9.8 Charging for Investigational Product Because

9.8 Charging for Investigational Product
Because sponsor is a small, venture-backed biotechnology company, sponsor plans to charge for investigational product. Consistent with § 312.315, Sponsor will charge for direct drug costs, costs of monitoring the expanded access protocol under § 312.320, complying with protocol reporting requirements, and other administrative costs directly associated with the expanded access use § 312.8(d)(2). Sponsor will further recover the fees paid to a third party for administering the intermediate-size patient population expanded access protocol, consistent with FDA’s interpretation of § 312.8(d)(2).
Sponsor will provide to FDA documentation to show that its calculation is consistent with the requirements of § 312.8(d)(1), describing recovery of direct costs and, if applicable, the requirements of § 312.8(d)(2), describing certain additional costs that may be recovered for intermediate-size patient population expanded access uses or treatment INDs or protocols.
This documentation must be accompanied by a statement that an independent, certified public accountant has reviewed and approved the calculations (§ 312.8(d)(3

Prot_ICF_000 (1).pdf

Study Protocol and Informed Consent Form [PDF] July 27, 2020