Biotech Values

[DewDiligence]

The inferences to be drawn from FDA inspection of production facilities are asymmetric: i.e. the lack of FDA inspections implies that approval is not near, but the inspections per se do not imply that approval is near. There have been myriad cases where the FDA inspected an applicant’s plants and ended up not approving the drug in question on the current review cycle.

The Chinese suppliers of the bulk heparin that is used to manufacture both Lovenox and UFH have been inspected by the FDA as part of the fallout from the 2008 contaminated-heparin crisis. Thus, it’s almost certain that Teva’s suppliers of bulk heparin have been inspected by the FDA independently of Teva’s Lovenox ANDA.

Bottom line: If the response you got from the analyst is accurate, it removes one piece of evidence that Teva is not close to approval. It does not however, imply that Teva is close to approval.