Biotech Values

[DewDiligence]

I don't know if the FDA will ease up on Teva and give their application an approval. They haven't going on 7 years…

Nitpick: it’s actually closer to 7.5 years since Teva submitted its Lovenox ANDA. Teva notified SNY (then d/b/a Aventis Pharmaceuticals) of its Paragraph-IV challenge in Jun 2003, following FDA acceptance of Teva’s ANDA for review. Since the FDA generally takes several months to accept an ANDA for review, we may presume that Teva submitted the Lovenox ANDA in early 2003 or late 2002. (Note that Aventis submitted the original version of its Lovenox Citizen Petition to the FDA in Feb 2003.)