In a major setback for Dor BioPharma, the FDA has issued a not approvable letter for the company's lead drug orBec, a treatment for gastrointestinal Graft-versus-Host disease (GI GVHD). The FDA said that it wants data from additional clinical trials of the drug in order to prove its safety and efficacy. The agency also requested information about other sections of the NDA.
"We are very disappointed that the FDA has deemed orBec not approvable and that additional clinical trials will be required," said Christopher J. Schaber, PhD, President and Chief Executive Officer of DOR. "We will be requesting a meeting with the FDA to discuss this letter and the potential next steps that need to be taken. We will also be reviewing the various business development opportunities we potentially have before us. Once we gain further clarity, we will be able to provide accurate guidance moving forward."
- check out Dor's release for more