I see. So you are revising your numbers significantly upwards now. You are in a significant conflict with your post earlier this week conveniently at the top of this thread.
It appears you actually know very little about what this stock and company will indeed do. It can still go down I guess based on your posts but that is no different than flipping a coin and calling heads or tails.
Good luck guessing the action or value of this stock in the days, weeks and months to come. Maybe we will keep track to how often you are right or wrong. Would you like that? Team Ignore can do that for you. They are the only ones who keep track as they have no interest in what the stock does as they have no financial interest in the stock.
Good guessing and good day.
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!
That is a positive bit of info to end the day on
I am loaded up and averaged at .06. If this stock stays put I will bring that average down further!
Excellent. Not sure how you figured that one out. Not even sure exactly what that "De novo Class II" meens. I will do some more DD
I do not know but will check. Another place to look is in their quarterly SEC filings as usually companies update shareholders on all current studies. You can get a rough idea of when the studies launched and were completed. Studies and status are always top issues.
I would be completely shocked and very happy if RadioGel was determined Class III and ADMD did not have to do a study.
Class II, no idea...period.
Your question to me amounts to a guess in return. On FDA approvals I have observed pharmaceutical companies work through the process. It is likely far different for medical device companies. I am guessing the trial ADMD would have to do would amount to a phase 3 pharma trial with a minimum enrollment of 300 peoples. I think it would be a minimum 12 month trial, with 6 months to assemble the data to present to the FDA and then 6 months to clarify and approve.
My assumptions come through watching Imunex/Amgen, Imclone, Omerus, Acadia, Dendreon and Cell Thera work through it. Of course some phase 3 trials went longer and others a bit shorter. All Pharmas though, not device companies.
Class II, no one knows since the process of reclassification is not understood nor have timelines been shared with anyone but the company.
Class III, I would guess 18-24 months from the start of a study. It would depend a lot on the size of enrollment and what the study endpoints are, plus the time it would take to get a partner and financials squared away to do the study.
All a total guess and not much of a discussion to try to have here and now based on what anyone besides Jim K and the BOD know. Without any endpoint guidance from the FDA it is impossible to be any more accurate than a total guess. Sucks but true.
Kayak, it is fully absorbed and whether there is a biological affect is the question. FDA is safe puting a Class III. They are telling ADMD to prove that it does NOT have biological affect on humans in my opinion. Do the test and if it has no biological affect on humans then we will gladly change our Class III to Class II. There is no human data, even for something "else", like this to fall back on.
Now back to the EMA. Would this process have been a hinderence under their program? I brought it up last month. Could ADMD try to go for an Orphan status in which doctors may use it as a last option at their discression? I do not know if they have that for medical devices like they do for drugs. In this approach use is also "test". Revenues are generated but at a discount due to EMA repayment structure but at least ADMD is getting somewhere with this thing.
HEY! Communication is killing us today. I admit that is one of the biggest problems facing this company and you and I. The lack of communication with a world that needs to know should be corrected immediately and unfortunately I believe that starts with who works for the company and who doesn't anymore.
Zippy it must be Rule 7. With what we know it clearly qualifies as such with biological affect fully absorbed. What I really do not like here is that ADMD somehow got themselves to believe it could be Class IIb. I do not see it. Now correct me if I am wrong the 510K was submitted to the FDA for just this problem, to clear up the Class of filing. It sure looks cleared up now. Appealing an FDA decision is tough to impossible. It certainly does not happen every day and even appealing could require tests. I just don't see this going any other way than Class III. If I am wrong then great, I'll take beatings here for my belief it is Class III.
Two good questions.
RadioGel is unlike any other product as it is absorbed by the body shortly after entering the human body but not so early as to render the short half life isotope useless on its target. With this in mind, and as I have stated for probably a couple years now, it could likely need human testing for a variety of reasons. Remember it has to be as good or better than devices on the market today as well as be at least as safe.
Unfortunately for all of us I do not think any of us posting here have the remotest idea on FDA response timeline.
Jhonsong this is a very speculative stock play in my opinion. You take some time to honestly identify with your risk tolerance.
Good luck no matter what you decide.
Yes on warrents and/or dilution. I do not want to go into listing them all or their dates. Refer to the recent SEC 10Q for that. It is available on the Yahoo SEC tab. If you do not want to pay Edgar for it you could check the Nasdaq page, your own trading platform or with your broker if you use one. Other concerns is the company operating as a going concern. Revenues are "barely" being generated and grant funding is slim to none.
I am not aware of any news or conference calls scheduled. If I knew it would only be through inside information.
That volume was high but the stock fell 32% today from yesterday's close so any believers or contrarian investors were also snatching up shares. We all would like to know who made that "open" order that pushed that sell off. Limit sells would have been more controlled. Someone just "dumped" a million shares. Not good investing practice in my opinion, even if it was 1% of your total position in the company. Not cool thing to do to a micro cap, you can't even do a stop loss on it, that someone might willfully trigger with a short position.
I would love to hear a Zippy, Motto or Kayak opinion on this but I bet we are all stumped.
There were huge bids at .03 to .033 but they did not fill. Some retail kept hitting the Ask. The big buyer chased the Ask but never hit the Ask and did not get filled. That is weird to me but it also suggests to me that ADMD was not moving shares in the open market. They would have hit that 500k share bid. Now who in the heck was trying to buy that many shares? It was only what $15 thousand dollars but they wanted those shares. They were chasing the Ask from .027!
If you review the accumulation up to the announcement date, go back over a few months, you will see high volumes that were building as well as pushing the share price upward. When the announcement on the 21st I believe did not provide a deffinative answer at all but was just a response to classification. There were millions of share acquired as a "trade". The news did not ingender a positive short term outlook so a lot of traders, if not most by now, bailed on the stock. Depending on who you ask here you will get responses as to if the stock is oversold or not. The stock had risen from .037 at the low. At that time there was 100 million shares issued. Now there is 127 million.
Wonder if there will be a news release after the bell today. That was an aweful lot of action with a strong Ask here at the close for 415K shares at .0335. Why did that just happen? There are plenty of things for ADMD to update on, especially without a conference call after the 10Q.
I am expecting some news.
Someone is coming in big still.
That was a shakeout this morning. Team Ignore will hate it but that is what that was.
I hope some of you good guys bought that .027 or lower. That was the low market cap number as I mentioned before.
Ha Ha! Look at that, another Team Ignore TI reply. I bet the goofball is upset about my comments, and what looks to be exactly what is going on. Heck, I bet the stock closes at the open price today. Possibly higher!
Someone is picking up the Ask now. Lot of share buying. It looked like someone took the price down with pretty small trades so as to let someone else in to buy a bundle of ADMD.
Market cap got right to where I said it would. Now will it be the floor or not remains to be seen.