![]() Portola isn't the only one that is disappointed, investors and analysts showed their distaste for the development. So leading up to the PDUFA date this was a little bit of a surprise." "We were confident in the science, confident in the clinical data that we provided, and confident that we met the requirements of accelerated approval. "We do expect to be communicating with the FDA in the very near-term," said Portola CEO Bill Lis on the call. The letter also indicated that there needs to be further review and discussion of recently submitted clinical amendments to Portola’s post-marketing commitments. ![]() In the CRL for AndexXa, the agency requested that Portola provide additional information on manufacturing, as well as additional data to support inclusion of edoxaban and enoxaparin in the label.
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