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Advanced Medical Isotope Corporation Message Board

  • zippy_icon zippy_icon Oct 20, 2013 9:55 PM Flag

    RadioGel application

    Does anyone know about the status of the RadioGel resubmission? Last time in the CC, they mentioned about filing the medical device application in the next 60 days ... Like to hear from the company.

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    • moto1960@sbcglobal.net moto1960 Oct 21, 2013 8:38 PM Flag

      Yeah Zippy, according to the smallcapvoice interview, which was exactly 2 months ago, AMIC was suppose to file a 510(k) application within 60 days. Since the 60 days are up as of today, it would be safe to assume the 510(k) filing has been done. So if you tack on 90 days from today, that would put us at mid January. As I alluded to before, these things don't always go as planned, but ideally we should hear back from the FDA in the next 3 months. The 8K also mentions the caveat of funding, so we'll just have to wait and see. My expectation, and the 8K states, first qtr. of 2014. We probably won't get an individual statement on the 510(k) filing as a P.R., so #$%$ stated, best to call the company or wait for the 10Q next month. MDLAND~

    • Guys, I thought that it already had been sent in September. Then 90 Days for response from FDA. Need to check directly with the company.

      SS

      Sentiment: Strong Buy

    • moto1960@sbcglobal.net moto1960 Oct 21, 2013 1:27 AM Flag

      Resubmission or 510(k) filing? Good question either way. The 8K states under, " Why invest now?'', FDA form 510(k) for Y-90 RadioGel to be filed soon. FDA clearance anticipated first quarter of 2014.' But, as you and I know, these things don't always go as planned. I guess the first question, if you use the 8K as a reference, would be, when was the draft for the 8K written? Either way, it looks like we're a few months out. An update would be great, but we might not get much news, if any, before the 10Q, which is scheduled for mid November. MDLAND~

 
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