"The $2 million was for foundational technology that simply needed to be tweeked to the latest generation of the One Touch family it was using as a Predicate base."
No it wasn't. The $2 million was for the 510K and the marks. More likely it was supposed to be a good bye payment to Shasta. Then Shasta got into terminal trouble with the FDA and that damaged DECN. You were a shareholder of DECN in 2014, right? Then Shasta screwed you too, big time and many times. Why is Shasta your white knight? And why do you downplay the work needed to design a test strip for a meter family where you do not have or own the blueprints.
Well that's not the credit KB gave them in his 2011 3rd quarter report.....
" Genstrip is a product conceived and designed by Shasta Technologies LLC, fits into a diagnostic product niche and sell into an estimated 2011 world-wide market of $24 billion. The company has been involved with Genstrip since early 2010."
Shasta submitted Genstrip to the FDA in December,2010.
I completely agree w/r to Shasta. I have no fondness for them,I simply know they are a piece of the puzzle. The fact Cal got busted in his home for trying to run a Business out of it goes to a level incompetence that is beyond me. December of 2013 no less. Wasn't KB aware Shasta didn't have any facilities other than a lawyers basement? And they thought maybe $200 mil in the first year...when Shasta was operating out of a residence's basement?
I didn't downplay KB's input. I simply said Shasta had the original technology. This "borrowed technology" as we now refer to it as(where this came from,I'm not sure...Shasta acquired it most likely? or did KB acquire it somehow and apply it to the Shasta base IP at a later date?) is the common thread to all this,it is not the exact technology of One Touch...but it's so core/common to everything(both products),that you can make a slightly altered product that passes a 510 for the original.
How incline hooked up with ? is a fascinating part of the story. Incline had all kinds of IP that was targeting JNJ(Fastcheck,etc). But your right,The 2001 Onetouch Ultra Plasma calibration technology is the one we're specifically discussing here w/r to predicate for Genstrip.
But it begs to be discussed, how much has the Onetouch strip really changed? Unistrip got approval for a One Touch Ultra 510 predicated on the original 1992 One Touch strip. So, did Cal get the secret recipe at some point and add it to inlcine's 3544 predicate to get a 2134 510 .....????
"The Shasta IP apparently goes back to Selfcare origins(K002134),and incorporates the borrowed technology that is the common thread amongst these platforms.
"Selfcare was the owner of the predicate device. Selfcare itself was a creation of Inverness (Scotland). Both Inverness and Selfcare operating in Massachusettes in the U.S. were owned by J&J as early as 1998 or 1999. That was the heyday of medical and biotech public spinoffs. In the U.S. both Inverness and Selfcare were Amex companies until J&J subsumed them."
And before that,Medisense,which was bought by Roche. So yes,it is a small world.
A predicate device means -- who did you pattern your technology after. Not who you borrowed or took it from. It is an anachronism of the 510k process. It doesn't mean that technology was acquired or anything like that. In Shasta's case they chose the OneTouch FastTake as their predicate. FastTake was so flawed, perhaps the most flawed product ever to be commercialized, that J&J had to redesign the FastTake into OneTouch Ultra. Between 1996 and 2002 J&J had a rapid succession of 510Ks approved by the FDA for essentially the same product. So after learning about the proposed Shasta product, I had no problems with the choice of FastTake as the predicate. It, after all, was FDA approved. I had hoped that Shasta would not use a flawed design. They unfortunately did. KB and all of his industry friends knew this and convinced him in 2009 not to get involved. My company would have passed too.
Shasta and Knickerbocker used the J&J predicate to design the first generation Genstrip in 2009. It did not work and were set to receive an NSE (Not Substantially Equivalent) letter from the FDA. So instead they withdrew their application. Just between us friends here, I think KB could have pounded out the 510k even with the product flaws. KB does something brilliant when he takes over a 510K prosecution. He employs a guy from the industry who writes allegories. A few allegories and some whip-smart answers to the FDA AI (Additional Information) letters could have gotten a mid-2010 approval. But that's another story.
In 2010 DECN got involved as the distributor, only the distributor, but because of Shasta's incompetence in 2009 and 2010, they put penalty clauses in their contract with Shasta. When in December 2010 Shasta had still not filed for a new 510k application, DECN called their penalty. At that point Shasta owed to DECN about $2.5 million in penalties. So DECN and CTI, the contract manufacturer took over the project, re-engineered the Genstrip and got it to work and also marched it through a very tough FDA process with FDA all over their backs. KB would share the AI responses with me, full of allegories. They were convincing for upper FDA management."
I've never seen DECN clawback one dime from Shasta. So will this ever happen? What kind of assets can be attacked? Or is this a dry well,leaving no ability to recover any funds?
All I know Shasta submitted their 510K for Genstrip in December,2010. It was predicated on the 2134 One Touch Ultra system(2001) and was approved in 2012.
How Unistrip can get the same 510K designation as Genstrip but use the 1992 One Touch strip predicate(K923544) brings into question
what tweak was necessary to bring equivalency. This K923544
is the same predicate Incline used to get it's IP approved for the earlier One Touch meter line(92 - 2000). So one could surmise the same tweaking of the "borrowed technology" onto the 3544 platform
brings the OneTouch strip up to the One Touch Ultra design.
So this guy you are sorry you ever heard of beat the FDA bias and got a 510k but all he still wanted to be was a distributor and manager of the FDA regulatory process which Shasta could not do. And all of this could have worked anyway if Shasta had done one simple thing, set up a QSR. That QSR is what FDA regulatory compliance is all about. That's what they inspect when they inspect your facility. Shasta didn't have one, in fact they didn't ever start one. That goes against about 8 federal laws."
One good thing/accomplishment doesn't clean the slate on a myriad of others.
SO didn't KB insist on seeing this QSR before he signed his distribution agreements? Wasn't he monitoring all this,especially with his familiarity with the importance of some of this stuff? Even up to 2013...when Cal was still conducting business out of the garage?
So the guy you are sorry you ever heard of, then went to Shasta and bought the 510K."
Which is the IP in essence. Unless what your saying the IP is still only being licensed from Shasta? That DECN has not purchased this IP outright,only the 510?. Has this been established?
Do you want to clarify this?
Two weeks later the FDA gave Shasta the death penalty and damaged all DECN shareholders further. Good thing KB had some foresight, bought the product, established a QSR, and passed inspections. Then, but I am getting ahead of myself, he made a deal with the Koreans and redeveloped the product within FDA guidelines to drive around J&J's then still alive '105 patent. I just don't know where he would find the extra time to be the criminal schemer and incompetent you accuse him to be.
Well,why a work around of the "105"? This was on it's way to being defeated,right?. As for scheming and seemingly poor Business execution,each of these actions we examine here stand on their own. They either cut the mustard or they don't. Look,I would prefer there was nothing to talk about here.
scoop the entire industry knows this story as do virtually all of the long shareholders. DECN will never pay that $2 million. And they sued Shasta in California Superior Court to get the $14 million in damages that they are owed.
Is that litigation still on going? Does Cal have $14 million? Or is this,Shasta litigation, a waste of time?
I told you the Shasta story, but the predicate device stuff and all of your other negative conclusions are just wrong factually. If you are that interested, take some time and learn this stuff.
I'll need specifics for you to make blanket statements. Otherwise,I've shared Accurate information. I've been speaking about this stuff for awhile, And if I've made a mistake,please share it with me. I have no problem correcting the record. If anything,I've made specific replies to your inaccuracies.
And by the way, domain names cost $10 a year, $35 for three years. Are you taking Mr. Lyons to task over an alleged $10 conflict that helps you as a shareholder?
Devil is always in the details. A disciplined firm committed to accurate information doesn't make sloppy mistakes like this. Diabetic testing is such a precise endeavor,yet it amazes me that so many examples of this type of disregard for "doing it right" occurs. Again,why not simply then put it under Decision Diagnostics?
Unless there was a reason for it. A $10 registration of a website under one company's name can turn into who knows what kind of dollars for "web site managing fees" for another. It's not the $10... Like I said,so seemingly innocuous,but so ripe for inappropriateness.
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