Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Jeg tror TRVX søkte og fikk godkjenning basert på mesothelioma data annonsert 24 november 2020 (18 month analysis).
1 desember annonserte de enda mer overbevisende data i refractory melanoma.
Jeg vil tro de har sendt inn request for FTD i refractory Melanoma basert på disse dataene og at vi får servert en ny FTD i melanoma veldig snart.