Dirk, I assume you mean products for humans?
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Posted On: 08/11/2018 3:50:33 PM
Re: DirkEaston #5419
Dirk,
I assume you mean products for humans?
I understand that DECN is going to do two clinical trials in 2018. The first, GenChoice is currently in clinical trial. As soon as that trial is complete and the independent IRB (expert) report is issued, GenChoice can be made immediately ready for certain international markets. And no matter what you may read on the iHub board, almost all of the new products brought to market by U.S. based companies are first sold in international settings so as not to allow the FDA to play politics -- although these days DECN is on the right side of the FDA politics.
Figure late September to mid-October 2018 for GenChoice. About a month later the application for 510K will be filed with the FDA. Figure 6-9 months for clearance. I have seen some of the test data, shown to me by the company's retained outside technical expert, and it is outstanding, the best I have ever seen for a GDH based product. Unfortunately that is meaningless because everyone the only thing that matters is stock price and since the sotck price is down everything associated with DECN stinks, is criminal, is a lie or worse.
GenPrecis is very interesting. No matter what you read from the angry and the pretenders on the iHub board, test strip products still account for 99+% of the revenues in the worldwide diabetes testing world. GenPrecis is a radical departure. GenPrecis has hospital analyzer precision and accuracy in a handheld device. The product, even in its almost finished form, laughs at FDA guidance regulations. It is going to be a big success because it has a very different but very positive value proposition.
GenPrecis is a late 4Q product. DECN may decide not to run its clinicals in Korea for GenPrecis. They may want the positive publicity by running the clinicals in what the politicians call "fly over country."
I assume you mean products for humans?
I understand that DECN is going to do two clinical trials in 2018. The first, GenChoice is currently in clinical trial. As soon as that trial is complete and the independent IRB (expert) report is issued, GenChoice can be made immediately ready for certain international markets. And no matter what you may read on the iHub board, almost all of the new products brought to market by U.S. based companies are first sold in international settings so as not to allow the FDA to play politics -- although these days DECN is on the right side of the FDA politics.
Figure late September to mid-October 2018 for GenChoice. About a month later the application for 510K will be filed with the FDA. Figure 6-9 months for clearance. I have seen some of the test data, shown to me by the company's retained outside technical expert, and it is outstanding, the best I have ever seen for a GDH based product. Unfortunately that is meaningless because everyone the only thing that matters is stock price and since the sotck price is down everything associated with DECN stinks, is criminal, is a lie or worse.
GenPrecis is very interesting. No matter what you read from the angry and the pretenders on the iHub board, test strip products still account for 99+% of the revenues in the worldwide diabetes testing world. GenPrecis is a radical departure. GenPrecis has hospital analyzer precision and accuracy in a handheld device. The product, even in its almost finished form, laughs at FDA guidance regulations. It is going to be a big success because it has a very different but very positive value proposition.
GenPrecis is a late 4Q product. DECN may decide not to run its clinicals in Korea for GenPrecis. They may want the positive publicity by running the clinicals in what the politicians call "fly over country."
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