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Posted On: 02/20/2022 10:39:12 AM
Post# of 154141
An answer to a post that has been deleted.
How about 27?
The number of patients isn't listed there but the link to the conference lists 27 patients.
Then the rejoinder will be "but the leronlimab data comes from multiple sources". The FDA will accept BTD data from multiple sources.
https://www.accessdata.fda.gov/drugsatfda_doc...Corres.pdf
Quote:
Can you provide an example of a cancer BTD that was approved with an N of 28?
How about 27?
Quote:
Iovance Biotherapeutics Announces Breakthrough Therapy Designation for LN-145 for Treatment of Advanced Cervical Cancer Patients Who Have Progressed on or After Chemotherapy
The company will present the data on June 1, 2019, at the American Society of Clinical Oncology (ASCO) Annual Meeting.
PR link
The number of patients isn't listed there but the link to the conference lists 27 patients.
Quote:
Results: As of 4 Feb 2019, 27 efficacy-c patients have received Gen 2 of LN-145
https://ascopubs.org/doi/abs/10.1200/JCO.2019...suppl.2538
Then the rejoinder will be "but the leronlimab data comes from multiple sources". The FDA will accept BTD data from multiple sources.
https://www.accessdata.fda.gov/drugsatfda_doc...Corres.pdf
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