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Advanced Medical Isotope Corporation Message Board

  • kayak_wench kayak_wench May 15, 2014 4:47 PM Flag

    from 10K looks like they did not submit de novo

    They indicate they are still evaluating there options and trying to figure out if trials are an option. I think if they had submitted a de novo petition requesting FDA to make a risk-based classification determination for the device under section 513(a)(1) of the FD&C Act they would of legally had to say that in the 10-Q. I would love to know why they didn't at it seemed a good fit. But I don't see them answering that. They did manage to trade shares for consulting services in Feb. and Mar. which means they convinced someone they had a chance. But no consulting services since. So if they are weighing their options I'm not sure how they are doing it. A flood of stock at a penny or hundreds of pennies a share is not going to go very far.
    But frankly I think the company is toast :(

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