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Re: groverisproud post# 4302

Saturday, 05/12/2012 2:38:44 PM

Saturday, May 12, 2012 2:38:44 PM

Post# of 22684
FDA spoke in defense on many issues for Lorcaserine. i.e.. safety, efficacy, tumors etc....just about everything.

The approval process is already in motion, first came a meeting that held the FDA, and Dr's from ARNA, and DR's on a separate panel that held different degrees. The FDA and ARNA since their last meeting discussed issues front he CRL from 2010. ARNA , THE FDA has laid all their cards on the table. Now the decision is up to the FDA. They will go over what was just done Thurs. and see if they are going to decide to approve or disapprove the drug Lorcaserine and if any REMS or not, labeling etc......

This can come 6-27 which is the current date set, or it can come earlier, or it may be delayed if the FDA needs more info or time ?

We all are hoping for one of the first two choices.....glty