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LIPAC Oncology Announces Two-Year Recurrence Free Survival Data for Phase 1/2a Study of LiPax in Patients With Non-Muscle Invasive Bladder Cancer

/PRNewswire/ LIPAC Oncology LLC., a pharmaceutical company utilizing its next generation precision liposomal technology to locally deliver taxanes to target. ....

Sherri Spear , Michael Oefelein , Leo Vartorella , Carolina Urologic Research Center , Drug Administration , Chief Medical Officer , Neal Shore , Lipac Oncology Llc , ஷெர்ரி ஈட்டி , கரோலினா சிறுநீரக ஆராய்ச்சி மையம் , தலைமை மருத்துவ அதிகாரி , நீல் கரை ,

LIPAC Oncology Announces Successful Type B Meeting with the U.S. FDA for the Study of LiPax for Non-Muscle Invasive Bladder Cancer

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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. ....

South Korea , United States , Sherri Spear , Michael Oefelein , Leo Vartorella , Drug Administration , American Urological Association , Chief Medical Officer , Will Robberts , Lipac Oncology Llc , தெற்கு கொரியா , ஒன்றுபட்டது மாநிலங்களில் , ஷெர்ரி ஈட்டி , அமெரிக்கன் சிறுநீரக சங்கம் , தலைமை மருத்துவ அதிகாரி ,

LIPAC Oncology Announces Successful Type B Meeting with the U.S. FDA for the Study of LiPax for Non-Muscle Invasive Bladder Cancer

LIPAC Oncology Announces Successful Type B Meeting with the U.S. FDA for the Study of LiPax for Non-Muscle Invasive Bladder Cancer
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South Korea , United States , Sherri Spear , Michael Oefelein , Leo Vartorella , Drug Administration , American Urological Association , Chief Medical Officer , Will Robberts , தெற்கு கொரியா , ஒன்றுபட்டது மாநிலங்களில் , ஷெர்ரி ஈட்டி , அமெரிக்கன் சிறுநீரக சங்கம் , தலைமை மருத்துவ அதிகாரி ,