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Advanced Medical Isotope Corporation Message Board

  • kayak_wench kayak_wench Apr 23, 2014 1:19 PM Flag

    If it really has been rsubmitted as De Novo Classification we have a timeline

    If the poster who said that is what is going on is right they will have an answer by May 21. But if they went that route they did not tell us about the new submission. Which I believe is possible....

    From "Draft Guidance for Industry and Food .....De Novo Classification Process" FDA website.
    "A novel type of device may be eligible for the de novo process if it has received an NSE determination as a result of a 510(k) submission. In this case, in accordance with section 513(f)(2), the submitter of a 510(k) may, within thirty (30) days of receipt of an NSE determination for that 510(k), submit 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. The de novo petition must include a description of the device and detailed information and reasons for any recommended classification. FDA must make a classification determination for the device that is the subject of the petition by written order within sixty (60) days of the request.
    If we grant the de novo petition, the device is reclassified from class III into class I or class II. The device may then be marketed immediately and serve as a predicate device. Thereafter, we will also publish a notice in the Federal Register announcing the classification, the accompanying regulation, and the controls necessary to provide reasonable assurance of safety and effectiveness. If the petition is denied, the device remains in class III and may not be marketed."

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    • Kayak what do you think the stock would do the morning of the news release that the stock was class II and the company could proceed? I wonder how many shares would be traded with the strong handed shareholders that have stuck with the company and had been accumulating at these prices. What sort of price would shake loose some shares?

      SS

    • Kayak thanks for the clarity on the new filing if ADMD has indeed made it!

      This is very good news. At least to everyone but Team Ignore. You know they sure are down on this as well as insider ownership and the top dog's continued financial investment in the company.

      I guess this really does demonstrate that they do indeed hold NO financial interest in ADMD and do literally waste valuable time on this MB. Oh well, to each his own. I will just laugh harder when I see a greyed out TI name responding.

      Great conversations here the last several days. Love it.

      Good luck all, except TI, who have or are starting a position in ADMD!

      SS

    • Comical responses from the naysayers, shows they are only here for fun. Maybe we get a PR soon, been quiet for some time now. It could be a long process/journey to approval, but the risk is worth the reward.

    • If it was resubmitted word would get out and this would not be at near nothing volume and struggling to hold 3 cents. Nice try though. Good to see some new BS being posted. The old stuff was getting very lame.

    • That was me. Yes, it is true. Take a seat and enjoy the show. :) I've been loading up at these crazy prices.

      Sentiment: Strong Buy

      • 3 Replies to jhu_bluejays
      • That is a positive bit of info to end the day on

        Thanks Jhu.

        I am loaded up and averaged at .06. If this stock stays put I will bring that average down further!

      • Are you the same Bluejay that said big news was coming on April 16th? If ifs and buts were candy and nuts every day would be Christmas.

      • Thank you for sharing. I hope you don't have insider information, but you don't need to to have come to this conclusion. You just needed to know about the option to submit as De Novo (which even the FDA says not enough people are). Its a safe bet they are going this way....or should be kicked in the butt if they are not. Interestingly if they are, and didn't put out a PR, if it is denied they don't have to provide an update. May 21 is probably early as the 30 days and then 60 is likely business days. If we don't hear anything by June 1, I think that will be a bad sign. Thanks for giving me an optimistic May!!

 
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