Biotech Values

[DewDiligence]

We know the FDA can be fickle and unpredictable and so it is quite believable for me that [Teva] ran into some last-minute FDA objection of unknown seriousness.

I would respectfully suggest that you are spectacularly (there’s that word again, LOL) wrong on this point. As far as I can tell, once the FDA published the minimum requirements for approval of generic Lovenox, Teva realized that it didn’t have a snowball’s chance in hell of getting FDA approval.

Initially, Teva reacted by stepping up the propaganda machine (#msg-66755361); however, Teva found that such propaganda, while possibly annoying to MNTA, wasn’t doing anything of consequence to help Teva. Then, in Dec 2010, MNTA filed its patent-infringement lawsuit, forcing Teva to revisit the idea of waging a war of words. Following careful deliberation, Teva concluded that the Lovenox ordeal was an embarrassment to the company and the best thing Teva’s executives could possibly do to restore credibility was to say nothing.

If the [FDA’s] objection [to Teva’s ANDA] is terminal, I doubt they would announce that fact - they will just leave MNTA in limbo, albeit piling up the dollars.

Bingo.