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Re: jimtash post# 18875

Thursday, 11/21/2013 9:04:12 AM

Thursday, November 21, 2013 9:04:12 AM

Post# of 30046
You ask some good questions, jimtash.

The GCDx rollout is "behind" because GCDx doesn't have a license agreement with Radient. Even if they did, the main problem with GCDx is FDA regulation.

The 23andMe story is an important story for anyone thinking Gartner can sell onko-sure on the internet without FDA clearance:

http://www.nytimes.com/2010/06/12/health/12genome.html?_r=0

That was from 2010. 23andMe is STILL trying to get FDA clearance. Read the Letter to 23andMe on the front page of the FDA device site (near the bottom of the NEWS section):

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitrODiagnOstics/default.htm

23andMe is backed by big money (Google) and was in place before the FDA caught them, so they were allowed to continue selling the DNA tests on a limited basis, but the FDA is not going to allow little GCDX to sell DR-70 while they go through the 510(k) process.

And Gartner faces an imposing obstacle: he wants to sell DR-70 as a SCREENER, and the FDA is never going to clear DR-70 as a screener.

That makes GCDx a poor business plan, and is probably the reason Gartner has had trouble getting funding. He thought he had funding in 2012 from one "Midwestern investor" (see the 8-K) but that investor bailed out. Since then, Gartner tried pitching his plan at AZBio in the spring and then tried Fundable in the summer. If he had funding, he would not have tried either of those seemingly desperate attempts to get money. I am surprised they allowed a sales pitch like that at AZ Bio -- it seems to cheapen the event.

Regarding a takeover group remaining hidden -- there is no takeover group. That was just a message-board rumor created in 2011 when the company's finances and outlook seemed brighter.

Regarding the patent -- how will the new patent "secure revenues?" Do you think customers are waiting for the patent to be approved before they buy? I think that patent is far under the radar of everyone except RXPC shareholders.

That patent is being reviewed by the same examiner who rejected it the first time. I think that examiner is not excited about reviewing DR-70 again. Small-Howard re-submitted the application on the last day possible -- it does not look like a priority for her either.

In summary: GCDx is a business plan doomed to fail, there is no takeover group, and the patent is not a high priority for anyone other than RXPC shareholders.
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