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Advanced Medical Isotope Corporation Message Board

  • shekels_galore shekels_galore Aug 12, 2014 3:21 PM Flag

    Conversation with Mr. Katzaroff

    I spoke with Mr. Katzaroff today at 2:00 CST. It was a very good conversation, and he was forthcoming in his answers to my questions. Below is the summary:

    I asked him about the FDA status. He mentioned that they are within 30 days of refiling under the De Novo classification. When the filing is made, he expects a 60 day timeframe maximum for a response from the FDA.

    I asked about updates. He pointed out that he does not want to put updates about things in progress, but only things which are definitive. When the filing is complete, ADMD will post an update.

    I asked him about the time that has went on since the last update. He told me the frustration lies with the education needed to demonstrate to the FDA how the product works including more data, particularly 3 things:

    1) That RadioGel goes directly to the affected site, and does not "leak" out to other areas

    2) How one applies RadioGel

    3) That it can be controlled and does not go all over the place like a standard chemo treatment.

    When I asked what next steps are if the FDA approves this, he mentioned that ADMD has been turning down partners and offers now as he believes the value of RadioGel is thousands of times more than what the current stock price shows. He told me his biggest frustration is the stock price right now, and he expressed frustration with the FDA process. I asked him with FDA approval, would they consider partnering or buyouts, he said he would consider, given that the price was right. The reason why he is not considering any offers now is that the stock price is horrible and the true value of RadioGel is in his words, "thousands of times larger" than what we see today.

    I also asked him about GreenLeaf. He did confirm that they are working with Heather Rosencrans of GreenLeaf and they have been instrumental in the refiling and helping to educate the FDA.

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