Biotech Values

[DewDiligence]

MNTA—In addition to the characterizations and assays performed by generic sponsors, FDA’s internal laboratory developed and performed its own testing of multiple batches of Copaxone, the proposed generic glatiramer acetate injection, glatiramer acetate-like products marketed outside of the United States, and negative controls, in each case using high-resolution analytical techniques.

This task presumably consumed a good portion of the 88 months during which the FDA had the ANDA.