Medlab Clinical receives human ethics approval for cannabis-based pain management medicine trial
Tuesday, 18 June 2019 Medlab Clinical Ltd (ASX:MDC) has received human ethics approval for the second trial of its cannabis-based medicine NanaBis™. Known as an Observational Study, the data from this study will be used to enhance regulatory package for potential drug approval. The trial will follow how Australian doctors use NanaBis, provide patient feedback and as a result will provide valuable data aimed to support its global regulatory efforts. The cost of the trial will be partly funded by successful participants as they will have access to NanaBis at a significantly reduced price. READ: Medlab Clinical signs second international distribution deal for NanaBis Medlab CEO Dr Sean Hall said: “This trial is very important to us as it allows MDC to leverage the Australian Special Access Scheme (SAS), follow the patients closely, but more-so publish and use the forthcoming data to bolster all our regulatory efforts as it relates to NanaBis. “In talks with a number of regulatory bodies, we were offered a unique ability to use this type of data in an effort to diminish the otherwise prescribed number of people needed to finalise drug application work. “This trial is happening in parallel to the almost completed Royal North Shore (RNS) trial. “With regards to the work at RNS, early data received is very pleasing and this coupled with the learnings from the current Australian SAS usage, NanaBis is a strong contender for pain management and in my mind a viable pain management medication.” Medlab expects to roll this trial out to 2,000 patients across Australia as quick as possible, making it one of the most significant cannabis trials to date.
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