Momenta Pharmaceuticals, Inc. (MNTA)

[DFRAI]

Jbog

I read it twice and i dont believe there is anything that would indicate what action FDA will take on any pending applications.

The are stating that they have to follow the law and that while they may have looked or are looking at any requirements (such as gene expressions etc), they are not going to address the answer to a ANDA in a citizen petition answer.

Moreover, they went to great lenghts to tell TEVA that the studies and examples they brought forward do not deal with approved generic copaxone in the US and its pointless to make any inference as to the generic copaxone being proposed by MNTA.

Altough TEVA may file another citizen petition (8th), i feel that FDA may just deny it expeditiously...its a repeat of the previous seven CP.