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clock Created with Sketch. 30/04/18
10:11
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Originally posted by jasetheace40
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A very thorough and objective appraisal of what the recent BodyCare trial results mean. Clearly this is a major project now."BodyCare’s score of 2.2 for movement pain VAS and 3.4 for resting pain VAS places it in the upper region of all product efficacy set out in Oxford League Scale, including oral and opioid options. What are the paths forward to the market? Any potential partner will only engage with OBJ if there is a strong focus on getting the BodyCare product to the US market. This requires the product to be regulated by the FDA. In the case of BodyCare there is potential it could follow either an OTC or an Rx pathway depending on the type of pain and duration of treatment. This is likely to mean that a new drug application (NDA) for both paths must be filed. Less is known about topically-delivered ibuprofen than the orally administered variety, although the results of this trial suggest a favourable safety profile. Any NDA would likely require determination of the minimal effective dose, and overall there would be further analysis required to provide the necessary data around safety and efficacy at various doses. Strategic decisions regarding the target indications are also an important factor moving forward, with risk-reward scenarios to be factored in. These are decisions that would need to be made by OBJ prior to moving forward and electing to either ‘go it alone’ or collaborate with a strategic partner. There is still significant work required in bringing this product to market, including finalisation of the product form, optimising formulation, completing safety studies and all required efficacy studies in the chosen indications. However, as noted by Dr Meller, whilst the time and cost is significant this is offset by the size of the prize, and the recent trial results put OBJ in good stead to pursue this. The initial pilot data suggests this product could potentially provide similar efficacy to oral-dosed NSAIDs (including oral ibuprofen) without the adverse GI and CV sideeffects, and be able to so with a much lower dose. This would have significant implications for the product as an acute treatment for musculoskeletal pain in the OTC market. Alternatively, the product may also [needs to be evaluated] provide an alternative to opioids in treating long-term chronic musculoskeletal pain, again while having none of the CV and GI side-effects of NSAIDs and none of the addictive potential for opioids. While this is a much longer and costlier path to market, which includes long-term studies, there is potentially greater upside. Partnering activities Since the completion of the IBU study, OBJ has been engaged in discussions with potential partner companies as well as exploring a ‘go it alone’ strategy to develop Bodyguard as a new, stand-alone brand. The Board will consider all options before determining the best strategy for the company in this key business category."
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Company acknowledges that any potential partner will want USA distribution. So as soon as you mention FDA it's years away and at great expense.
(20min delay)