Replies to post #41206 on Biotech Values

[AlpineBV_Miller]

[Fast track] it may enable an earlier NDA/BLA submission than would otherwise be the case.

Is this even true? The PDFUA date isn't set any earlier than it otherwise would be. I don't see any speed benefit in filing a rolling app.

I've asked company reg heads this question before and received mixed answers. The "yes it is faster" answers never made much sense to me, though.