EARLY ACCESS

Patients facing serious illnesses and have exhausted all available treatment options often want to know if and how they can receive early access to investigational products that haven’t yet been approved by government regulatory agencies. NeOnc is committed to making its products available to patients, when appropriate, throughout the development process.

NeOnc believes participating in clinical trials is the best way for patients to access medicines before approval. In pursuit of NeOnc’s objective to develop highly effective and safe therapeutic approaches, the successful completion of a clinical trial program of investigational products is the most effective way of ensuring timely review and decision-making by government regulatory agencies. This will ultimately result in access to new, safe, and effective approved therapies for patients. For these reasons, NeOnc prioritizes access to its investigational products through active and accruing clinical trials and encourages interested patients to enroll.

Despite best efforts, all patients can’t participate in clinical trials. For that reason, NeOnc has established a Right-to-Try program to make promising products available to patients facing serious or life-threatening conditions. An eligible physician may request access to one of NeOnc’s investigational products by registering their practice/hospital on the AnovaOS™ platform at www.anovaos.com, searching for NeOnc, navigating to our Right-to-Try protocol, and applying for access under compassionate use. For help and support with the process, contact support@anovaos.com Note, when registering as a Research Site Representative, you will be asked whether you’d like to register additional personnel – please also register the eligible physician responsible for the Right-to-Try request.
Requests for further information about how to apply for Right-to-Try or determine qualifications and capabilities required to administer NeOnc investigational product can be made to compassionateuse@anovaevidence.com

NeOnc typically will acknowledge receipt of a request for Right-To-Try, with required medical documentation, within three business days. NeOnc professionals will carefully consider each request considering access to open and accruing clinical trials, the serious/life-threatening nature of the disease, biological rationale or clinical data supporting potential benefit medical appropriateness, and applicable laws and regulatory requirements. All physicians who receive NeOnc investigational product through Right-To-Try must comply with all applicable laws and regulations, and contractual conditions, including those related to safety reporting.

 

NeOnc’s Right to Try Policy can be found here.