It would be a BLA. I don't know what the advantage would be for NFLD beyond four months shorter review time. Shorter is always better because it allows you to get on the market faster.
The rolling submission aspect of Fast Track has always seemed to me to be a red herring for investors. The PDUFA date isn't set until you file the last piece, which is no different than if you file it all at once. There are sometimes internal operational and perhaps even review benefits (if you file clinical and safety first like DNDN did) to rolling submissions, but it makes no difference for investors.
I think NFLD holders have the common misconception that Fast Track is some sort of a signal that things will go well at the FDA. We've discussed that it isn't.
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