Obtaining a FDA 510(K) premarket clearance for this class of device is not that difficult; many small companies have been able to obtain a 510(k) clearance for this class of device. So the question that "cuts to the bone" for ARTH is, what will ARTH do with the AC5 wound dressing once it receives the marketing clearance? Do we have a forecast or even a range of forecasts of revenues for US product sales in 2019? Does anyone have a hint of what the gross margin might be? I assume that ARTH will be successful with FDA; I am less sanguine about market success for the product, espcially in light of no forthcoming information about how ARTH is preparing to sell and distribute this product. Does anyone have any information on these topics? If so, please post.
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