-Entire Lymphoseek NDA Will Not be Re-reviewed-
-Review Process Could be Completed Expeditiously-
Report is Available for Download at: www.lifesciadvisors.com/clients/navidea
Navidea Biopharmaceuticals (NYSE Amex: NAVB) recently received a complete response letter (CRL) for the Company’s lead drug candidate for lymphatic mapping, Lymphoseek. We previously reported that there were no safety and efficacy concerns raised by the FDA and we believe that Lymphoseek’s superior clinical profile remains intact. In this note, we discuss several misconceptions that investors may have regarding the Lymphoseek CRL.
First and foremost, we want to reaffirm the fact that the Lymphoseek New Drug Application (NDA) is still under the FDA review process. Simply, the FDA issued a CRL to Navidea regarding issues with third-party contract manufacturer facilities that need to be resolved before the NDA application can be approved. Once Navidea and its contract manufacturers address these issues with the FDA, Lymphoseek will continue forward with its path for regulatory approval.
The Entire NDA Will Not be Re-reviewed. Some investors may think that because Navidea received a CRL for Lymphoseek, that the entire Lymphoseek NDA will be re-reviewed. This simply is not the case. Under CRL guidelines, when a company submits a response to a CRL issued by the FDA, the Agency only reviews items pertaining to the issues raised in the CRL. Moreover, the FDA CRL resubmission will respond only to specific deficiencies noted at third-party manufacturing facilities that will need to be addressed by Navidea prior to approval of the original application. Therefore, other items in the NDA that were not mentioned in the CRL will not be reviewed again.