Biotech Values

[DewDiligence]

Re: AMGN’s advisory panel /MNTA

Isn't that a negative for MNTA?

The existence of AMGN’s Humira-FoB program is a negative for MNTA, who is also developing a Humira FoB (with SHPG); however, today’s advisory panel vote per se is not a negative for MNTA, IMO.

I question why FDA advisory panels are even needed for most 351(k) applications. Panels like today’s (where the vote was 26-0) are a pretty big waste of time, as far as I can tell.