Replies to post #199997 on Biotech Values

[genisi]

If the FDA directed that the EpiPen ANDA be resubmitted as a 505b2 NDA, I presume that Teva would have disclosed that.

Siggi Olafsson was asked about this possibility at Teva's Q3 2015 CC and answered:
"...our EpiPen was 505(b)(1) application, and it doesn't automatically switch into a 505(b)(2) overnight. There's no magic that can happen down in Washington. So my assumption is, and we still think we are going for a AB rated EpiPen, that's our strategy. And until I see what I get in the Complete Response Letter, I don't think -- I can't even speculate. But our application is for AB rated, not for non-AB rated."

http://www.thestreet.com/story/13345889/13/teva-pharmaceuticals-teva-earnings-report-q3-2015-conference-call-transcript.html

The CRL came after the Q4 2015 CC so, Teva should disclose the info next time...