Replies to post #6297 on Momenta Pharmaceuticals, Inc. (MNTA)

[investorgold2002]

" attained proof of sameness on Nov 2, 2007"

Is this just Ampha's claim ? or did actually FDA state you met our 5 criteria (which they published 3 years later!)

I think even FDA did not know those 5 criteria until much later as they got convinced by MNTA's ANDA towards its approval ?


You know what let me recall my message...The Date of Nov 2 2007 makes me feel at the time FDA had probably signed off on sameness...and maybe they added a new criteria later?

[investorgold2002]

OSCS

It will be interesting to know how Ampha tests for OSCS in its starting material. MNTA has a patented way of testing for it

see item 52 page 9

[OakesCS]

jbog,
the filing date of the patent is relevant and the filing date on the 886 patent was 03/11/2003.
regards,
Charlie