Catalyst

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Additional Information

Additional Relevant Details The CRL refers to observations arising from a pre-approval manufacturing inspection. The FDA also acknowledged receipt of recently-submitted data which it has yet to review. The CRL does not require the generation of new clinical data. AstraZeneca and ZS Pharma are evaluating the content of the CRL and will work closely with the FDA to determine the appropriate next steps for the NDA.
https://www.astrazen...
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Catalyst Date
Occurred on:
May 27, 2016
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