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Re: Donald Hollinger post# 442

Thursday, 08/26/2010 12:54:25 AM

Thursday, August 26, 2010 12:54:25 AM

Post# of 22684
The first mention I know of was during the Q3 o9 Earnings CC:
http://seekingalpha.com/article/172573-arena-pharmaceuticals-inc-q3-2009-earnings-call-transcript?part=qanda

"Craig Gordon - Cohen & Co.

A couple questions, in the NDA Submission, do you guys plan on submitting proposals both for Phase IV commitments as well as a REMS program?

Bill Shanahan

We specifically discussed this issue with the FDA at our pre-NDA meeting and this will be a review issue, but at the present time we don’t see a safety signal to pursue, so we are going to continue to down evaluate our data filed with the NDA and then have discussions with the FDA after that."

Then in the q2 10 call the question and answer were both more specific. I can't locate a free transcript but if you listen to the webcast about 75% of the way in there is a good discussion about REMS and educational materials. http://www.shareholder.com/visitors/event/build2/mediapresentation.cfm?companyid=ARNA&mediaid=42978&mediauserid=4676807&TID=794935353:085ae12801c9b09268074ca763fc5852&popupcheck=0&shexp=201008260108&shkey=4d89e83e26320046479a86f5a1daf71f&player=1