Saturday, August 09, 2014 10:56:47 PM
I spent some time digging to see if there were additional requirements behind the German Hospital Exemption that has not yet been shared or understood.
Translated Copy of the German Law Authorizing Hospital Exemption
The exact section pertaining to what is important for NWBO is on Page 25.
After spending some time reading and researching, I am still at somewhat of a loss. Wondering if someone would be able to help me with some of my own thoughts about the expansion below:
- Ensure the # of German patients are properly enrolled in the actual Phase III prior to signing up patients under the Hospital Exemption program.
- Fulfill other aspects of the German Drug Law that relates to Hospital Exemption no one is aware of.
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