SymBio`s Expanded Access Policy
What is expanded access use?
Expanded access (also known as "compassionate use") is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Expanded access may be appropriate when all the following apply.
- The patient has a serious disease or condition, or whose life is immediately threatened by his or her disease or condition.
- There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
- The enrollment of the patient in a clinical trial is not possible.
- The potential patient benefit justifies the potential risks of treatment.
- Providing the investigational medical product will not interfere with investigational trials that could support a medical product's development or marketing approval for the treatment indication.
What is SymBio's expanded access policy?
Brincidofovir is not currently approved by the United States Food and Drug Administration (FDA) nor any other regulator for any indication, except for the approval granted by the FDA for the treatment of smallpox. SymBio is committed to making brincidofovir available to patients in need as soon as possible through expedited clinical development. We are currently conducting a Phase 2 dose-confirmation clinical trial of the brincidofovir intravenous formulation (BCV IV) for pediatric patients with serious adenoviral diseases in the United States (ClinicalTrials.gov Identifier: NCT04706923). The efficacy and safety profile of BCV IV will be evaluated in a subsequent Phase 3 clinical trial. BCV IV may or may not be effective in the treatment of serious adenoviral diseases, and use of BCV IV may cause serious unexpected side effects. Therefore, BCV IV is currently only available through participation in the clinical trial and is not separately available through an expanded access or compassionate use program at this time.
Who can I contact to learn more about SymBio's expanded access policy?
If you have any questions about SymBio's expanded access policy, please contact us through inquiry page.
Can I submit an expanded access request?
Although BCV IV is currently only available to patients through participation in the clinical trial, if you would like to submit an expanded access request, please feel free to submit sufficient supporting detail to enable us to evaluate your request. Please also include your contact information so that we may follow-up with you directly.
In the event that we decide to consider expanded access requests for our investigational drugs, we will evaluate and respond to each expanded access request on a case-by-case basis.
When will I receive a response to my expanded access question or request?
We anticipate acknowledging receipt of any expanded access questions or requests within 3 business days of receipt.
Where can I learn about changes to SymBio's expanded access policy?
BCV IV is currently only available to patients through participation in SymBio’s clinical trial. However, this policy may be changed at any time. In the event that SymBio decides to make its drug available on an expanded access basis to patients not participating in the clinical trial, this policy will be updated with a hyperlink to the relevant expanded access record(s) on clinicaltrials.gov after such records become active.
Additionally, the posting of this or any updated policy by SymBio does not serve as a guarantee of access to any specific investigational drug by any individual patient.