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01/31/11 1:47 PM

#5381 RE: DonShimoda #5380

It's pretty incredible. I cannot believe it still takes that long to get a capable drug into the hands of non-trial patients.

In terms of getting a marketing panel together to approve a drug, is the FDA really that backlogged where they set a meeting date 6-9 months away from NDA application? It seems like bureaucratic B.S. to me.