Someone spent some bucks to get that patent granted. If you examine its transaction history it had two final rejections before being granted (if you don't know what final rejection means and how you continue pursuing it after that do your own DD and don't ask me to explain). I believe each refiling requires more fees and work to do whatever they found lacking in the previous filing. BTW, if anyone had been tracking this they would seen that it was approved in July (I sure wasn't it didn't enter my head that they didn't have all the patents they wanted already approved) but not officially mailed out until early sept. The inventor is Dr Fisher with this being his third related to the radio gel technology. I didn't find any more patent submissions under review in his name. This looks like the last one related to protecting their inventions. It still has to get approved by the FDA. Sensi you seem to have not believed Jim K's comment in his radio interview in mid-Aug that they would be 'talking' with the FDA for at least another month and maybe two. Meaning they won't even think about refiling until mid-Sept. Now add him always underestimating how long things take and push that to Oct. Then give them a month to refile and we are in Nov before they refile. However, after talking with FDA for two months they may learn it is pointless to refile as clinical trials will be required. If that happens we have a long, painful, dilutive wait on our hands.
The PR says they had to do an unplanned pilot study to figure out what was going on with the unexpected results of 202 in the ongoing study. It looked good and now they are going to repeat the bioequivalent study (probably to get good results on the Cmax). My guess on the extra dilution is that Nasrat hadn't gotten the results back when he said no dilution, but when he did he knew he had to address it and ASAP to make sure he had the good results he wanted going into the Oct. meeting. The dilution probably covers the cost of the pilot study and the extra study starting in early Oct.
Hurray!! They sold the last of their shares on Aug 27. I hadn't kept up.
A reference to one conference was already made just a few posts ago (Rodman and Renshaw). You say they are presenting at more than one conference... what are the others? They present on Weds not Monday. Most companies like to go into these with fresh news...we will see. The last conference they attended they put out the P.R about the 1 million truck and generator order. That news did nothing for the share price, it kept dropping because of spirit bears dilution. Spirit bear still has over a hundred thousand shares on had to dilute, but if the news it big enough (when will they sign a license agreement with ESSCO already!).
A couple of quotes
"We are now answering questions from FDA and expect to be answering question for the next month or two"
"We have been approached by several multi-billion dollar companies to either partner with strategic partner with or greater and we have to date not been willing to sign any issues as to what that would like and the primary thought process we have been doing this so long, we believe we understand what we have, we believe from the physicians and radiologists we have talked to around the world what we have, and that once we are able to get final approval from the fda its worth that much more. So as much pain as the market place may be, we believe we will be fully rewarded and our stake holders will be fully rewarded in due course.
Get comfortable, there is going to be a bit of a wait, but good news on the interest from partners.
Psst, shekels don't talk to the crazy people....ronrunoff and buzzy (probably one and the same) might lose steam if he/she doesn't get attention (it seems a bit high strung, irrational, and emotional for a male). Otherwise why reach out to us in their posts. I have them on ignore so I usually see nothing, but I admit I find them so weird and crazy they are interesting in a car wreck sort of way and every now and then I open a few of their messages, but I always immediately regret it.
BTW, if you ever have the follow up call please share. My hope is that the 30 days estimate for refiling was true, and that the in person meeting with FDA had already occurred. One would think that if a trial was necessary they would of said something then. While Cadwell has plenty of money if all were lost I don't think he would throw away 20+ grande once a month on more shares.
I did just scan it, so I could be wrong. I am pretty sure the older draft had two flow charts one for starting from de novo another for transitioning from a 510(k) process, with the time frame for the one from 510(k) being shorter. What I found was a draft, and by definition is not final, nor was it on the official FDA website, so it could of been incomplete, but it read more like they decided to keep one de novo process flow for whether you it was being started after a 510(k) or pre-sub. The good news is that according to ADMD recent filing they are going through the pre-sub process. As this is not required but "allows FDA to provide feebback on whether the device is suitable for de novo process and/or to advice on the documentation need in a subsequent de novo". So if they submit it means the FDA said they had a shot at de novo approval.
Thanks for sharing the content of your call. Given the wackos that are apparently harassing them, they may never answer their phones again, but if you manage to talk with them again hopefully you will share that also.
Off topic, but the recent volume set off the chattering of the TA investors so I think some of the recent purchases may have been to investors who follow technical analysis. If a PR indicating submission is not made soon, the technicals will fall and they will dump their shares.
A new draft of the de nuvo process was published by the FDA a couple of days ago. In a quick glance it looked like there is a 120 day time period between submission and notification (not the 60 days the poster who claimed to have talked to Katzoff said), and that was best case if the FDA didn't require additional information during the process. So even in the best possible scenario (they submit and get approved as de nuvo) it looks like more dilution for the Dec warrants may be unavoidable. If they want to save shares from more dilution they need to resubmit ASAP.
If I held warrants that came due in June and July and I knew (which I would) that several other warrant holders were lined up to liquidate after me I would definitely sell my shares as soon as I could. Then I would wait for After the last date for warrant conversion (Aug 10 ..I think) to buy back in. For the conversions that took place in late June the price would of been about 0.02. My warrants would of converted around at 0.012. That 2 cent price held well into July so I would of made a 40% profit on top of interest. Now with the price near 0.0005 I would probably toss a bit of my profit back.
Bottom line the warrant holders probably know more than we do, and they probably have a nice bit of profit. So I think a good portion of the buyers are the warrant holders.
I also think sitting on the PR for the Battelle debt conversion was a strategic move to try to combat the price drop associated with the dilution. I think the people who loaned ADMD the money are probably friends and business associates of Cadwell so he is not going to let them lose money.
I do not think they can survive the expiration of the most recent loans unless they get FDA approval before Dec. The conversions for the previous loans probably took more shares then they imaged because of the price drop and they may not have enough shares left to pay off the loans that will come due in Dec. On the other hand, if they resubmit and get more input then they will probably know exactly why they need to do to get approval and can look at options of partnering with someone.
You don't have any loss unless you sell and you don't have a total loss unless they declare bankruptcy which could take years if they do what you claim they will. If they do declare bankruptcy it's a pain and takes extra paper work to write it off because you have to prove they went bk. you can still sue if you sell but you also get tangible documentation of your loss. Selling now also allows you to offset profits in other stocks. Any civil suit will be years after they go bk which may be years away.
so please please sell!!!!
As I clearly stated the example was one from the future, and that the ones that I believe have converted were loans made in the past. Below is the note that i think has the last conversion date until Dec. So while the loan is 'due' in Feb 2015 the investor could of instead choose to convert the debt plus interest into shares after Aug 10, 2014. My bet is that they did that and then turned around and started liquidating those shares to get their money back. The only way they would lose money if is the value of the stock decreased a lot more than 42% before they could sell, and if they had to sell most of the shares for under that 42% profit. If I'm right then it means that these investors decided that cash now is worth more than the companies stock and that they didn't want to wait until Feb 2014 to get repaid. If they thought the stock would go up I don't think we should see the dumping of shares we are seeing now (meaning they would take their shares and sit on them waiting for the price to increase). It looks to me like they are trying to get their money back plus a bit of a profit.
I'm not at all saying this is a good thing. What i found interesting is that the company managed to continue to several get more of these loans through the end of July.
(6) The Company borrowed $50,000 February 2014, due February 2015. The holder of the note has the right, after the first one hundred eighty days of the note (August 10, 2014), to convert the note and accrued interest into common stock at a price per share equal to the lesser of $0.07 or 58% of the lowest trade price in the 10 trading days previous to the conversion.
To correct your statement for others below is a cut and paste from a loan coming due later in the year. It, like the ones that came due recently allow the borrower to convert at 60% of the current stock price. I have no clue where the 0.046 you quote is coming but the filing clearly indicates the loans I refer to and their conversion price. Come Dec 23 if the price is $1.00 they will convert at 0.60 cents.
20) The Company borrowed $40,000 June 2014, due June 2015. The holder of the note has the right, after the first one hundred eighty days of the note (December 23, 2014), to convert the note and accrued interest into common stock at a price per share equal to 60% of the lowest trade price in the 25 trading days previous to the conversion. The Company has the right to prepay the note and accured interest during the first one hundred eighty days following the date of the note. During that time the amount of any repayment is 145% of the outstanding amounts owed. The Company recorded a debt discount of $40,000 related to the conversion feature of the note, along with a derivative liability at inception. Interest expense for the amortization of the debt discounts is calculated on a straight-line basis over the twelve month life of the note. During the six months ending June 30, 2014, total amortization was recorded in the amount of $438 resulting in a debt discount of $39,562 at June 30, 2014. Also during the six months ending June 30, 2014, interest expense of $44 was recorded for the note.
Between Jan and June ADMD borrowed money and handed out a bunch of convertible notes in exchange for the money. About 70 million of shares were distributed for those converted before the end of last quarter. In most cases investors were given the stock at a 40% discount to the current price. So if they could sell that stock before the price dropped 40% they made money off the loan. A ton more of the loans came due between July and mid-Aug. I think that explains our dilution we are experiencing at the moment.
The interesting thing is that through the month of July they acquired more of these loans (~$200,00) and even paid for consulting services with stock. These new loans can be converted in about 6 months.
Given all these promisary notes were in the last filing we should not of been surprised by the recent dilution. The writing was on the wall as the obligations of the loans had to be met. It also means a good part of the dilution is for these note (otherwise why would they continue to borrow money in exchange for notes rather than dump stock through July.). I am sure they are hoping that by Dec the price will be higher so the amount of stock exchanged will be smaller.
So through the end of July they have continued to borrow money and even convince someone to take stock rather than money for consulting services (whomever it was that did the consulting could of just said no to the work rather than work for stock). Also it looks like the last conversion date has already passed. So hopefully the dilution will stop soon (not saying that the stock will drop in price, the sub penny value is freaking people out).
If the FDA wants trials I don't see how the company can survive. It looks pretty ugly right now, but I must admit I am confused by their ability to continue to raise funds. They must have a pretty good story to tell someone...wish they would tell us it too.
Maybe it the soapbox lady hadn't wasted our time someone would of asked about the dilution. I don't believe nasarat would of dodged the issue if asked and he said he trusted us to ask what needed to be asked so he chucked his presentation. I think what changed between the two calls is he made the decision to go it alone on the first ART and therefore needed more cash on hand. But I don't have a better place for my money now, if I did I wid also sell some. I hate typing on my phone!!!! Good luck!
The details of the human abuse testing were interesting as was the isradapine launch in last quarter of FY14. Also news that they have continued talks with both companies mentioned in the last CC since the last CC, that the manufacturing space can meeting 2 or 3 ART product needs, and that they have been asked for and received proposals for marketing Eli-200 and at the same time are talking with large pharmaceuticals about doing the market in a profit share mode. Also new is that he doesn't expect to go to bigger exchange until after one or two abuse deterrent products are on the market and generating revenue. The last bit of news was helpful was that Nasrat set the schedule for ongoing studies to conclude before his meeting with the FDA in Oct, not the upcoming R&R conference and that he doesn't expect results before the conference. He continues to show that he is motivated not be near-term stock price not the short term. My guess is we stay flat until just before or after his meeting with the FDA in Oct. Thats fine with me, I'm here based on the belief the company will be one of the few that move out of the OTC land not by going bankrupt but being successful.
I don't think Nasat is interested in marketing the stock yet, he is busy working. I think the big news will start a few days before the R&R conference. He will not want to minimize any lulls in the interest from the R&R, then the meeting with FDA, and lastly submission to FDA. I think he is waiting until he can see the 'whites of the investors eyes' before firing off news. Many investors here are turning tail and running before that. I know people have said he can't hold back news, but he can set expected deadlines with companies (excluding FDA of course) that coincide with when he wants to know/achieve something. My bet is he requested to hear news on the bioequavlencies and human abuse studies no later than as such he will hear maybe a day or two before that date, but likely on that date. I say that because despite what Dianne said big news tends to have been near times he was going to present or CCs. He can't control when FDA approves generics so those PRs can come at any time. I think your a little too optimistic for the near-term. The 10Q will not cause anyone to invest who isn't already, but it was bland enough that we could lose short-term investors.
I have worked with NASA engineers... typically they are engineers to the bone, meaning its all about the cool technology (talk about an unreliable job, you don't work for NASA unless its for a love of technology because you never know when you will get fired. You also have to wait a decade or more to see the results of your efforts..if ever). They are doing the right thing to bring on board business and technical savy advisors, because I'm not sure they are very good at marketing. Their presentations (they have made about 3 since may) do not generate any interest in the stock (if anything the price drops after one). I think because the audience has to understand the technology/physics to some extent to really understand that it is not a pie-in-the-sky implementation (i.e. it probably works as they say it does) and that it is a substantial improvement over existing technologies. Because of this I think only revenue will move the stock or a collaboration with a industrial partner. What mystifies me is why one of the large engineering firms hasn't offered to buy them out or partner with them. Those guys do not need to see the green to believe they can look at the demo equipment and know. If they would provide CC calls we could ask. It would make me feel better, and probably attract more investors if they started having quarterly calls with investors like large companies do.
The other information that is relevant is "The Company has obtained input from the FDA regarding its alternatives and will seek further input to expedite the process. In addition, the Company is discussing with the FDA if additional trials will be necessary prior to marketing the device. "
I believe this confirms they have been talking and meeting with the FDA. The last sentence seems to confirm what Jim told shekels that there is a back and forth type of negotiation between the FDA scientists and ADMD scientists.
I found this sentence very significant...."Should the Company first receive regulatory approval outside of the United States, the Company could commence operations in the applicable territories.". That means they have decided to pursue approve outside of U.S. I also think that is why they are diluting. From looking at other medical device approvals outside the U.S. $2 million could get them there (i.e. 153 million shares at 0.013). This possibility may be their only chance. I think they are slowly (to minimize impact on stock price) letting shares out to get what they need to pursue non-US approval hoping that sometime while they are doing this they actually make progress with the F.D.A.