Replies to post #16638 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

If MNTA’s 40mg ANDA is being held up due to the design of the syringe, CW has been misleading investors. Here’s an excerpt from the 2Q16 CC:

http://seekingalpha.com/article/3995954-momenta-pharmaceuticals-mnta-ceo-craig-wheeler-q2-2016-results-earnings-call-transcript?part=single

CW: In terms of the [40mg Copaxone] review, the only difference here is it’s a different formulation… It’s the same API and we have a drug master file on API. So what they are looking at here is the formulation, which there are elements to review certainly in the formulation, but this is not a radically different formulation, it’s a different concentration.

Umer Raffat (Evercore ISI): I would have thought, it’s just a higher dose. So, there wouldn’t be any difference in formulation.

CW: Well, formulation includes the concentration of the API. So, that’s why it’s by definition a different formulation.

Umer Raffat: But everything else is the same?

CW: Yes.

[floblu14]

This has to be the holdup....

Sandoz has its own REGISTERED injectable device for the 20MG. With their expertise, a similar tool for 40MG has most assuredly been developed & passed FDA standards.

Here's the 20MG GLATOPAject -


See also -
http://www.glatopa.com/glatopa_care/injection_training.shtml

http://www.glatopa.com/cs/www.glatopa.com/assets/PDF/Glatopaject-Instructions-for-Use-c.pdf