Positive CMC Meeting with FDA for IMNN-001 in Treatment of Advanced Ovarian Cancer Announced
“We are very pleased with our recent FDA interactions as we continue to work collaboratively with the Agency to align on the most expeditious path to advance IMNN-001 into Phase 3 and toward potential commercialization for the thousands of women with newly diagnosed advanced ovarian cancer in need of additional treatment options,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The FDA’s agreement with our plan to meet key CMC requirements is highly encouraging, establishing our ability to produce our gene-mediated therapeutic for our Phase 3 pivotal trial as well as creating a highly cost-efficient framework for potential commercialization.”
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