great article Telesta and the FDA conducted a scheduled late-cycle teleconference with the objective of discussing any substantive review issues identified to date by the FDA. The review issues discussed were related to Chemistry, Manufacturing and Control issues (CMC) and Telesta’s manufacturing facility. As part of the meeting, the FDA briefly discussed the recent Advisory Committee and provided answers to several questions posed by the sponsor. A late-cycle meeting is not a decisional meeting and is used by the FDA to share information, identify deficiencies, and discuss any substantive review issues identified to date by the FDA and plan the rest of the review.
Dr. Michael Berendt, noted: “We are working closely with the FDA as they continue their review of MCNA and are providing additional information and as requested. We continue to believe that MCNA offers a positive risk-benefit ratio for the treatment of high-risk, non-muscle invasive bladder cancer patients who have failed front-line therapy, and remain optimistic that the FDA will come to the same conclusion as they complete their review.”
“Since the completion of the recent Advisory Committee, we have received an extremely high volume of correspondence from the bladder cancer community (patients, physicians, family members), investors and other interested parties seeking additional information about the probability of potential approval and availability of MCNA in the United States. Given the confidential nature of our discussions with the FDA and our development partners, we are not in a position at this time to provide any additional detail. We have updated the Frequently Asked Questions (FAQ) of our website to respond as best we can to the most common questions. As additional information can be made public, we will do so in an expeditious manner.”