SCYNEXIS development resources are focused on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of our investigational products, and to obtain regulatory approval.
SCYNEXIS is committed to making investigational products available to seriously ill patients who have exhausted other treatment options. A treating physician, who is able to comply with the requirements that are stated in this document, may request information about how to apply for access to SCYNEXIS’ investigational products by contacting the Company.
The purpose of this policy is to describe the requirements for Expanded Access to SCYNEXIS investigational products to patients outside of a clinical study.
This policy applies to provision of access to a SCYNEXIS investigational product that is not approved for any purpose in the country from which the request is intended to be used. This also includes the time period between regulatory approval of an investigational product and its commercial availability in a country.
Any use of a SCYNEXIS investigational product outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including SCYNEXIS policies and procedures.
In general, where permitted by local regulation, the investigational product supplied via Expanded Access may no longer be provided by SCYNEXIS when it becomes available via the local healthcare system.
SCYNEXIS may decide not to provide an investigational product under this policy if the Company does not intend to market the product in the country.
A. Patient Eligibility Criteria
To be eligible for access to an investigational product, patients must meet the following criteria:
B. Investigational Product Criteria
In addition to the patient eligibility requirements, the investigational product must meet the following criteria:
C. Treating Physician Criteria and Responsibilities
The physician(s) attending to the patient(s) who is/are receiving an investigational product through compassionate use access is (are) properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with:
A treating physician may submit questions or requests regarding expanded access to email@example.com.