Replies to post #208067 on Biotech Values

[DewDiligence]

Re: MNTA /FDA guidance on interchangeable FoBs

Would you consider it neutral, positive or very positive for MNTA?

For starters, it's positive for MNTA that a draft of the guidance document has finally been issued after a long delay.

The content of the guidance doc is modestly positive for MNTA, IMO (based on my cursory initial scan of the document). The requirement for “switching” studies between the reference brand and the FoB was expected, so this element of the guidance is neutral.

What I find modestly positive is that there is no FDA requirement that an FoB sponsor first get approval for its FoB as a non-interchangeable product and then apply for interchangeable status in a separate (later) submission. I.e. MNTA wants its FoBs to be approved as interchangeable from the get-go, and this may be doable.

See the link in #msg-122395849 (and scan down) for related info.