Replies to post #16809 on 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.

[floblu14]

Double bagel is correct. No problems with Glatopa 40MG just the Pfizer facilities & slow acting FDA -
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Aegis Capital analyst Difel Yang maintains Hold rating and $17 price target on Momenta Pharmaceuticals (NASDAQ: MNTA), noting the Pfizer (NYSE: PFE) facility problems impact the company’s supply chain for Glatopa, thus delaying upside potential.

Yang comments, "Warning letter delivered from FDA to fill/finish manufacturer. On Friday after market close, Momenta announced that Pfizer, Sandoz's contracted manufacturer for Glatopa, had received an FDA warning letter. While the facility is a key portion of Momenta's supply chain for Glatopa 20mg, the warning letter is not expected to restrict production or shipments. Since the Pfizer facility is where the final Glatopa 40 mg product will be manufactured, FDA policy states that compliance observations must be satisfactorily resolved before the ANDA can move forward. We anticipate this will translate into a 6-month delay for Glatopa 40 mg."

http://www.streetinsider.com/Analyst+Comments/Aegis+Capital+Reiterates+Hold+Rating+and+$17+PT+on+Momenta+Pharmaceuticals+(MNTA)+Despite+Supply+Issues+for+Glatopa/12571045.html