LaNova Medicines Limited

Expanded Access

• We understand the interest of patients in accessing LM-108 and other novel investigational medicines outside of clinical trials and prior to regulatory approval for potential life-threatening diseases, however we do not currently offer Expanded Access Programs for our investigational medicines as all of them are still in early phase clinical stage.
• In very rare and specific circumstances, patients with serious or life-threatening disease may still need access to our investigational medicines. Please consult with your physician, the requests will be reviewed with our physician case by case. Several important medical and logistic criteria need to be met including:
• The disease is serious or life-threatening;
• All other available alternative therapies have been exhausted, but the patient may still benefit from further treatment with an investigational medicines;
• A clinical trial is not available, either because patients are ineligible or because they have no access to the trial;
• The efficacy and safety data available at the time are of sufficient strength to determine whether the benefit to the patient would likely outweigh the potential risks; and
• Access is compliant with all applicable laws and regulations.
• There is an adequate supply of the investigational medicine in local.
• There is an ongoing clinical trial in local which can support the investigational medicines distribution.
• Regulatory requirements have been completed based on local IRB requirements, such as compassionate use.