Biotech Values

[DewDiligence]

MNTA re: Completed FDA facility inspections

You noted that NVS reported in its 2Q CC that the FDA found no deficiencies upon the 7/9/09 completion of its inspection of the Sandoz generic-Lovenox plant in Austria. Do you know whether there are any additional sites to be inspected…?

There are no remaining inspections to be done. The FDA completed its inspections of the Sandoz plant in Austria and the four suppliers of bulk heparin in China. No Form-483’s were issued at any of these sites.

Based on today's DDSS press release -- a complete response letter about 2 weeks after the FDA's inspection of the manufacturing plant -- is it reasonable to assume that NVS could receive fairly rapid word from the FDA once all inspections are done?

Possibly but not necessarily. The key distinction between the two cases is that the DDSS application is an NDA while the NVS/MNTA application is an ANDA. As you probably know, ANDA’s do not have prescribed timelines.