-No Safety/Efficacy Issues Reported with Lymphoseek-
- Issue Related to Third-Party Manufacturing-
Report is Available for Download at: www.lifesciadvisors.com/clients/navidea
Navidea Biopharmaceuticals (NYSE Amex: NAVB) recently received a CRL for the Company’s lead drug candidate for lymphatic mapping, Lymphoseek. We report that the concerns raised by the FDA in the CRL were related to cGMP issues. Most importantly, there were no safety and efficacy concerns raised by the FDA and we believe that Lymphoseek’s superior clinical profile remains intact.
CRL Resulted From cGMP Deficiencies Related to CMC, but Reconfirms Lymphoseek’s Safety and Efficacy Profile. As already noted, the CRL was issued based solely on cGMP deficiencies related to CMC that were observed by the FDA’s field office during the contract manufacturer site inspection process. Management noted on the call that no Lymphoseek safety or efficacy issues were raised by the FDA in the CRL and we believe that Lymphoseek’s superior efficacy and safety profile remains intact. We view this as a de-risking event as previous concerns that include disagreements over the appropriate clinical trial comparator have now been alleviated. We look forward to getting additional clarity on the CRL from management once they have had the appropriate discussions with the FDA.
No Additional Clinical Studies Required for Lymphoseek and a Short Resubmission Timeline for Lymphoseek is Expected. Importantly, we do not believe that Navidea will need to conduct additional clinical studies on Lymphoseek, which we believe will significantly speed up the process of responding to the CRL. We know that management is focusing much of their efforts now on addressing the CMC requirements raised in the CRL and will work to get a response to the FDA as soon as possible. While a timeline was not provided by management, we anticipate management’s response to the CRL and NDA resubmission within the next 6 months. We believe that even a response by the end of the year is certainly attainable. Ultimately, we do not anticipate the Lymphoseek commercial launch to be pushed backed 12 months or greater.