Celsion Submits Response to FDA Warning Letter
Celsion Submits Response to FDA Warning Letter
June 1, 2004
Celsion Submits Response to FDA Warning LetterColumbia, MD - June 1, 2004: CELSION CORPORATION (AMEX: CLN) announced today that its response to the warning letter issued to it by the Food and Drug Administration (FDA) on May 7, 2004 was submitted to the FDA on Friday, May 28, 2004. As previously announced, the warning letter reflected certain matters that arose in connection with the Phase I and Phase II clinical trials of Celsion's Prolieve™ Thermodilatation system for the treatment of benign prostatic hyperplasia. The FDA granted Premarketing Approval (PMA) to Celsion for the Prolieve system earlier this year, and the system currently is being marketed under a distribution agreement between Celsion and Boston Scientific Corporation.
Tony Deasey, Celsion's Executive Vice President and Chief Operating Officer, said, "We took, and continue to take, the FDA's letter extremely seriously and have devoted significant attention and resources to our response. We believe that we have responded to the FDA's immediate concerns and have initiated actions necessary to address their longer-term comments on a schedule which, based on discussions with the Agency, we believe will be acceptable. We are putting processes in place to be fully compliant with FDA GCP regulations going forward. Our actions in response to the FDA's findings should help us to meet that goal and improve our clinical operations for the near and long term."
Carolyn Finkle, Celsion's Vice President, Regulatory Affairs, added, "We have responded promptly to the findings raised by the FDA in its May 7, 2004 letter and believe that we have addressed, or will address, all of the Agency's concerns. So long as we do so and continue to work with the Agency, we do not anticipate any further action by the FDA, including any actions that would affect the Prolieve PMA." Ms. Finkle also indicated that the Company intends to submit a redacted version of its response to the FDA shortly, with the request that Celsion's response be posted for public review on the Agency's website at www.fda.gov.
Tony Deasey, Celsion's Executive Vice President and Chief Operating Officer, said, "We took, and continue to take, the FDA's letter extremely seriously and have devoted significant attention and resources to our response. We believe that we have responded to the FDA's immediate concerns and have initiated actions necessary to address their longer-term comments on a schedule which, based on discussions with the Agency, we believe will be acceptable. We are putting processes in place to be fully compliant with FDA GCP regulations going forward. Our actions in response to the FDA's findings should help us to meet that goal and improve our clinical operations for the near and long term."
Carolyn Finkle, Celsion's Vice President, Regulatory Affairs, added, "We have responded promptly to the findings raised by the FDA in its May 7, 2004 letter and believe that we have addressed, or will address, all of the Agency's concerns. So long as we do so and continue to work with the Agency, we do not anticipate any further action by the FDA, including any actions that would affect the Prolieve PMA." Ms. Finkle also indicated that the Company intends to submit a redacted version of its response to the FDA shortly, with the request that Celsion's response be posted for public review on the Agency's website at www.fda.gov.
