Replies to post #13347 on Momenta Pharmaceuticals, Inc. (MNTA)

[vinmantoo]

MTB, it sounds lie you have hit on somehtgn very imprtn.

Dew, as far as NATCO saying they have altered their product, it sounds like they had to change it. The big question is do they now show batch to batch reproducibility and similarity to Copaxone and mCopaxone.

[DewDiligence]

I’d like to be able to agree, but I’m not sure that court document from 2013 is probative. MYL may have received a CRL and reworked the product since the sample cited in the court document was produced.

I’m relying more on MNTA’s confidence on today’s CC vis-à-vis their Copaxone manufacturing patent being able to keep competitors off the market. Reading between the lines… it seems that NVS/MNTA have found a way of circumventing the Safe Harbor argument used by Amphastar.