This policy applies to expanded access, also called “compassionate use” requests for investigational products that have not been approved in any country. For purposes of this policy, an expanded access use request is any request for the use of the investigational product outside the scope of a clinical study. This policy is intended to comply with the provisions of Section 561A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-0).

Glycomine is committed to developing novel therapeutics for patients suffering from rare and seriously debilitating diseases. Our development resources are currently focused on conducting clinical studies and obtaining regulatory approval of our investigational product GLM101 for the treatment of patients with PMM2-CDG. Glycomine does not have an Expanded Access Program at this time and is not accepting or considering requests for expanded access.  Should Glycomine develop an Expanded Access Program in the future, this policy statement will be updated. Additionally, the posting of this policy does not serve as a guarantee of access to any specific investigational new drug by any individual patient.  If you have questions, please contact info@glycomine.com.