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Re: scstocks post# 147

Monday, 10/13/2008 6:03:48 PM

Monday, October 13, 2008 6:03:48 PM

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I have been in other drug companies, and not all of them have had advisory panels for their products. I am not sure why some have advisory panels and others don't. Usually the FDA will follow the recommendation of the panel, either Yea or Nay and other advice like for more trials or certain warnings. There is the occasional exception where the FDA does not follow the advice of the panel. One big example is CRME, where they had the advisory meeting last December which voted for approval of their product with the PDUFA date in March, but after continuos delays they finally issued an "approvable letter" this past July. Still, December 10th is going to be a BIG day for us. Which ever way they vote, I would say would give us an 85% chance of that being the decision by the FDA. If memory serves me right, we new the vote of the advisory panel on CRME last year within 1 week of the panel date, so I assume it will be the same thing with ACUS.

"You don't want to sell me death sticks, you want to go home and rethink your life." Obi-Wan Kenobi


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