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...thanks guys....wow my mind blown lol ...that first example i list from the FDA site is like an exact match to what ADMD is aiming for with its Class II device!
Wooooooooooo!
Ok gotta go het a hair cut see you all later!
Tim222: I found it! Look at these FDA Class II description for devices, therapies, procedures etc(!!!): sorry a little excited as your post forced me to do more DD, lol
First of all: thank you Tim222! What i found just blew my mind on the FDA site.
-- Guys, not only does the Class II classification that ADMD's device is going after fit perfectly in with so many Class II FDA ones below (and some very similar ones !) -- looking below at these examples -- well a Class II classification seems a very good possibility and makes the most sense.
lol it aint just wheel chairs in FDA Class II brah! Check it out Tim222:
...first of all this is what ADMD. Is trying to get reclassified:
Yttrium 90 RadioGelâ„¢ and Polymer Seeds.
The future of radioactive brachytherapy.
Advanced Medical Isotope Corporation has obtained an exclusive license to eight (8) patents for injectable RadioGelâ„¢ technology for use in high-dose radiation therapy. The license was granted by *Battelle pursuant to an option between Battelle and AMIC announced in February 2011.
The Agreement grants AMIC an exclusive license to make, have made, use and sell a RadioGelâ„¢ system including an injectable, water-based biodegradable polymer that delivers Yttrium-90 microspheres directly into tumor tissues. The solution warms to body temperature quickly after injection and then polymerizes into a lattice that traps the Yttrium-90 microspheres in place. High-energy beta particles from Yttrium-90 efficiently irradiate cancer cells within the targeted volume but very little radiation escapes. This feature maximizes the overall radiation dose to cancer cells while minimizing radiation exposure and associated side-effects in nearby normal tissues.
KENNEWICK, Wash., Dec. 23, 2014 /PRNewswire/ -- Advanced Medical Isotope Corporation ("AMIC") (OTCQB: ADMD), a late stage development company engaged primarily in the development of brachytherapy devices and medical isotopes for diagnostic and therapeutic applications, today announced that it has filed a de novo submission with the Food and Drug Administration ("FDA") for marketing clearance for its patented Y-90 RadioGelâ„¢ device pursuant to Section 513(f)(2) of the U.S. Food, Drug and Cosmetic Act (the "Act").
By filing the de novo submission, the Company is seeking reclassification of the product to Class II.
http://isotopeworld.investorroom.com/2014-12-23-Advanced-Medical-Isotope-Corporation-Files-a-de-novo-Submission-for-Y-90-RadioGel-Device
Now guys read below(!)....these are alllllllll Class II !! There are many more in many medical fields @ Class II ...but i found these to be very similar to ADMD's device and therapy...as they are into radiation therapies and delivery devices too:
And dudes...lol...this first one listed below....well is that as close of a medical match as one could find for ADMD?? Even better ::: ADMD uses a BIODEGRADABLE capsule unlike the below listed gold, titanium, steel or platinum that STAYS in the body:: Wooooooooooooooo!::
--------------------------------------
PART 892 -- RADIOLOGY DEVICES
Subpart F--Therapeutic Devices
Sec. 892.5730 Radionuclide brachytherapy source.
(a) Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.
(b) Classification. Class II.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.5730
------------------------------------------
PART 892 -- RADIOLOGY DEVICES
Subpart F--Therapeutic Devices
Sec. 892.5050 Medical charged-particle radiation therapy system.
(a) Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
(b) Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 892.9.
[53 FR 1567, Jan. 20, 1988, as amended at 64 FR 1125, Jan. 8, 1999]
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.5050
PART 892 -- RADIOLOGY DEVICES
Subpart F--Therapeutic Devices
Sec. 892.5300 Medical neutron radiation therapy system.
(a) Identification. A medical neutron radiation therapy system is a device intended to generate high-energy neutrons for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment support, treatment planning computer programs, component parts, and accessories.
(b) Classification. Class II.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.5300
SUBCHAPTER H--MEDICAL DEVICES
PART 892 -- RADIOLOGY DEVICES
Subpart F--Therapeutic Devices
Sec. 892.5750 Radionuclide radiation therapy system.
(a) Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.
(b) Classification. Class II.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.5750
...and brotha, check out this below FDA Classification for a mere Class I device: hard core radiation therapy i guess can even be classified as a Class I by the FDA:
SUBCHAPTER H--MEDICAL DEVICES
PART 892 -- RADIOLOGY DEVICES
Subpart F--Therapeutic Devices
Sec. 892.5740 Radionuclide teletherapy source.
(a) Identification. A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The device is intended for radiation therapy, with the radiation source located at a distance from the patient's body.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 892.9.
[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, 2001]
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=892.5740
Thanks for your concern ! It just made me DD even more, and seeing alllllll these FDA Class II listings (and many more on FDA site in Class II in all kinds of complex categories and procedures - too many to list but browse through the FDA site when you get a chance) -- HAS ME MORE CONVINCED then ever that ADMD can also get Class II: FITS RIGHT IN WITH ALL THE ABOVE, eh?
Good post bro. I just kick myself for not finding this while in Trip Z lol......and many many people would say the same thing. Thats why any big dips have been good opportunities to get in for sideliners.
Though with the huge 10 mil and 5 mil BIDS the last two days, those dips to .003's may now be gone.
Good idea Doc...! The decision may come today or two weeks ....like i think after all the shares are returned 10 business days after the May 1st 8k. So lets be ready eod from such negative manipulation.
...would have been 5th GREEN or even day in a row: i will gladly take a tiny RED day,mjust for charts sake. If we werent gonna run over ..005 then might as well!
Yeah really.....and as others have mentioned....i think they want to wait 10 business days from May 1st and that 8k......and get all the 'illegal' or misnomer shares back first, thereby lowering the OS ...then release the news...which would be mid-month.
Par value as stated for conversion was supposed to be @ .001 --- so say someone converted 10 million shares @ .0005 -- they need to return 5 mil.....: this is a big deal that could greatly impact the pps of course, and comes at such the perfect time.
But who knows, we aint insiders so it could drop any single solitary moment-!
I wonder too. It was an incredible time, and since i missed the dot.com boom - the MJ boom is all i know for a pinnacle penny stock moment.....when 5 stocks a week or more it seemed flew up hundreds of percent, with enough volume to make serious cash.
Only if those people and that money stuck around....those short-sighted scared people lol......cause look what it did! It guaranteed that many stocks would run each week, that ASK's would be smashed, that BIDs would recover when hit hard and still go up. And there was plenty of time in those week long or months long runs to safely get off a bus and onto the next one.
All that volume in the Penny Market should have lead to a positive cycle, where more money came in, more people made money, so they put that too back in the market and etc and this should have grown, not extremely shrunk to almost a defunct market in comparison -- so quickly?
...i still dont understand it....: what a waste of what could of been. Though it didnt help that like 100 new penny stocks magically became MJ stocks overnight during this time, many that we know now have done almost nothing ....they stole away a ton of money.
Sooooooo...we just need to find that one or two now that have the Story, the future huge news: only, and pending.....and the volume/popularity: all others can get stuck with no real and sustained volume and runs these days.
....BMAK with that 10 milly is just awesome. Ive never seen him this high up, with that many shares on the BID. In fact, i rarely see him on the BID with anything more then even 500,000...wanna say mostly just these little 10,000 bids....lol...And CHDN still untouched 5 mil waiting on BID too - sweeeet!
Comparing Biotech Market Caps: from Trials to Aprroved:
(..this is a repost and rehash of a couple posts i did from yesterday, i think pertinent...):
--- a new Biotech ETF that was set up last year. They only invest in two groups of Biotech stocks: ones that are still in Clinical Trials - which as we all know takes years.....and the other group are those companies that have biotech approved products:
http://bioshares.com
...i just went to my charts, choose randomly tickers from each side, and on the side of 'Clinical Trials Stocks' i found huge Market Caps -- many still over $500 million to over a Billion. On the 'Approved Stock' side i found ones w Market Caps most all over a Billion. ...with some with Market caps as of today just under $20 Billion.
...is there another Market Sector where valuations can run so high, on sometimes so little? Biotech is where the money is guaranteed to always be at.
The incredible thing here with ADMD, is that the initial Clinical Trials from the '80's and '90's are over for their kind of Y-90 therapies -- we are just waiting on FDA to be Cleared for what category they should be classified under when hits medical market; we dont have to wait like IHub other popular Top 15 Most Read stocks CT*X and PP*M and PPC* -- for Clinical Trials to be done. Yes, some are in Phase III - but no guarantees that they will be Approved...and they still have to wait months or years. ADMD does not have to worry about passing Clinical Trials.
ADMD's Market Cap now is under $10 million.......and we arent waiting on some FDA approved bandages, side treatments, lotions etc...we are waiting on cancer killing new Modern day radioactive isotope Y-90 novel therapies: upon approval they will have a more exciting and modern/revolutionary biotech product then some Nasdaq biotechs(!!) .....let alone huge advantage over all those Naz biotechs still in Clinical Trials w no product.....yet their Market Caps are again in the hundreds of million of dollars.
For example, CT*X has a Market Cap of around $280 mil - with no products out.
PPH* has a Market Cap around $250 mil with no products out.
ADMD has a Market Cap lol below $10 million....and is waiting on mere reclassification from FDA. -- on verge of green-lighting their state of the art therapies (!)
...btw PPC* has a Market Cap of only $12 mil....but Clinical Trials Phase I --- have not even begun yet - looks very promising though....but how many years could that take?
Man, the opportunity here is immense, short and long; for the impatient and the patient. Cause yes everyone will profit take on way up with approval, but in time w approval -- ADMD should attract big biotech Naz money in the following months, to bring its Market Cap up to at least $100 mil ...but fair biotech industry value would but a functioning modern therapy like this, as we see above, closer to $500 to $1 billion(!) in time, yes?
...nice churn around .005 today!
....ADMD simmers below the Breakout surface and RSI just under 70: i like where we are at, and new buyers will have to start hitting the ASK to really get what they want.
Thanks. And a month later July '14 they PR'd about Battelle owning the 11% ...so maybe they own just under 20 mil? ...and again i dont know how it works, but maybe they could have bought more in the last year, especially when Trip Z Common Shares?
If not....still though they are invested with a nice chunk - and thats just all good.
Ok good night to you!
Nice find StockNinja33! Partnered with Battelle and Battelle is some percentage owner of Common Shares of ADMD -- as PR'd last summer 11% -- dont know if they have been buying more throughout the dilution since then to keep this 11% Ownership - if not they own at least around 15 million shares. Either way its great to have them on both ends -- says they believe in their work....as they should w their expertise.
Yeah your right - i wonder what percentage they own now then ? With OS increase since they bought in , sorry i didnt factor that in ...in my excitement lol -- i wonder if they continued to buy to keep 11%, or maybe they own what 5% now?
http://www.battelle.org : check it out every single person invested here or looking to get in. Your right Doc -- a company this big with 90 years experience, $6.2 billion in revs ....i doubt they would risk 11% ownership of Common Shares here, and collaborate so much with ADMD and help develop their patents and therapies!
What a partner to have ....crazy.
Cool. Also they own 11% of the Common Shares, just like all of us here, of ADMD....
Always like it when a company that big has the same risk we Common shareholders do.
....Battelle to me seems like lol Tony Stark Industries from Iron Man ....this company has been around since 1922, is a non-profit trust company.....to make a better world.
And they are into many cool things, innovations, advances, cutting edge, etc.
....oh yeah did $6.2 Billion in revs last year too...lol
You work at Battelle? ...now thats cool man. What a company. I have just began looking further into them...being they are partnered with AMIC/ADMD, and are last known 11% owners of ADMD.
...its interesting DTGoody, that two biotech stocks are in the IHub Top 11 'Most Read' and trade in the dollars: PP*M and CT*X. Former has a $242 million dollar Market Cap and the latter has a $290 million Market Cap.
and they both are in Clinical Trials. there is no guarantee that they will pass hope they do they look like good needed drugs and therapy's.
Point is the Market Cap here is less the $10 million......for what would be the newest FDA approved Y-90 Modern day cutting edge cancer treatment .....Clinical Trials on Y-90 were already done in '80's and '90's. yes there are other Y-90 Clinical Trials being done as it is a future branch in medicine for treating cancers -- but ADMD is NOT waiting on a Clinical Trial ...if one reads those two Boards above ...well Clinical Trials take years and years. Here is an excerpt from CT*X DD...:
.... So if Cellceutix can have their first patient enrolled before the end of the summer that would be fast in the world of antibiotic clinical trials. And that would be with many other irons in the fire including a major oncology drug in a phase 1 study and possibly two other phase two trials (Prurisol and Brilacidin-OM) while Tetraphase and Achaogen were just working on one antibiotic each.
The lack of patience of the average investor is amazing. A little patience will be rewarded....
...and that stock is $2.50 .....and we have more immediate huge FDA news pending.
Here with ADMD, we are waiting on a reclassification that will hopefully pass.....and we dont have to wait years....: in fact we are overdue for FDA decision.
IF we get approval, i will post in a whole new light, and compare ADMD to any Biotech and Market Cap out there who also has FDA approved oncology therapies ...especially on the cutting edge.
Cause many of those companies out of Clinical Trial and into actual use of their long developed products -- well their Market Caps are in the billions.
..thanks twosecure good post and reminder - people should really re-read this every now and then.
With a hot and popular stock, I like every several days or so an even or RED day down one tic: even though we havent even hit the hot RSI zone of late of 70 -- this keeps the chart cooled and folks we are free now to have a run into the weekend....many days before overbought and say the RSI hits 90's and stays there for a bit.
AT*N had these key minimal RED days and even days from .008 to .34 cents three years ago...they even lulled many to slleep in mid-Jan 2012 and scared off a lot of people too -- : it is the key, though, to long sustained pps runs, where then the most people possible benefit: and being the worlds cheapest public, immediately pending modern cancer treatment company ....ADMD has the story and the facts for an epic biotech run.
Speaking of run, im gonna go jogging now ...with a ron burgundy soft 'j' lol...
....BMAK w 10 mil on BID @ .0041 w ADMD : rare. Also, a few other MM's not just king NITE or ETRF w big bids since last Friday, over 2 mil.
Good to see you here lowman! Interesting chart and interesting BIDS...
...yes you dont see that big of BIDS over .003 very often -- and especially and best sign of all: several MM's not just one has them.
Sweeeeet!
...man a .005+ close would be sweet!
...yeah krazy.....good! lol
...lol thanks for that, wow, profound contribution - :)
Yes, this is an extra-ordinary opportunity to buy a significant and modern biotech stock under .005. The big BIDS by many different MM 's point to this reality.
...dang dude, you dont see BMAK with 10 mil on the BID like that everyday...
...i hear you, but check out this website i just found.
Its a new Biotech ETF that was set up last year. They only invest in two groups of Biotech stocks: ones that are still in Clinical Trials - which as we all know takes years.....and the other group are those companies that have biotech approved products:
http://bioshares.com
...i just went to my charts, choose randomly tickers from each side (after of course hitting each tab to see the tickers) and on the side of Clinical Trials i found Market Caps many still over $500 million to over a Billion. On the 'approved and selling' side i found ones w Market Caps most all over a Billion.
The incredible thing here with ADMD, is that the initial Clinical Trials from the '80's and '90's are over for their Y-90 therapies -- we are just waiting on FDA to be Cleared for what category they should be classified under when hits medical market.
ADMD's Market Cap now is under $10 million.......and we arent waiting on some FDA approved bandages, side treatments, lotions etc...we are waiting on cancer killing new Modern day radioactive isotope Y-90 novel therapies: upon approval they will have a more exciting and modern/revolutionary biotech product then some Nasdaq biotechs(!!) .....let alone huge advantage over all those Naz biotechs still in Clinical Trials w no product.....yet their Market Caps are again in the hundreds of million of dollars.
Man, the opportunity here is immense in long run. Cause yes everyone will profit take on way up with approval, but in time ADMD should attract big biotech Naz money in the following months, to bring its Market Cap up to at least $100 mil ....which would be still waaaay less then Naz biotechs with cancer killing new and modern products on the market.
Yep, great call and just wish i bought when you bought lol....thats why any big dips will just let a lot of people in who wanted in. Like the last one to .002 area. I added 200,000 more today and locked those GTC for 60 days too-!
...thanks DTGoody! ...i appreciate that v much and likewise with your posts bro!
...im thinking around that timeline too, to maximize share value here for us and for Insiders and Debt Holders...like Cadwell who owns most!
...yeah its like the perfect SS setup before big news, the biggest news in this companies history : all these many tens of millions and maybe hundreds of millions of shares returned, which were converted wrongly below .001.
And that...after 5 months of serious Accumulation looking at that stat on the 6 month chart....then becoming the Most Read and popular penny stock on IHub, and probably in the world as its often the only penny stock on StockCharts.com homepage now most days and 'most searched' along with the Apple's, FB and Googles of the stock world.....
Perfect Storm of a set up this would all be, if we get approval....and look back at all these clear and obvious events leading up to approval: we would be like: 'dude it was staring us all in the face, why didnt i buy more!' lol
Guys:...the more i think of the last 8k and '10 day legal return of shares' -- and re-read it...:
i almost think im looking at a 10 day countdown clock to when the news will be dropped.
Cause wouldnt the company and us all, NOT want those illegal shares in the SS when and IF FDA approval news hits?
Debt holder basically were because of an error, converting shares below the floor limit that was .001 a share.
Guys, that means if a share was converted say @ .0005 - then if 10 million were converted at that, 5 million would have to be returned.....yes?
So 10 business days, is the time limit upon receiving this notice for the shares to be either returned, or if not the company automatically makes the choice for them and adjusts the SS.
I need to think about this more, but any thoughts? Cause though the news then may be delayed to later in this month IF this is the case, ADMD would then have MANY less shares in the SS, making the spike and eventual long run in pps that much more possibly: Epic.
Either way: i look at the DD, know this is a significant FDA biotech modern new therapy on verge of being approved: and am holding all and buying on the dips....i can wait for whatever till we find out yes or no. But even if the news hits say in a week or two, every day now the ADMD SS may be shrinking, by many tens of millions of shares that are being returned, cause they were converted below the legal .001 par value: woooooohoooooo lol
...Good Morning!: Like yesterday good to get the RED dip outta the way early - this will just bring in many more from the sidelines.
ha welcome szj3m2 and welcome to IHub! MM for you...maybe someone else can give u one and you will have more Member Marks then posts lol
ok Good Night all - ADMD only grows in popularity day by day now .....very exciting!!
...bro another day, another time 'ADMD' is the only penny stock on Stockcharts.com's homepage: Most Searched tickers next to the Apple's and Googles and FB's and other $10 to $50+ stocks.....:
http://stockcharts.com
Being a hot biotech on verge of a big FDA decision, not only could this continue, but with approval continue for awhile.
Thanks you too! Good night!
Nice post uranium-pinto-beans.. and oh so true - to quote that article:
. .... Your family is not going to remember you for all the great trades you made, or for calling the top for $NUS at $140 or $PSMT at $125. They'll remember the time you spent with them. Of course they'll remember you for the food you provided for them and the roof over their heads, but they'll also remember you for all the time you spent with them. You NEVER get that time back.
Amen...and why i go silent for days and weeks sometimes this year on stocks : Life, fam and friends calling...which is Time always well spent. Its something i always struggle with, the thrill of penny stocks but the mostly dead days but soooo many hours spent here when i could be doing more. Though w my IPad i often do fit in many things during the day so not just cooped up inside alone staring @ IHub lol ---( thanks again for the millionth time Steve Jobs!).....
...and thanks uranium for the post - great perspective and reminder.