Thanks for question. I meant to state that obtaining a 510(k) market clearance from FDA for a topical wound dressing is generally not very difficult. The wound dressing sector is a crowded and price senitive field because many such products have received FDA clearance for marketing. We don't know if ARTH has proposed any novel claim language, but normal label claims are not super difficult to obtain. So obtaining a 510K clearance is not a great success that will automatically add value to the company.
I was raising the issue about whether the device - if eventually cleared as a topical wound dressing - is saleable in a volume that would be significant financially. It seems that people are assuming that FDA clearance will translate into a market and financial success, and the financial success will be able to fund development of a more significant device. These may be unsupported assumptions. There has been no marketing or distribution plan presented, and neither the CEO nor any board memebers have successfully launched such a product in the past.
I raised the issue in an earlier post that the CEO drew compensation of $1.2 million in cash & stock compensation in 2017 for leading a prerevenue company (as reported to SEC in 10K filing), and that directors are receiving cash compensatiuon as well. This is highly unusual. However, rather than focus on likely shannigans, I tried to focus my comments on the business fundamentals. The current focus on a topical wound dressing for AC5 technology doesn't seem to lead any where positive. If the wound dressing isn't successful, then what?
