Momenta Pharmaceuticals, Inc. (MNTA)

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MNTA: Momenta Pharmaceuticals' (MNTA) CEO Craig Wheeler on Q1 2017 Results - Earnings Call Transcript

Seeking Alpha

Excerpts re:40MG-

**In terms of the status of the resolution of the warning letter, Pfizer submitted their response to the FDA. We have reviewed the response and believe it is comprehensive and convincing demonstrating that Pfizer has already done a significant amount of work to address the observations. It’s important to point out that the observations and the warning letter relate to a May to June 2016 inspection and the warning letter was not received until February of 2017. Pfizer’s response not only confirms that they have already completed most of the commitment made to the FDA following that inspection, but that they are also diligently working to implement a comprehensive quality improvement plan to remediate any outstanding observations within this facility. Pfizer has also confirmed to Novartis Sandoz that the resolution of this warning letter remains a top priority for their company and they are working with the FDA to resolve any remaining concerns as quickly as possible.

Based on the work Pfizer has already done to resolve the observations and the warning letter and the effort Sandoz is putting forth to resolve the warning letter, we still believe there is potential for approval on launch of Glatopa 40 milligram in the 2017 timeframe.

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