Cellics Therapeutics is a clinical-stage biotechnology company focused on the development and commercialization of novel live biotherapeutics for the treatment of chronic kidney disease alongside current standard of care therapies. We conduct clinical trials to assess the safety and efficacy of our investigational new products. The establishment of the safety and efficacy of our investigational new products helps us obtain approvals from regulatory agencies such as the FDA. Regulatory approvals are required before these investigational new products can be made generally available to patients. We encourage awareness of our clinical trials and believe that participating in clinical trials is an appropriate way for physicians and patients to access investigational new products prior to regulatory approval.
At this time, we will consider requests to allow patients access to our investigational new products prior to FDA approval on a case-by-case basis, using pre-established criteria to assure a comprehensive internal review process which may not result in access for all requestors. Physicians interested in requesting expanded access on behalf of their patients may contact Cellics Therapeutics at email@example.com. Requests should include a brief de-identified patient history and the reason why treatment is being requested for the patient. Once Cellics Therapeutics has received the request, we will acknowledge receipt within thirty (30) business days. Individuals interested in clinical trials sponsored by Cellics Therapeutics may visit www.clinicaltrials.gov for information on our ongoing clinical trials.
Cellics Therapeutics may revise this expanded access policy at any time. Additionally, the posting of this policy by Cellics Therapeutics shall not serve as a guarantee of access to any specific investigational new product by any individual patient.