COLUMBIA, Md.--(BUSINESS WIRE)--CELSION CORPORATION (AMEX:CLN) today reported that It had met with the FDA on July 23 and July 25, 2007 to discuss its upcoming pivotal primary liver cancer study.
At the first meeting the company discussed issues raised by the FDA in relation to the protocol submitted to the FDA for review under its Special Protocol Assessment (“SPA”) process. At the meeting the Company reached broad agreement with the agency on outstanding study design issues. Celsion plans to submit the revised protocol and supporting documents soon. Assuming continued agreement with the FDA Celsion hopes to have FDA approval for the protocol in late September.
