Momenta Pharmaceuticals, Inc. (MNTA)

[jbog]

Tony,

You have to understand the type of violation that Pfizer was caught with to try to understand of the 're-inspection' goes.

Let's say there are two types of violations that can happen:

1) The wall needs painting because chips are falling off.

2) The wall needs washing because your CGMP policy says it needs to be washed twice a day and it hasn't been washed in 6 months.


In violation #1 the FDA would simply comeback , see the wall is painted and sign off of the deal. In violation #2, the FDA has lost all faith that you are following your own policies. You might wash the wall today, but does that mean you'll continue to wash it twice a day as your spec says?

The FDA has lost complete faith that Pfizer will perform as promised, so how long will it take the FDA to gain Faith in the organization.

Sandoz/Momenta were stupid not to have a back up finish/fill contractor as a safety valve just for the 20mg market. Absolutely Stupid.