Replies to post #113126 on Biotech Values

[iwfal]

MNTA and TEVA - I think the general consensus on the board was that impurities (and associated consequences like immunologenicity) were likely to be one of the hang-ups in the Teva ANDA. And per the list provided by HPT that would fall under Major Deficiency:

Responses to the following examples of deficiencies would result in a major amendment. This should not be considered an all-inclusive listing.

1. Manufacture of a new batch of drug product (with supporting information) for any reason; for example:

• Composition change or reformulation

• Change in the source of a drug substance

• Change in manufacturing site

• Need for a new bioequivalence study (21 CFR 320.21)

• New in vitro study for a specific product (e.g., metered dose inhalers)

• Change in major manufacturing process

• New strength of the product

• Unacceptable impurities or impurity levels (21 CFR 314.94(a)(9))

• Unacceptable excipients found during the review (21 CFR 314.94(a)(9))

Other questions:

Did Momenta get any Minor/Major Deficiency responses from the FDA - how many? And with what timing relative to the major events we know about? (E.g. was the request for immunologic data part of a minor or major deficiency letter? Were there any subsequent such letters?)