NEW YORK, Feb. 22, 2011 /PRNewswire/ — Delcath Systems, Inc.
(Nasdaq:
DCTH) announced today that the Company has received a “refusal
to file” letter from the U.S. Food & Drug Administration (FDA)
for the New Drug Application (NDA) for its proprietary
chemosaturation system used in the treatment of patients with
metastatic melanoma in the liver through the percutaneous
intra-arterial administration of melphalan hydrochloride.
Delcath expects to submit a formal meeting request to the FDA
this week and intends to meet with the FDA at the earliest
opportunity to discuss the issues raised and to confirm our
understanding of the remedies required for the filing to be
accepted. Based on management’s current understanding of the
information in the FDA’s letter, the Company intends to resubmit
the NDA by September 30, 2011.
In accordance with application regulations, the FDA has the
ability to formally file or refuse to file an application within 60
days of the completion of the submission, which occurred on
December 22, 2010. Neither the acceptance nor non-acceptance
of the NDA filing is a determination of the approvability of the
chemosaturation system.
“The FDA’s letter requested information involving manufacturing
plant inspection timing, product and sterilization validations and
additional safety information that we already planned on filing
with our 120 day safety update in April, as well as additional
statistical analysis clarification,” said Eamonn P. Hobbs, CEO
& President of Delcath Systems. “We believe that we will be
able to provide the requested information in an updated application
and we expect to resubmit the NDA by the end of the third quarter
of this year. In the meantime, the CE Mark Technical File
review process for marketing approval of the Hepatic
ChemoSAT™ Delivery System continues on schedule. Our
expec
‘/>”/>
SOURCE
