Replies to post #112128 on Biotech Values

[DewDiligence]

FDA advisory panel votes 12-2 in favor of FRX’s aclidinium bromide for COPD:

http://finance.yahoo.com/news/Forest-Almirall-Announce-bw-2713059705.html?x=0

Forest and Almirall anticipate receiving FDA feedback on the filing in the second quarter of calendar year 2012.

Odd wording… is this when the PDUFA date is?

[DewDiligence]

FDA approves Tudorza Pressair from FRX/Almirall for COPD maintenance:

http://finance.yahoo.com/news/forest-laboratories-almirall-announce-fda-200000625.html

Tudorza Pressair (f/k/a aclidinium bromide) is a BID-dosed LAMA. How it will confer sufficient differentiation in the marketplace is unclear to me. FDA approval was expected insofar as an advisory panel voted 12-2 in favor in Feb 2012 (#msg-72477706).

p.s. The product name sounds like a centralized vacuum system that has been optimized for use in oversized Tudor houses.

[DewDiligence]

FRX—NDA submission for aclidinium/formoterol LAMA/LABA combination is delayed due to CMC issues:

http://finance.yahoo.com/news/forest-laboratories-almirall-decide-delay-200200379.html

Aclidinium bromide as a monotherapy is already FDA approved for COPD under the brand name, Tudorza Pressair (#msg-77786338).