a Phase I/II clinical trial.
These studies are currently underway at the Schulze Diabetes Institute at the University of Minnesota. The data is scheduled to be submitted to the FDA for review in mid-2011. The length of the review period is unknown but it is hoped that the data will be sufficient to warrant a speedy approval.
