Replies to post #16760 on Momenta Pharmaceuticals, Inc. (MNTA)

[Regulardoc]

Thanks.

Understand, but I was wondering why there would be a compliance issue with the 40 mg and not with the 20 mg. Would expect the manufacturing process to essentially be very similar, and given the compliance issue(s) with the 40 mg process, it appears that PFE has inconsistent processes in place and owns this big time.

[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.