Delcath Systems has received a 'refusal to file' letter from the US Food and Drug Administration (FDA) for the new drug application (NDA) for its proprietary chemosaturation system.
The chemosaturation system is used in the treatment of patients with metastatic melanoma in the liver through the percutaneous intra-arterial administration of melphalan hydrochloride.
Based on the information in the FDA’s letter, Delcath intends to resubmit the NDA by 30 September 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 22 December 2010.
Delcath Systems CEO and president Eamonn Hobbs said 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.
As Delcath plans for the anticipated European commercial launch of the Hepatic ChemoSAT Delivery System in the second half of 2011, the company expects the monthly burn rate will rise in the coming quarters.