LIPAC Oncology Announces Successful Type B Meeting with the U.S. FDA for the Study of LiPax for Non-Muscle Invasive Bladder Cancer
Excerpt from the Press Release:
MENLO PARK, Calif., April 29, 2021 /PRNewswire/ — LIPAC Oncology LLC today announced the conclusion of a successful Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss Phase 2b/3 clinical trials of LiPax in patients with low-grade highly recurrent non-muscle invasive bladder cancer (NMIBC). The feedback from the FDA provides a clear path for LIPAC Oncology to initiate the Phase 2b trial for LiPax in the second half of 2021.
“We appreciate the thoughtful feedback and guidance from the FDA and acceptance of our proposed design for the Phase 2b/3 trial of LiPax,” said Michael Oefelein, M.D., Chief Medical Officer of LIPAC Oncology. “Non-muscle invasive bladder cancer is difficult to treat and highly recurrent. With the lack of existing treatment options for low to intermediate risk NMIBC, the unmet medical need is very high.”
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