Mylan (MYL): Biocon's Bangalore Facility Re-Inspections Likely Not Required, Observations Benign - Guggenheim
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Guggenheim analyst Rohit Vanjani weighed in on Mylan (NASDAQ: MYL) after they were able to FOIA the Form 483 issued to Biocon's Bangalore facility (attached) where biosimilar Neulasta is being manufactured and speak to a consultant regarding the observations.
"We previously provided different consultant perspectives without having the Form 483, where the feedback was that Mylan would still likely get an on-time approval," Vanjani notes. "After reviewing the observations in more detail and following up with a consultant, we are reiterating our view that a re-inspection likely is not required and that the observations are benign."
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