Biotech Values

[DewDiligence]

New survey on FDA Approval of Generic Copaxone

Background: Teva’s Copaxone loses US patent protection on 5/24/14; the FDA’s GDUFA guidelines prioritize ANDA reviews for the first generic of a given branded drug and take into account the patent-expiration date of the branded drug. MNTA’s Copaxone ANDA was accepted by the FDA for review in Jul 2008 (5.7 years ago); MYL’s Copaxone ANDA was accepted by the FDA for review in Sep 2009 (4.5 years ago).

I’ve made the cut-off date for this survey 6/30/14 to allow for a little slippage past the patent-expiration date.


Q: On 30-Jun-2014, which of the following is the most likely scenario?

a) FDA has approved the ANDAs from MNTA and MYL.
b) FDA has approved the ANDA from MNTA only.
c) FDA has approved the ANDA from MYL only.
d) FDA has approved neither ANDA.


To vote, please go to
http://investorshub.advfn.com/boards/board_surveymenu.asp?board_id=1418
and select surveys #157.