Expanded Access Policy
Bicycle is committed to developing innovative new medicines for patients with debilitating diseases.
As part of that commitment, Bicycle conducts, alone or with our partners, clinical trials of our investigational medicines to seek to demonstrate their safety and effectiveness for patients. The data generated from these clinical trials are integral to obtaining regulatory approval of our investigational medicines and such trials represent the best and most efficient way to develop our investigational medicines.
Patients who choose to participate in clinical trials play an essential role in developing new medicines. Clinical trials, including eligibility criteria, are listed at www.clinicaltrials.gov. Patients interested in learning if enrollment in a clinical trial is an option for them should consult with their treating physician.
As a general policy, Bicycle will not provide Expanded Access* to an investigational medicine until sufficient safety and efficacy information has been obtained in clinical trials. Therefore, Bicycle is currently unable to offer Expanded Access to any of its investigational medicines, as Bicycle is committed to conducting formal clinical trials.
Bicycle may update this Policy at any time, consistent with applicable law and regulations. The posting of this policy shall not serve as a guarantee of access to any specific investigational medicine for any patient. This website and policy may be updated with a hyperlink or other reference to an expanded access record on www.clinicaltrials.gov after such record becomes active.
For questions or additional information about this policy, please contact firstname.lastname@example.org. Bicycle will endeavor to acknowledge any inquiries within five (5) business days of receipt.
* Expanded Access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Typically access is provided when a positive late stage trial has been reported or the Company has requested regulatory approval to go to market. Bicycle has no such products at this time and therefore it would be unsafe to offer such access.