The FDA has concluded that the comparability data submitted for the material manufactured using the proposed commercial manufacturing process was not adequate to demonstrate that it was representative of the material used to establish the safety and efficacy of KRYSTEXXA in its Phase 3 clinical trials.
The FDA stated that the Company has the option detailsview item updating your resume either reverting detailsview item updating your resume and validating the manufacturing process used to produce KRYSTEXXA for the Phase 3 clinical trials or conducting additional comparability clinical trials to support the use of KRYSTEXXA manufactured using the proposed commercial manufacturing process.
The Company currently expects that it will seek to address this issue by reverting to and revalidating the manufacturing process used to produce KRYSTEXXA for the Phase 3 clinical trials. S unique matchmaking for other income streams.
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