Biotech Values

[DewDiligence]

I'm guessing all they have is the orphan drug designation.

We know that there are no Makena patents in the Orange Book, so there presumably isn’t any IP for KV to assert against the compounders that would stand up to scrutiny. The point I was making in #msg-73443638, however, is that this matter is not the FDA’s concern; if non-Orange-Book Makena IP does exist, it’s up to the company (not the FDA) to take action.