Replies to post #210452 on Biotech Values

[DewDiligence]

Re: MNTA /interchangeable FoBs

I thought the trial duration was too short (52 weeks) to incorporate that quantity of switches.

52 weeks in toto seems like plenty of time to do the required three switches, allowing three months of dosing between each switch.

There is a need for a full PK, PD, and immunogenicity sampling done after each switch, which I thought you would need a decent time for a washout to the previous treatment to be valid.

That’s not practical, and I don’t think it’s what the FDA is looking for. When switching is done in patients—as opposed to healthy volunteers—you cannot ethically have a washout period. PK/PD bioequivalence is shown in a separate study (which MNTA conducted for M934), and it is not the impetus for switching.

Hope you’re right because it doesn't pass the smell test to me.

That’s what makes a market! (As far as I know, you’re not currently long MNTA, but I am.)