Biotech Values

[biomaven0]

>>Semprana/Levadex

Moral here is that any drug/device combo is fraught with potential FDA delays.

Sounds easily fixable, which points to how screwed up this whole deadline-driven process is. Why weren't these issues raised earlier by the FDA? Or were they raised and brushed off by the company? Seems to me the EMA does this sort of thing better (or at least in a much more co-operative spirit).