InvestorsHub Logo
Followers 14
Posts 1160
Boards Moderated 0
Alias Born 12/19/2008

Re: Sprycel post# 9961

Wednesday, 02/25/2009 7:58:58 AM

Wednesday, February 25, 2009 7:58:58 AM

Post# of 58465
Genta has now met all of the requests from the FDA in order to receive approval of Genasense for the treatment of CLL, as specified by the FDA. The wording from the FDA was "not approvable in its current form" reads like it was an issue that could be addressed. Genta leadership met with FDA leadership to discuss the issue(s), then submitted the appeal.

The FDA has a 30 day response performance metric for submitted appeals. If it was a slam dunk NO, we would've certainly heard the response by now. The appeal was submitted in mid-December 2008. We're now at the end of February.

Please read slides 18 and 19 from the following link to get yourself up to speed on why the appeal was submitted by Genta leadership (may have to copy and paste):

http://webcastingplayer.corporate-ir.net/player/LrgPlayer.aspx?EventId=2079510&StreamId=1260249&TIK={8CEC9688-9089-484E-ABC1-DBB417AFD647}&RGS=1&override=lrg

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.