>So, I am a bit confused about the actual advantage for fast track late in development and the FDA's decisions regarding the granting of such.<
Fast Track means almost nothing at that stage of development but there is no downside, so you might as well ask for it.
DNA did not get Fast Track for Lucentis because Macugen was already approved in the same indication using a similar MoA. The posters on the GENR ymb made a very big deal out of Lucentis’ lack of Fast Track, asserting that it meant Lucentis wouldn’t be approved. I tried to warn them, but you know how it is…
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