Delcath (DCTH) to Continue with NDA Filing Following FDA Meeting
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On January 12, 2012, Delcath Systems, Inc. (Nasdaq: DCTH) met with the United States Food & Drug Administration (FDA) to conduct the scheduled pre-New Drug Application (NDA) meeting.
Based upon the meeting and FDA correspondence received in response to our meeting request and the briefing packet we submitted, we are satisfied with the responses that we received from the FDA to certain questions we had regarding the NDA submission.
Accordingly, we will continue with the preparation of our NDA submission as planned and expect to make the submission in the second quarter of 2012.
Based upon the meeting and FDA correspondence received in response to our meeting request and the briefing packet we submitted, we are satisfied with the responses that we received from the FDA to certain questions we had regarding the NDA submission.
Accordingly, we will continue with the preparation of our NDA submission as planned and expect to make the submission in the second quarter of 2012.
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