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Posted On: 05/01/2025 12:13:24 PM
Post# of 154678
You can resubmit for BTD. Just thought I’d share this since I was having a good discussion about this with someone via DM.
“When a BTD request is denied, the sponsor has the option to submit a new request to provide additional data. Among the 93 BTD requests that were granted, 8 (9%) were new submissions that were previously denied by FDA but were resubmitted with a revised indication or with additional data, to support the request“
https://pmc.ncbi.nlm.nih.gov/articles/PMC1076...hatgpt.com
“When a BTD request is denied, the sponsor has the option to submit a new request to provide additional data. Among the 93 BTD requests that were granted, 8 (9%) were new submissions that were previously denied by FDA but were resubmitted with a revised indication or with additional data, to support the request“
https://pmc.ncbi.nlm.nih.gov/articles/PMC1076...hatgpt.com
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