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Posted On: 05/08/2025 1:31:19 AM
Post# of 153064
Jan 13, 2020 -- CytoDyn Files for Breakthrough Therapy Designation for Leronlimab in Metastatic TNBC
https://www.cancernetwork.com/view/cytodyn-fi...tatic-tnbc
& add this:
No, an FDA Breakthrough Therapy Designation application itself does not expire. Once granted, the designation remains in place, but the FDA can rescind it if certain conditions are met. The FDA will respond to a Breakthrough Therapy designation request within 60 days of its receipt.
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With a few adjustments after having verified the abstract data, Dr. J is sitting on more potential mTNBC surprises
That "Abbreviated timeline".....
https://www.cancernetwork.com/view/cytodyn-fi...tatic-tnbc
& add this:
No, an FDA Breakthrough Therapy Designation application itself does not expire. Once granted, the designation remains in place, but the FDA can rescind it if certain conditions are met. The FDA will respond to a Breakthrough Therapy designation request within 60 days of its receipt.
_____
With a few adjustments after having verified the abstract data, Dr. J is sitting on more potential mTNBC surprises
That "Abbreviated timeline".....
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