in each case beginning with the 510k approval process
in each case beginning with the 510k approval process with the FDA expected to commence during the early part of 2019
510K approvals and launch of new products costs money. Collectively about $2 million per product and that is only because KB's development and regulatory team take their direction directly from him and not from costly engineers, chemists and high paid consultants. What KB is doing is not the way the industry operates. What KB is doing is not what penny stock traders expect and he is often condemned for being a good manager with great vision.
As shareholders we are getting a huge bargain. A bargain that has traded short term stock price for in return the building of a foundation for an eminently salable group of similar proprietary technologies. KB was able to see, even though it was right in front of the industry for a decade, how to take the industry's most venerable technology, and in one swell foop turn this venerable technology into the medical device industry's equivalent of a hybrid car. Think about goals. So the big question is, why hasn't the medical device industry, lead by 4 huge pharmas not threaded this needle? Because .... they didn't think about the fastest and inexpensive way to accomplish the goal. They instead took direction from development engineers, clinical chemists and high priced consultants and created more expensive but only slightly better mousetraps.
Therefore the Reg A1.
By the way, if memory serves, Lifescan's response to DECN's laser beam blast against the ruling by the Vegas judge is due tomorrow.
3
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