The FDA handed back Delcath Systems' ($DCTH) NDA for its targeted chemosaturation system along with a refuse-to-file letter outlining the agency's demands for additional information. And investors fled on the news, driving down Delcath shares by 32 percent in pre-market trading.
In a release, the biotech said it would be able to respond to the FDA with a revised NDA by the end of September. The developer filed the app just before Christmas, asking for regulatory approval of a new approach to blasting specific cancer targets with high concentrations of chemotherapy. Last year investigators reported promising results in a late-stage liver cancer trial.
"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 Hobbs, CEO 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 expectation remains that we will be able to begin addressing the significant European market opportunity by mid-year."
Last April, Delcath was all confidence as it reported a promising end for a late-stage study, with an average rate of progression-free-survival at about seven months for liver cancer victims. Hobbs was estimating sales of $745 million a year and analysts were upbeat about a potential approval, given the FDA's special protocol assessment on the late-stage trial design.
- here's the Delcath release