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Question 1 of 3
1. Question
In order for a patient to be eligible for expanded access, the potential patient benefit has to justify the potential risks of treatment use and those potential risks are not unreasonable in the context of the disease or condition treated.
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Question 2 of 3
2. Question
The 3674 Form allows investigators to file an initial Single Patient Expanded Access Application as a licensed physician.
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Question 3 of 3
3. Question
The Sponsor’s responsibility is to maintain control of the drug and only administer investigational drugs to study subjects.
