Momenta Pharmaceuticals, Inc. (MNTA)

[Double_Bagel]

I think Craig said that they got verbal info of the rejection on Thursday, but they got written confirmation on Friday.

Craig seemed to hint that the problems were not related to the Glatopa 20mg/40mg production line, but that he couldn't disclose anything else at this time of where the problem was. He did say that the news seemed to come as a shock to Pfizer as they believed that they had addressed all the issues from the last FDA inspection in May/June 2016. There has been no inspections since then -- since FDA approval of GLATOPA or any other Pfizer drug does not always require a new FDA inspection. This was confusing. I think what he was saying was that if there were no inspections in May/June 2016 and no outstanding issues at that plant, there might have been a new inspection now for the GLATOPA approval??

This is all on Pfizer. They misled Sandoz and Momenta here. Some analyst did ask a question about the Pfizer / Synthon Glatopa collaboration. I am not sure of the exact question and I don't remember what Craig said in response.