(Total Views: 286)
Posted On: 04/10/2018 4:12:59 PM
Post# of 72446
Basher like Amatuer said Leo doesn’t plan to bring BTD onto the table. I replied by saying the FDA will bring it onto the table for you.
https://www.fda.gov/RegulatoryInformation/Law...341027.htm
Quote:
5) Does a sponsor have to request breakthrough therapy designation in order to be considered for the designation?
A sponsor needs to submit a request for breakthrough therapy designation in order to be considered for the designation. In some cases, FDA may suggest that the sponsor consider submitting a request for breakthrough therapy designation if: (1) after reviewing submitted data and information (including preliminary clinical evidence), FDA thinks the drug development program may meet the criteria for breakthrough therapy designation, and (2) the remaining drug development program can benefit from the designation.
https://www.fda.gov/RegulatoryInformation/Law...341027.htm
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