Medlab Clinical announced the US Food and Drug Administration (FDA) has granted clinical Investigational New Drug (IND) status for its lead candidate NanaBisTM. The approval allows Medlab to initiate its pivotal Phase III trial at US sites and is an important validation of the strong safety and efficacy data supporting the NanaBisTM program. NanaBisTM comprises of CBD:THC (cannabis-based medicine) formulation optimised by Medlab's proprietary delivery platform, NanoCelle®. The Phase III trial will investigate NanaBisTM as a monotherapy for the most common type of cancer pain, metastatic cancer-induced bone pain (CIBP) i, as its first indication, with the possibility to expand the market opportunity to all cancer-related pain following regulatory clearance. Currently, NanaBisTM is the only cannabinoid-based pharmaceutical under development for cancer pain initiating Phase III trials in the US. The current standard of treatment for cancer-related bone pain includes opioids, which have shown to be ineffective in many cases. There is a high unmet need for a non-opioid pain alternative that is safer and more effective. The IND grant submission to the FDA includes robust data generated from the Company's Phase I/II trial which was completed in March 2020 and met its primary and secondary endpoints. Also included was supporting data from Medlab's real world observational study, which is presently showing a 55% reduction in pain together with improved quality of life outcomes. With this acceptance, the US joins the UK and Australia as approved Phase III trial jurisdictions. In the UK, the National Institute of Health Research (NIHR), one of the world's leading healthcare research organisations, announced its support as a strategic stakeholder in the UK arm of NanaBisTM Phase III trials. In upcoming months, the granting of IND status will see: Lodgement Medlab's Phase III clinical trial to clinicaltrials.gov; FDA and Drug Enforcement Administration (DEA) release scheduling recommendations for NanaBisTM; DEA is expected approve NanaBisTM for shipping to the US in preparation for the trial to commence; First introduction of NanaBisTM into US market. In the US, the Company has made a second IND submission for Expanded Access, which if successful, will enable compassionate use sales in the US to commence.