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Fly News Breaks for December 20, 2018
IMMU
Dec 20, 2018 | 11:14 EDT
Morgan Stanley analyst Matthew Harrison spoke with Immunomedics management following a short report being published and noted that the company indicated that issues the FDA communicated in a Form-483 were discovered as part of a ramp to GMP quality in late 2017 and early 2018. Management also said they'd begun remediation of the issues "well prior" to the 483 receipt and have worked to remediate all the key issues. He appreciates the concern in the market, given that investors have been worried about manufacturing issues potentially impacting the approval of IMMU-132, but Harrison still believes there is a higher probability of approval than not on the PDUFA. He keeps an Overweight rating on Immunomedics shares with a $38 price target.
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