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Posted On: 03/16/2019 4:03:35 PM
Post# of 72444
You are right Smokenhot
Problem with "off label" indications , it is harder and harder to get approved by FDA/EMA unless trial will do sub-group analysis after completion of the study and/or
study protocol will allow such patients to participate.
There is so many other reasons for development of OM ( rads alone , chemo alone , idiopathic ) and it would be shame not be able to use the drug in those situations .
My opinion only
Problem with "off label" indications , it is harder and harder to get approved by FDA/EMA unless trial will do sub-group analysis after completion of the study and/or
study protocol will allow such patients to participate.
There is so many other reasons for development of OM ( rads alone , chemo alone , idiopathic ) and it would be shame not be able to use the drug in those situations .
My opinion only
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