The above are general requirements, and specific requirements will be applied for a given investigational drug or clinical program if and when Prothena initiates an expanded access program.
Note that investigational drugs have not yet been approved or cleared by regulatory authorities and regulatory authorities have not found these products to be safe and effective for their specific use. Furthermore, investigational drugs may, or may not, be effective in the treatment of the applicable condition, and use of such investigational drugs may cause unexpected serious side effects.
Patients should consult with their treating physician about their eligibility to enroll in any of Prothena’s clinical trials. To get more details about Prothena’s clinical trials, please visit the “Clinical Trials” page on Prothena’s website or on www.ClinicalTrials.gov. If you are a physician who has questions about Prothena’s investigational therapies, please contact us at email@example.com.
The publication of this policy by Prothena is not a guarantee of access to any specific investigational drug by any individual patient. Prothena may revise this expanded access policy at any time.