Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

Why 20mg Glatopa is not affected:

If Pfizer is involved with the 20 mg dose and if it is being done at the same facility, you have to wonder what the heck is going on here as I would assume the process should be similar.

The answer is that the compliance issue has nothing to do with either version of Glatopa.

As a matter of policy, the FDA does not approve a product where there is an unresolved compliance issue anywhere in the product's supply chain, so the approval of 40mg Glatopa has to wait until the compliance issue is resolved. However, FDA policy does not automatically force the suspension of a marketed product just because it uses a facility with a compliance issue, so sales of 20mg Glatopa are not affected.