Biotech Values

[jq1234]

Thanks for the link. This came from the most recent Teva Citizen Petition regarding generic Copaxone filed in Dec2013:

http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;D=FDA-2013-P-1641

Compare to previous one filed in Jun2012 and denied in Dec2012:

http://www.regulations.gov/#!docketDetail;D=FDA-2012-P-0555

Per Dec2012 FDA denial letter:

https://www.dropbox.com/s/i5ihpsiilw1smsu/Photo%20Mar%2009%2C%203%2041%2054%20PM.png

It seems FDA is ready to rule in near term, maybe on or before required date when FDA have to respond to Teva current Citizen Petition.

The most interesting part of presentation to me is Teva analyzed generic Copaxone launched in India, Mexico, Argentina, but unable to obtain versions currently under FDA review. I would assume similar/equivalent methodology could have already been used in MNTA's version in support of ANDA filing and review.