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KMBSOUTH

11/20/17 12:21 PM

#764 RE: usma1992 #763

I will try to answer what I know.
US FDA should not take 2 years for a yes or no according to the 8k. They said they were going to do a 9 month study that should meet all the standards that the FDA said was still not meeting to be approved and so I would say mid year 2018 we should hear on this.
I agree with you on ASIA I would think within 3 months we get some sort of answer also SMI contract should be up within those months and they either have to order 1000+ machines or rewrite the contract.
India I can't speak on that.
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carbonfiltered

11/20/17 12:53 PM

#769 RE: usma1992 #763

India is coming soon, they will update us before end of month regarding them in my opinion. I believe the Chinese FDA update will be included in that as well. Right now I believe they’re trying to raise financing for the study which will probably cost a couple million dollars. And this is the bottom, I believe the outstanding shares is just over 20 million. One thing I can tell you is that gene Cartwright hasn’t taking a salary in two years, so I know the financing isn’t to pay the CEOs and higher ups. It’s very clear they are not diluting or at least trying to not over dilute the share pool. I didn’t think they would release a PR during a holiday week so I expect a PR next week for sure and they will update us on all the new developments including India which would be massive. What I also know is the FDA has reduced its requirements for approval of this particular type of device, the data that we do have from the first studies is sufficient for approval I think it’s somewhere around 40% efficacy but I can guarantee you the FDA wants new data which is why we need to build up financing.