ohm20 Monday, 01/13/20 05:59:00 AM This may e
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Posted On: 01/13/2020 6:07:30 AM
ohm20 Monday, 01/13/20 05:59:00 AM
This may explain filing with little data.
Quote:
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.
http://www.fda.gov/regulatory-information/foo...-therapies
This may explain filing with little data.
Quote:
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.
http://www.fda.gov/regulatory-information/foo...-therapies
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