Decision Diagnostics Corp (DECN)

[IPwatcher]

the FDA won't accept the clinical trial data and the company has to go through US clinical trials according to FDA.

The distinction between 'Clinical Trials' and 'Device testing' is very important here.
The FDA PREFERS clinical trial data to come from the population in which the treatment is to be deployed.

Clinical trials determine the safety and efficacy of a new treatment. And the FDA want to know for instance that a treatment which was safely administered to lithe Japanese subjects with a BMI of 22 will not be harmful when dosed out to corpulent Americans with a BMI of 28. Which is why they prefer US trial data. They will accept trial data from anywhere so long as it satisfactorily answers the question "How will this treatment play out on my US population?" The easiest way to do this, of course, is to do the trials ON the US population.

Diagnostics Device testing is different. Device testing is NOT a clinical trial. It is a validation/ verification activity.
The damn thing either works or it doesn't.
The FDA want evidence that the device is safe and effective. They don't care where geographically that data came from, as long as it is robust, validated and verifiable i.e. produced to the right scientific standard.

Its A bullshit excuse. Berman does not have Korean data that would satisfy the FDA, if it had been done in a US lab. If he did, he'd submit it.

If he HAS any data, its not the fact that it is Korean that would trouble the FDA. Its the fact that it wouldn't satisfactorily address the required claims.

Don't take my word for it. Go look on the FDA website. Its full of 510K submissions and device testing from international labs being used to clear diagnostics devices into US markets. Heave a brick, hit a dozen.