You said it, it’s 6 month process. We are 6 months after that.
I never said that a generic test strip would take 6 months. That was said on the other message board and migrated over here. There have been only two "generic" strips approved under the new FDA review team which took over in 2009. One was DECN's Genstrip and it took 23 months and 29 days. The other "generic" test strip took 23 months and 18 days. DECN's strip has done pretty well for itself, the other test strip has been a disaster for itself and the public. Subtracting out the government shutdown when nothing was reviewed by the FDA or even acknowledged, Genchoice has been in front of the FDA for 9 months. It will be approved, probably not soon enough for a NOBO like yourself because the approval won't happen on a Saturday or a Sunday, or the week before Thanksgiving. And one more thing, lack of company attention is not the cause of the delay. DECN employs the premier FDA Administrative law firm for in-vitro diagnostics. You work with a government regulatory agency, you hire the best lawyer you can afford, and take his advice totally. Not good enough or fast enough for the NOBOs, then too bad. that is just more proof that know it everything NOBOs should not be guiding or running a company.
A company in this business should also employ the best in-vitro consultant possible who can get into the sewers with FDA's comically unprepared staff and beat them with the science -- which is their real job, science not politics.
But here's a news flash. My recommendation to KB was, get the approval (it is actually called a clearance) and then immediately follow up with a TGB version of the same test strip without ever selling the "generic" version. Do something unique that would have much, much more value as a competitor. Abbott, which has its attention glued to its continuous glucose monitor would welcome a curve tweek for its 10 year old Freestyle without having to go through redevelopment cost. But you know what, doing that plan would not reflect the current share price is everything mindset and would cost the company some money.
I never said that a generic test strip would take 6 months. That was said on the other message board and migrated over here. There have been only two "generic" strips approved under the new FDA review team which took over in 2009. One was DECN's Genstrip and it took 23 months and 29 days. The other "generic" test strip took 23 months and 18 days. DECN's strip has done pretty well for itself, the other test strip has been a disaster for itself and the public. Subtracting out the government shutdown when nothing was reviewed by the FDA or even acknowledged, Genchoice has been in front of the FDA for 9 months. It will be approved, probably not soon enough for a NOBO like yourself because the approval won't happen on a Saturday or a Sunday, or the week before Thanksgiving. And one more thing, lack of company attention is not the cause of the delay. DECN employs the premier FDA Administrative law firm for in-vitro diagnostics. You work with a government regulatory agency, you hire the best lawyer you can afford, and take his advice totally. Not good enough or fast enough for the NOBOs, then too bad. that is just more proof that know it everything NOBOs should not be guiding or running a company.
A company in this business should also employ the best in-vitro consultant possible who can get into the sewers with FDA's comically unprepared staff and beat them with the science -- which is their real job, science not politics.
But here's a news flash. My recommendation to KB was, get the approval (it is actually called a clearance) and then immediately follow up with a TGB version of the same test strip without ever selling the "generic" version. Do something unique that would have much, much more value as a competitor. Abbott, which has its attention glued to its continuous glucose monitor would welcome a curve tweek for its 10 year old Freestyle without having to go through redevelopment cost. But you know what, doing that plan would not reflect the current share price is everything mindset and would cost the company some money.
