Replies to post #208069 on Biotech Values

[DewDiligence]

MNTA’s phase-3 trial for Humira FoB had FDA–mandated switching:

Consistent with the draft FDA guidance on interchangeable FoBs that requires switching patients back and forth between the branded drug and the FoB without clinical harm (#msg-127909952, #msg-127915407), MNTA’s phase-3 trial for M923 (its wholly-owned Humira FoB) had a switching arm—the third arm in the clinicaltrials.gov listing:

https://www.clinicaltrials.gov/ct2/show/NCT02581345

The use of switching was also confirmed in MNTA’s 11/29/16 PR (link in #msg-126858164):

This was a confirmatory, randomized, double-blind, multicenter study evaluating the efficacy, safety and immunogenicity of M923 in adult patients with moderate-to-severe chronic plaque psoriasis. Patients received up to 48 weeks of treatment with M923, HUMIRA, or HUMIRA alternating with M923 [emphasis added].

So, it would appear that MNTA is all set wrt the switching requirement in the new FDA draft guidance.

[Bickema]

MNTA's stock price seems to be reacting negatively to this guidance. Is this a general misunderstanding by investors who do not fully grasp MNTA's biosim capabilities in your opinion?

Would a good way to put this in Lehman's terms be that the bar is higher but the pay off is higher and that in theory this will weed out MNTA's weak competitors while solidifying their strong IP?