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.
AMIC needs to come full throttle with this De Novo process, or else they'll get classified again as a class III. Of course, Class III is a much more detailed, time consuming and expensive process. AMIC needs to make sure that all of their ducks are in a row, because this could very well be their last shot. If we can get classified as a low to moderate risk device (Class II), there will be a much less difficult path to production and practice. In Shekels' post, he alluded to the fact that AMIC has been turning down partners and offers. While I'm sure there are a lot of companies out there that want to be a part of AMIC at a penny a share, but they aren't the ones selling shares, diluting their share price to raise funds to try and get this through the FDA.
While we don't expect anything this week or even this month, an 8K notifying us of the filing would be great. Again, all parties involved, from Jim, to Heather to PNNL need to come with all they've got because at this point it's a race to see which happens first, . . approval or depletion of cash (authorized shares) MDLAND~
Thanks for the update. You could have kept it to yourself but you shared and I appreciate that. Jim has always been great to speak with when I have called them. I would have liked to know when they are filing quarterly. With your post I am even more pleased to have added more shares .012.
I wonder why you got thumbs down? Your points must contradict Team Ignore's. No surprise though, what you did here is called due diligence and that is foreign to them.
Excellent DD, appreciate the effort and feed back. Like I've said all along, RadioGel is the Future of Brackytherpy and worth 100's of Million$.
It's not going to happen over night, but it will happen!
Ask him why he is dumping millions of shares on the market if he thinks they are worth thousands of times more? He's a con artist that tells you what you want to hear. Never any firm progress just more let me tell what I'm going to do hustle.