Expanded Access Policy

Oxion Biologics AB Expanded Access Policy

Purpose:

This Expanded Access Policy (EAP) outlines the strict guidelines under which Oxion Biologics AB, an early-stage biopharmaceutical company, might consider providing investigational drugs to patients who are not eligible for clinical trials and who have no satisfactory alternative treatments available. It is important to note that any expanded access would only be contemplated in the future once more is understood about the safety and efficacy of the drug.

Eligibility Criteria:

Patients may be considered for expanded access to investigational drugs provided by Oxion Biologics AB only if they meet the following stringent criteria:

  • Suffer from a serious or immediately life-threatening condition.
  • Have exhausted all available therapeutic options and are ineligible for participation in any clinical trials.
  • There is some indication, based on rigorous scientific evidence, that the patient might benefit from the use of the investigational drug. -The available data must suggest an acceptable safety profile for the specific condition and patient population.
  • Patients must be legally permitted to receive the drug under compassionate use, and Oxion Biologics AB must be able to provide the drug legally under the relevant jurisdictional regulations.

Application Process:

  1. Request Initiation: Requests for access must be initiated by a qualified treating physician, who must be licensed and compliant with local medical standards.
  2. Submission: Physicians must submit requests for expanded access to the designated contact at Oxion Biologics AB. These requests must include comprehensive medical justification, patient history, and relevant supporting documentation.
  3. Review: Requests will be reviewed on a case-by-case basis. Oxion Biologics AB will prioritize the integrity of its ongoing development programs and regulatory obligations. Decisions will reflect a cautious approach, given the early stage of the drug’s development.

Regulatory Compliance:

Oxion Biologics AB commits to full compliance with all applicable regulatory requirements in jurisdictions where expanded access might be considered. Approval or authorization from health authorities will be obtained as required.

Clinical Trial Data Sharing:

Physicians are expected to provide detailed reports on patient outcomes, which will help further our understanding of the investigational drug’s effects. This information is crucial for the ongoing development and evaluation of the drug.

Contact Information:

For more information or to inquire about future possibilities for expanded access, please use the contact form on www.oxionbio.com.

Revision and Review:

This policy will be reviewed annually and revised as necessary to reflect the evolving clinical and regulatory landscape and to ensure the highest standards of patient safety and ethical consideration.