Kleintje66 schreef op 27 augustus 2020 16:19:
Dit is ook nog wel interessant:
staat in: Study Protocol and Informed Consent Form [PDF] July 27, 2020
9.8 Charging for Investigational ProductBecause 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)
clinicaltrials.gov/ct2/show/NCT0445383