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The FDA published a new draft guidance on 24 June 2022 entitled "Considerations for Rescinding Breakthrough Therapy Designation (BTD)" - have you seen it? If not, take a look at the attachment - it's a quick read. The AAPS Reg Science Community board would love to have a discussion here on this new draft guidance. What are your thoughts on this draft guidance? Have you had a BTD rescinded on a project? If so, what were the circumstances (new clinical - safety or efficacy - data? another product approved for the same indication? something else?)? At what stage of development was the BTD originally granted? When was it rescinded? Do you feel that this change in designation was warranted? Please feel free to comment anonymously so that we can have a robust discussion. Thank you!