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3,253 Posts.
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27/06/12
22:51
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Hi Disc,
At this stage Iam down a fair amount as well ,thing is I can afford it.
As for Smith Barney I can't post the report as its against Hc rules.
Main points.
Major surprise as the combination rule was always considers a formality.
Until august meet no idea what the issues actually are.usually they are laid out in the response letter.there not.
Company will submit study 22 which is the respirtory depression study if safety is the issue.It did not get submitted in the nda.
60 percent are approved after receiving such letter
My personal view is ,this is a enormous market , with some of the worlds biggest companies involved.Not easy to get a piece of the pie this easy.
A bit more work is needed.
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