right now. Okay. All suitable. So I have experienced you for a lengthy time for a longer time than I promised. I've a single question. Then I will check with you, if there's everything we haven't mentioned, a number of individuals requested me, islet how like, you understand, 40 carbs of I do not know, a tender pretzel, and 40 carbs of cotton sweet, 40 and forty. But significantly different impacts, it doesn't make any difference towards the
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do Imagine yes, it is possible to. You should buy you can buy. We've got considered one of our distributors that means that you can buy immediate for those who have been to do a cash shell out. All right. So yeah, I do think it's very, very similar to the worth you may buy an insolent a tough insulin pump. So, you understand, a number of $one,000 is what you'd assume to pay for from pocket cash shell out. And you'd probably obtain that not directly from beta, but considered one of our, like 8 or 10 distributors that we're working with.
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And so the FDA suggested that we use that since the predicate system. And we went ahead with that, that submission with that in your mind.
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Yeah, so It is really an excellent question. So we had been really thorough not to obtain an higher limit on HBO and find out, and that's unparalleled. You will find hardly ever been an AI D study, where where there wasn't a Restrict on upper limit on HBO and see a pivotal trial. So we, you are aware of, for for the market application for a device. And so we had been really apparent concerning this, we wanted to make certain that no more than a fifth, we questioned the sites to Restrict those, those people that you randomize these types of that the limit Restrict or fill certain buckets, so ensure that that not less than a third of them Have got a just one C previously mentioned eight%. And no more than a fifth have an A 1 C beneath 7. And that's mainly because these significant epidemiological studies on the market such as the T Wendy exchange, and various studies have demonstrated that on commonly within the US, these studies are likely to corroborate that only about a single in five men and women satisfy the American diabetic issues Association target for therapy.
So So for clarity like, I am unable to use islet and realize a five 5 a a person C with there is not any way for me to control it or do that sort of stuff without copyright's.
know for certain I've another question about that. Then we can undoubtedly move on. Am I Incorrect? Just say that within the very, incredibly beginning. You think about this going on with a tandem pump?