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Re: 10nisman post# 16809

Tuesday, 02/21/2017 11:04:33 AM

Tuesday, February 21, 2017 11:04:33 AM

Post# of 20689
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