Revive Therapeutics Ltd C.RVV

RE:RE:RE:RE:RE:RE:News - Submits for IRB Approval w/ FDA

[PowerofNow]

What is an IRB? An institutional review board is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. According to the FDA’s website, ‘the purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.’ Exploring FDA Expanded Access Program The company also announced that given the pandemic and urgency for new treatments, they will be exploring the FDA Expanded Access Program (aka Compassionate Use Program). The Expanded Access Programs provide patients with a path to receive an investigational drug for a serious disease or condition. These investigational drugs are often made available when there are no comparable or satisfactory alternative therapies to treat the disease or condition, where patient enrollment in clinical trials is not possible, the potential patient benefit justifies the potential risk of treatment and when providing the investigational drug will not interfere with clinical trials that could support the drug’s marketing approval for the treatment indication.