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Label
Jun 27, 2014 14:40:15 GMT -5
Post by bradleysbest on Jun 27, 2014 14:40:15 GMT -5
Is this a good label?
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Label
Jun 27, 2014 15:07:49 GMT -5
Post by otherottawaguy on Jun 27, 2014 15:07:49 GMT -5
The shorter the label the better the label. They are also looking for the post marketing studies but these were already known that they would be asked for upon approval.
OOG
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Label
Jun 27, 2014 15:14:58 GMT -5
via mobile
Post by mrhaigs on Jun 27, 2014 15:14:58 GMT -5
I think it's totally fine. I'm happy with the label
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Label
Jun 27, 2014 15:22:05 GMT -5
Post by babaoriley on Jun 27, 2014 15:22:05 GMT -5
You don't mind the skull and crossbones?
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Post by alcc on Jun 27, 2014 15:28:43 GMT -5
Based on the news release thus far, sounds about as clean a label as can be expected (asthma, COPD, smokers). I am happy.
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Label
Jun 27, 2014 15:29:17 GMT -5
Post by mnkd2014 on Jun 27, 2014 15:29:17 GMT -5
Any one has an idea how this label is compared to the one Exubera got? Thanks in advance!
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Label
Jun 27, 2014 15:32:51 GMT -5
Post by liane on Jun 27, 2014 15:32:51 GMT -5
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Label
Jun 27, 2014 15:42:11 GMT -5
liane likes this
Post by mnkd2014 on Jun 27, 2014 15:42:11 GMT -5
Thanks, Liane. Really appreciate this board and your posts.
Quickly browsing through Exubera's label, I don't see any particular issue with AFREZZA's label. Look forward to any input from experts on this board.
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Label
Jun 27, 2014 15:47:05 GMT -5
Post by liane on Jun 27, 2014 15:47:05 GMT -5
The FDA announcement is not the complete label - but there won't be any surprises, just far more detail.
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Label
Jun 27, 2014 15:47:49 GMT -5
Post by mnkd2014 on Jun 27, 2014 15:47:49 GMT -5
From marketwatch.com:
"The FDA is making MannKind warn patients of possible bronchospasms for those with breathing conditions like asthma or COPD — chronic obstructive pulmonary disease. It also wants the company to remain in close contact with physicians to gauge how the drug is performing. The FDA will also require more trials for treating children and assessment of possible pulmonary cancer risks."
I don't see any surprise here.
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