Replies to post #107793 on Biotech Values

[DewDiligence]

This boils down to a question of credibility. One year ago on Teva’s 3Q09 CC, Bill Marth said Teva was in “labeling” discussions with the FDA about generic Lovenox. Here's the CC transcript from November 3, 2009:

http://seekingalpha.com/article/170936-teva-pharmaceutical-industries-limited-q3-2009-earnings-call-transcript?part=qanda

Ken Cacciatore (Cowen): “…could you give us a regulatory update on Lovenox, for both you if you’re aware of anything surrounding your competitor?”

Bill Marth: “Yes, Ken, good morning… I wish, I had a crystal ball and could tell you exactly that when that approval comes and I can’t really comment too much for the other players in the market. I’m not sure where Momenta is right now and I’m not sure about Amphastar. What I do know is that we see application progressing very nicely. We’re getting very normal questions back around labeling and all of the typical stuff. So we do see activity and very positive activity.”

I’ve never heard of a case where labeling discussions for an FDA drug application persisted for more than a year.