Momenta Pharmaceuticals, Inc. (MNTA)

[10nisman]

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.

Is there no way to move the 40mg Glatopa to the 20mg Glatopa lines? 40mg is going to drive the vast majority of sales going forward so NVS/MNTA can essentially dump the 20mg lines for now.