BUFFALO, N.Y. — A Buffalo biotech company is moving ahead with plans for a brain cancer immunotherapy vaccine after receiving fast track approvals from the FDA.
MimiVax LLC, which spun off from Roswell Park Comprehensive Cancer Center, has been developing its SurVaxM therapy for several years for treatment of glioblastoma. The fast-track designation from FDA expedites the review process for drugs that meet the need to address a serious conditions, said co-founder/CEO Michael Ciesielski.
“It speeds everything up incredibly,” he said.
Fast track approval, he said, gives MimiVax enhanced access to meetings and consultations with FDA officials; a rolling review process throughout the development of the drug; and accelerated approval and priority views when the company is ready to submit a new drug application.
Read more of this article from our partner Buffalo Business First.
