MNTA -- FDA 6/9 plant approval and today's DDS release
You noted that NVS reported in its 2Q CC that the FDA found no deficiencies upon the 7/9 completion of its inspection of the Sandoz generic Lovenox plant in Austria. Do you know whether there any additional sites to be inspected and, if so, did NVS disclose any timetable for completion of inspections?
Based on today's DDS press release -- a complete response letter about 2 weeks after the FDA's inspection of the DDS manufacturing plant -- is it reasonable to assume that NVS could receive fairly rapid word from the FDA once all inspections are done.
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