bluebird bio Confirms FDA Has Communicated That Advisory Committee Meeting Will Not Be Scheduled For Lovo-Cel Gene Therapy for Sickle Cell Disease
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The FDA has confirmed that it will not schedule an Advisory Committee meeting for bluebird bio's Lovo-Cel gene therapy for Sickle Cell Disease. The agency had previously accepted the Lovo-Cel Biologics Licensing Application (BLA) for Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023.
August 16, 2023 | 11:02 am
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The FDA's decision not to schedule an Advisory Committee meeting for bluebird bio's Lovo-Cel gene therapy could potentially expedite the review process. The PDUFA goal date remains December 20, 2023.
The FDA's decision to not schedule an Advisory Committee meeting could be seen as a positive sign, as it may indicate that the agency does not see any major issues that would require a committee review. This could potentially expedite the review process, which would be beneficial for bluebird bio. However, the final decision will still be based on the PDUFA goal date of December 20, 2023.
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