Replies to post #35299 on Biotech Values

[jellybean]

What would be the advantage of fast-track status at this point in development? Rolling submission of the BLA? Is it a BLA or NDA?

[DewDiligence]

> NFLD – If the data are beyond any hint of rapproach, they'll get Fast Track. If not, they'll get full review. I think it has next to nothing to do with superiority/non-inferiority.<

I think you may be analyzing too deeply. The bold-faced text in #msg-13926630 makes it fairly clear that the decision does depend, at least in part, on whether NFLD achieves superiority or merely non-inferiority.