Expanded Access Policy
Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives for the treatment or prevention of diseases that are inadequately addressed by current standard of care therapies. We conduct clinical trials to assess the safety and efficacy of our investigational new drugs. The establishment of the safety and efficacy of our investigational new drugs helps us obtain approvals from regulatory agencies such as the FDA. Regulatory approvals are required before these investigational new drugs 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 drugs prior to regulatory approval.
At this time, we will consider requests to allow patients access to our investigational new drugs 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 Cidara 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 Cidara has received the request, we will acknowledge receipt within two (2) business days and, once all required medical information is provided, Cidara will respond in no more than five (5) business days. Individuals interested in clinical trials sponsored by Cidara may visit www.clinicaltrials.gov for information on our ongoing clinical trials.
Cidara may revise this expanded access policy at any time. Additionally, the posting of this policy by Cidara shall not serve as a guarantee of access to any specific investigational new drug by any individual patient.
Dated: May 1, 2020