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Welcome. First Congrats.
How did you find out about Arch? Always curious on that. When did you find out about?
I assume you have read all the material on Arch....
So I first heard about Arch in Oct 2014. Coming on 2 years.
1930 was a great year !
ARCH THERAPEUTICS (ARTH) EXPANSION OF PRODUCT LINES AND INTELLECTUAL PROPERTY—THE REAL STORY OF 2016
Arch is focused on bringing to market a clear liquid that has been classified as a medical device known as AC5 with 200 +- potential applications.
While everyone has been focused on the successful first human clinical trials for AC5 the real story for 2016 for Arch is major expansion of Arch products and labels via intellectual property approvals of SIX MAJOR PATENTS granted in the last nine months. Arch is awaiting approval of still more patents.
Norchi’s August 18, 2016 interview talked of product line expansion.via intellectual property expansion beyond AC5.. What this means is that any JV in Europe will be for the AC5 product line and not for the others created. IMHO this is valuation creation for Arch shareholders.
No one has focused on this to date. These additional patents can only add to the value creation of AC5 and its 200+- potential applications. As mentioned before per SEC filings Arch requires $8 to $ 12 million of additional capital funding to complete human trials in Europe and USA for AC5.
Dr. Norchi stated in August 18, 2016 interview:
1) The list of how and where to further deploy the Arch technology continues to grow.
2) True value of Arch stems from it intellectual property.
3) Expansion of Intellectual property is value creation for Arch.
4) AC5 human trials is the first product and first application but a small step on a large valuation creation curve.
5) Desire to expand product labels
6) The Arch technology has the potential to be a real game changer for doctors and patients alike in reducing surgical times and reducing other risks….. resulting in better outcomes.
MORE SEE----details of six new patents
http://www.archtherapuetics.blogspot.com/2016/08/arch-therapeutics-arth-expansion-of.html
Elevator Summary of ARCH http://www.archtherapeutics.blogspot.com/
Follow the intellectual property of Arch. Sounds like we will see expansion of Arch product lines...... I guess beyond the 200 +- spplications for AC5. The pie grows !
$400,000 monthly burn rate
$ 5.7 million cash 6/30 + 1.9 million exercise of series E warrants minus $ 800,0000 for 2 months Equals $ 6.8 million or 17 months
Read my post about potential jv cash--
Need $ 8 to $12 million of additional capital for full Europe and USA clinicals per SEC docs (TINY)
It is all here:
Elevator Summary of ARCH
http://www.archtherapeutics.blogspot.com/
WELCOME--How did you hear about Arch?????
Future ARCH Financings
I am beginning to doubt whether there will be any future stock financings in light of what I am seeing in recent JV deals.
I see people are attempting to talk the Arch price down talking about stock financings. Look they had $ 5.7 million cash per recent 10-Q. I believe another $ 1.9 series E warrants were exercised recently. They burn $400,000 month.
Study these and note size of numbers and dream about ARTH. Imagine if they did a deal for just 50 of the 200 potential applications.
Remember we only need $ 8 to $ 12 million of additional capital to get all the human trials in Europe AND USA per SEC filings. A JV in Europe could take care of this easily.
Study these recent deals to see how big the numbers have gotten:
Little MEI Pharma rockets up on $25M cash injection, deep-pocket partner for PhIII AML cancer study (market cap $ 67 million---royalty in high teens)
"This morning, MEI $MEIP is taking the wraps off a development deal with Switzerland’s Helsinn designed to shepherd the HDAC inhibitor pracinostat through a pivotal study. MEI gets $20 million in near-term cash —$15 million up front with a $5 million milestone at the start of the Phase III — along with a $5 million equity investment. And there’s $444 million in milestones on the table for success, along with royalties that can be earned from Helsinn’s marketing efforts"
"Advaxis Inc. ADXS, +5.48% shares spiked 28% in pre-market trade Tuesday after the company announced a $40 million agreement with Amgen Inc. AMGN, -0.15% to develop and commercialize cancer immunotherapy treatment ADXS-NEO. The agreement includes a $40 million upfront payment to Advaxis and a $25 million purchase of the company's common stock by Amgen, along with sales milestone payments of up to $475 million and additional royalty payments based on global sales."
Interesting comment on ARTH ARCH from seeking alpha:
"Several observations: ARTH cannot fully publish data and then get an article in a peer-reviewed publication. Strategic partners look at peer-reviewed publications as being the litmus test of credibility.
The ARTH advisory group is not going to risk their scientific credibility by hyping the results of this initial trial so I place great emphasis on what they have to say.
Anyone who doesn't think a 41% reduction in bleeding is significant is a moron. ANYTIME you can reduce bleeding time, you do so. Period. Ask any surgeon.
Finally, any company in this space that shows even modest results is eventually purchased. I have no doubt that ARTH will find a strategic partner or get purchased and at multiples significantly higher than the stock price today."
Elevator Summary of ARCH http://www.archtherapeutics.blogspot.com/
Most of the items related to distribution or marketing will be handled by Arch's future partner---JNJ or Baxter
Look at the type of deal these companies did--imagine Arch going same for say 50 of the 200 AC5 apps
Little MEI Pharma rockets up on $25M cash injection, deep-pocket partner for PhIII AML cancer study (market cap $ 67 million---royalty in high teens)
"This morning, MEI $MEIP is taking the wraps off a development deal with Switzerland’s Helsinn designed to shepherd the HDAC inhibitor pracinostat through a pivotal study. MEI gets $20 million in near-term cash —$15 million up front with a $5 million milestone at the start of the Phase III — along with a $5 million equity investment. And there’s $444 million in milestones on the table for success, along with royalties that can be earned from Helsinn’s marketing efforts"
"Advaxis Inc. ADXS, +5.48% shares spiked 28% in pre-market trade Tuesday after the company announced a $40 million agreement with Amgen Inc. AMGN, -0.15% to develop and commercialize cancer immunotherapy treatment ADXS-NEO. The agreement includes a $40 million upfront payment to Advaxis and a $25 million purchase of the company's common stock by Amgen, along with sales milestone payments of up to $475 million and additional royalty payments based on global sales."
Not at all. This will be used in boxing and other brutal sports. Stops bleeding in seconds--seconds--clear It will change those sports.
It will be used by those on blood thinners as emergency backup.
I don't agree that the goldmine is surgery at all.
The goldmine is external uses by a mile. Things like Pressure Ulcers or Bedsores costing $ 10 billion in USA, Foot Ulcers, Burns and leakage issues.
So of the 200+- AC5 how many pertain to surgery? How many to external uses?
Another QUESTION
Why the delay in obtaining the CE Mark? Is Arch obtaining a specialized CE Mark that requires more time?
QUESTIONS
1) When is Arch going to lay out its gameplan of what they will be doing over next 12 months
2) Of the 200 +- applications for AC5 what % relate to external?
3) When if Arch going to list the 200 on their website?
4)What will this first human trial permit Arch to sell in Europe once CE Mark is obtained?? Bedsores? Foot Ulcers?
5) Please have a public conference so we understand the company better
6) Will the FDA allow some of the Euro testing? How about medical device classification by FDA for AC5?
Yes I believe so. Imagine being on blodd thiners with comfort of having supply of AC5. As Dr. Norchi has mentioned in his presentations and in the company presentation product has high margins. So price can be adapted for this use IMHO.
As I have mentioned this should change boxing and other brutal sports completely.
I was told all the physicians involved in the human clinical thought the 41% faster on skin lesions was a Huge Deal as they do not bleed a lot--2 to 3 minutes.
ARCH IR CONTACT
TRY THIS
CONTACT INFORMATION PCAdvisory : Kirin M. Smith
Ksmith@pcgadvisory.com D: 646.863.6519
Also http://www.archtherapeutics.com/contact
I believe the human trials we just finished will allow all external applications. That is why I want list of entire 200 applications and as you point out a game plan. EMAIL the Company..even if you get no response they are reading... Someone has been getting a hold of IR person. Anyone here???
All are quite WELCOME.. Finding companies like ARTH is RARE
I want conference calls so everyone can be on the exact same page.
Plus we can see Dr. Norchi shine. Remember he has all his eggs here.
Follow his lead.
Study these and note size of numbers and dream about ARTH. Imagine if they did a deal for just 50 of the 200 potential applications.
I have been blown away at the size of some of these recent deals.
Remember we only need $ 8 to $ 12 million of additional capital to get all the human trials in Europe AND USA per SEC filings.
Study these recent deals to see how big the numbers have gotten:
Little MEI Pharma rockets up on $25M cash injection, deep-pocket partner for PhIII AML cancer study (market cap $ 67 million---royalty in high teens)
"This morning, MEI $MEIP is taking the wraps off a development deal with Switzerland’s Helsinn designed to shepherd the HDAC inhibitor pracinostat through a pivotal study. MEI gets $20 million in near-term cash —$15 million up front with a $5 million milestone at the start of the Phase III — along with a $5 million equity investment. And there’s $444 million in milestones on the table for success, along with royalties that can be earned from Helsinn’s marketing efforts"
"Advaxis Inc. ADXS, +5.48% shares spiked 28% in pre-market trade Tuesday after the company announced a $40 million agreement with Amgen Inc. AMGN, -0.15% to develop and commercialize cancer immunotherapy treatment ADXS-NEO. The agreement includes a $40 million upfront payment to Advaxis and a $25 million purchase of the company's common stock by Amgen, along with sales milestone payments of up to $475 million and additional royalty payments based on global sales."
Arch Therapeutics ARTH Drill Down
There is substantially less risk in ARTH today than last week with human trials in.
Arch has only 4 employees so impossible to communicate.
Therefore we ALL need to request public conference calls on events like today. Please encourage them to have a public conference all asap. This is important and the time has come for Dr. Norchi to shine on this type of venue.
I was told all the physicians involved in the human clinical thought the 41% faster on skin lesions was a Huge Deal as they do not bleed a lot--2 to 3 minutes.
This was an easy first step AC5 bleeding challenge. The market assumed same. A major arterial bleeding event using AC5 will bring in the major investors.
As far as the CE Mark they are applying for a "top line" CE Mark which requires a little more time.
What I want to know is how many of the 200 +- AC5 applications will this human trial permit? So the big dollar low hanging fruit (my term) is external applications: Pressure Ulcers (bedsores)--2.5 million cases in USA costing $ 10 BILLION, Foot ulcers, Burns, Colon Surgery leakage issues, etc. IMHO the external $ uses dwarf the surgery apps. What are the 200 applications????
Right on. There is so much due diligence on Arch. Go to stockgumshoe.com and read the 3400 comments on Arch for $ 49
Purastat been addressed so many times. It is the Model T Ford next to AC5. Virtually no sales. No human trials. Actually one failed human trial. Look at all the recent Arch patents. Those original MIT patenta are dinosaurs. Arch perfected the science.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=122879986
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=122877958
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=122905497
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=122877958
They have four people with a huge plate full of work.
There are no equivalent products.
How many clear liquid medical devices have you heard of ?? NONE.
A CLEAR LIQUID noncoagulant homostatic agent classified as a MEDICAL DEVICE.
There are many other hemostatic agents, but:
* They all rely on using the patient's blood,
*They all take minutes to stop bleeding, not seconds
* None of them create a clear seal that a surgeon can see through
* None of them work just as well on people on blood thinners
* None of them work in every situation where bleeding has to be stopped
Arch's AC5 product solves all these problems.
Arch Therapeutics Science
http://sciencebehindac5.blogspot.com/
"NOTHING COMPETES with AC5!!!! Get it? Got it? Good. I have trawled and published in this field my whole career, and know molecular coagulation like few do. NOTHING COMPETES with AC5!!!!"
Elevator Summary of ARCH http://www.archtherapeutics.blogspot.com/
Ask about identifying on website the 200 +- applications for AC5
So I pursued why Maxim. I found out that Arch has no further relationship with them. I believe Maxim came to Arch and said we have $2 million plus $ 2 million for warrants and we are willing to do this next week. It was a very quick financing.
Plus Maxim was willing to take only a .75 warrant for each share.
I do not know the above for sure but putting together what I do know.
I think it was too good to pass up. If they exercise 5/26/21 warrants in 2016 that is a great thing to shareholders. Cash in 2016. Less future dilution.
The Chairman is a figurehead who lives in California. If you think otherwise sell the stock.
Dr. Norchi is the operator and decision maker.
If you know Dr. Norchi he always desires to overperform. Once this gets rolling we will see press release after press release.
Look back when every rat and pig in America was being tested with AC5 we had news constantly. As I have stated those rats and pigs rejoiced when Arch moved on to humans.
What I want is a list of the 200 +/- AC5 aplications. Then we can determine our target markets and the billions we are going after. Please all ask for that
So you do not need human trials results to obtain CE Mark. Companies have obtained CE Mark in less than two months without human trials.
I discussed this point with Company. They could have gotten CE Mark years ago but it would mean nothing without human trials. No doctor would use product without human trials.
I wonder if they are not trying to get both at the same time.
If one has confidence in science it is everything. Study closely.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124140822
CEO 1000% This is key doc describing him. Have met once. Chairman is out of California --not critical. CEO critical and decision maker.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124100038
Hopelessly bias.
Yes. But unlike Closure Arch has 200+- applications.
Imagine the Arch valuation if they broke up the 200 and did JV's with various Pharmas. Pressure Ulcers / Bedsores with Y. Surgery apps with X.
The longer Arch stays public the bigger the valuation.
So 500 million divided by 168 million is $ 2.98. So it is a 4.65 bagger from here.
Arch fully diluted shares is 168 million. Shares, warrants and options.
Closure Medical was a hemostasis company sold to JNJ. Thus the comparison in market cap versus sales price.
Buy Out Question
At $.675 market price Arch has a market cap of $113 million on a fully diluted basis of 168,061,159 shares.
So Closure Medical was sold to JNJ on 3/4/05 for $ 370 million. So we are only at 30% of that number.
Closure’s Dermabond is used in JNJ Liquid Band Air. Recall that some of the Closure’s Key People helped develop Arch’s AC-5.
I would argue that Arch’s 200 +/- applications are much deeper than the Closure apps. Most Arch's applications apply
to external uses such as Pressure Ulcers (bedsore), Foot Ulcers, Burns, etc. The external uses are the low hanging fruit
in which the current Europe human trials apply,
I believe that IF (BIG) Arch held out for a period of time they could approach $ 1 billion market cap but I am probably dreaming. In that case we would be 11% of the way there.
Summary of ARCH ARTH: http://www.archtherapeutics.blogspot.com/
" i believe patent protection timeline is limited" Not True
All of the relevant patents have only be issued recently. Arch hired the best peptide scientists in the world and perfected AC5 when it came out of MIT. More patents are pending per news releases.
Arch has old Rutledge MIT patents that as Rutledge discusses in his video were not very good versions of AC5.
Dr. Rutledge Ellis-Behnke PHD
Arch Therapuetics 2015 in Review
22 Press Releases in 2015
27 Press Releases in 2014
Dr. Terrence Norchi did Eight presentations in 2015
Arch Therapeutics ARTH---Looking for Bear Case -- Note ARTH is his top pick
https://biotechinvesting.info/2016/08/01/arch-therapeutics-arth-looking-for-a-bear-case/
ARTH / BIOTECH / POSITIONS
Arch Therapeutics (ARTH) – Looking for a bear case
AUGUST 1, 2016 BIOTECH INVESTING LEAVE A COMMENT
The biotech stock I get most asked amount, to my surprise, is Arch Therapeutics. The reason for the surprise is my belief that this was very under the radar. It is, after all, a micro-cap, OTC biotech with an $82 million dollar market cap, a 61 cent sales tag and an average daily trading volume of just over a million shares (7/31/2016). I suspect that part of the newly found interest has to do with the fact that as early as March, this was selling for under 20 cents/share.
Arch Therapeutics has a biocompatible synthetic peptide that controls blood and fluid loss during surgery called AC5 which is still in clinical trial phase. This stuff has surgeons licking their chops (apparently), and is protected by quite a few patents (exclusive worldwide). AC5 is transparent, which allows surgeons to see what they’re doing during surgery, and there is nothing else like it, which makes it a candidate to eventually be the new standard of care for surgery. There is no doubt that it works, and that it is superior to anything on the market now, but with the FDA, you can never be too confident about approval. That, to me is the most serious risk here. There is also always the risk of another company coming out of nowhere with a competing product that does the same thing, only better, but there is nothing on the radar that I know about and it doesn’t seem likely that something with so much potential would be kept secret for long. If anybody knows of any serious competition, please do share.
For a little more on AC5, here is an SA article that will give you some more details.
One of their co-founders, Terrence W. Norchi M.D. wrote this article about AC5 for a medical publication. As you can see, he’s promoting this product to doctors already. He also owns a considerable amount of shares, considering his income. You can see his compensation details here.
They released their completion of patient enrollment of a human trial in early June and I’m anxiously awaiting its results, but they are supposed to come out later this summer. They claim in their most recent webcast that they plan on getting FDA approval in Europe by the end of 2016. According to their webcast, they are just waiting for the trial results to announce commercialization plans. They are currently putting together a package of information for the FDA which already contains all of the safety data that they need. Now they just need to show the effectiveness of AC5 which almost seems like a formality at this point. This will almost certainly make billions in sales if it ever reaches the market, so the upside is huge.
Here is a slide from their May 5 webcast which shows the drawbacks of competing methods of hemostasis compared to AC5:
3__SlideHMFGDH10
OTC stocks are inherently risky and ARTH seems to have a little bit of hype going already which is usually a red flag, but I’m not feeling too uncomfortable with this level of risk. Even if AC5 was only worth $1 billion in potential earnings (it’s not), the market cap still only signifies a 1 in 12 chance that it will actually be approved, so I think that the risk/reward ratio is really good here.
So, what’s your bear case? I’d like you guys to find a good reason to avoid this stock. I haven’t found a compelling reason not to own an amount that would make me very happy if AC5 ever finds its way to market. Thanks for reading and as always:
Happy Hunting!
https://biotechinvesting.info/my-biotech-positions/
ARTH (hidden gym – top pick based on science of AC5)****
Pete says:
JULY 26, 2016 AT 12:43 AM
Like your top picks ARTH and CYDY. Just doubled my position in ARTH today and almost bought more CYDY as well, but just couldn’t pull the trigger. CYDY is the riskier of the two IMO, so mulling it over, feel like I need more news before I buy more.
Biotech Investing says:
JULY 26, 2016 AT 1:39 AM
I don’t blame you on CYDY. It’s a bit scary for me too which is why I don’t have more. ARTH has a much more clear and simple path. Both have so much upside, it’s not even funny.
Arch's Form 10-Q is out Thursday.
Random comments
So I have been through the Form 10-Q . For me the disappointing item I saw no exercise of the Series E warrants by Maxim investors. Perhaps they are doing it now. That is another $1.9 million cash. I had thought that they may have exercised and sold on July 14, 2014 the day after the S-1 registration became effective. Their is a lot of paperwork to exercise warrants so that was wishful thinking on my part.
On page 31 they say they will need an additional $ 8 to $ 12 to complete all US and Europe testing…… Based upon the old numbers it should have been $ 6 to $ 10 million. Oh well it is still small.
They have $ 5.7 million of cash on 6/30/16. So if Maxim exercises the Series E May 2021 expiration warrants it will add $ 1.9 to the cash pile.
My recent thought about AC5 enhancing the sport of boxing and other brutal sports…. which is going to be very interesting….
One other question is let’s say you have a bedsore or a major open wound and you apply AC5 to the area do you feel it at all since it is a barrier? Imagine not feeling the burning that is now felt with open wound.
Arch Summary HTTP://WWW.ARCHTHERAPEUTICS.BLOGSPOT.COM/
Re: Arch Manufacturing. This comes from Dr. Kss--see below--over a year ago.
"Norchi has deep contacts in the world of contract manufacturing. Norchi said that Arch had spoken with many candidate contract manufacturers, and wanted one that could do scaled-up liquid phase peptide synthesis on both sides of the Atlantic equally. A contract is in place, and this organization is now making AC5 stocks. Norchi felt it would imprudent to name right now the manufacturer or the cost per unit for manufacture, but assured us that despite the relative expensiveness of making AC5, he is confident a price with considerable profit margin that the market will easily bear without drama or protest can be set. Arch has a consulting advisor who is the author of the leading textbook in biochemistry on methods of peptide synthesis."
Arch Therapeutics Science
http://sciencebehindac5.blogspot.com/
Elevator Summary of Arch http://www.archtherapeutics.blogspot.com/
Look at the recent S-1 registration
S-1 SEC registration statement filed June 24, 2016---
http://ir.archtherapeutics.com/all-sec-filings/content/0001144204-16-109625/v442350_s1.htm
Preclinical Development
We have recently completed the components of our planned preclinical program for AC5 that were requried before we started our first human safety and performance trial, which was initiated in early 2016. We are focused on scale-up of selected manufacturing methods and formulation optimization. In parallel, we are conducting further in vivo and in vitro tests, while additional testing will continue after completion of manufacturing scale-up and formulation optimization steps and the clinical trial. Self-assembling peptide manufacturing and formulation optimization are challenging, and any delays could negatively impact anticipated clinical trial and subsequent commercialization timelines. In order to market and sell AC5 and other Arch planned products, successful human clinical trials, additional testing, and regulatory approvals and certifications will be required. A co-founding inventor of certain of our technology, Dr. Rutledge Ellis-Behnke, performed a significant portion of the early preclinical animal experimentation conducted on our technology. Some of the most significant findings from Dr. Ellis-Behnke’s studies have been published. Additionally, through collaboration with the National University of Ireland system, preclinical bench-top and animal studies have been performed in Dublin and Cork, Ireland. As a continuation of our commitment to our product development we entered into a collaboration agreement with National University of Ireland Galway (“NUIG”) in Galway, Ireland on May 28, 2015 (the “Project Agreement”). Pursuant to the Project Agreement, NUIG will provide, via the CÚRAM Centre for Research in Medical Devices (“CÚRAM”), a new major national research center headquartered at NUIG that was established in January 2015 as part of a six-year grant from the Irish government, personnel, infrastructure support and grant funding in connection with a research program intended to facilitate the continued development of the Company’s core technology (the “Project”). Under the terms of the Project Agreement, which has a term that will end upon the earlier of the completion of the Project or the sixth anniversary of the execution date of the Project Agreement, we may contribute up to a maximum of two hundred and fifty thousand euro (€250,000) to the Project per year, and NUIG will match such funds at a 2:1 ratio using funds allocated to NUIG by Science Foundation Ireland’s (“SFI”) Research Centres Programme. In addition, while NUIG will initially retain ownership of all intellectual property developed in connection with the Project (collectively, “Project IP”), any such Project IP that was either based on or derived from our existing intellectual property (“Derivative IP”) will be assigned back to us for a nominal fee. For any Project IP that does not constitute Derivative IP (“Non-Derivative IP”), we will have a right of first negotiation for an exclusive license to such Non-Derivative IP on customary terms for agreements of that nature including royalties on net sales in the low single-digits, in each case subject to a grant-back to NUIG for research and academic purposes. We have also engaged, on a fee for service basis, several private third party facilities in the United States and abroad to perform certain preclinical bench-top and animal studies, which are often conducted with assistance from our scientific team, and we continue to engage third parties for such services as needed and as appropriate.
The difference between Purastat with no successful human trials and a two month CE mark and AC5 is night and day. Purastat is like JELLO and not clear. They spent zero improving. Used for different purposes.
I have talked before about all the additives that will be put with AC5 and you are correct.
Yes in my dream senario....which is why it is a dream. How did you hear about this? Why are you a "ARTH stock Lover?"
Buy Out Question
At $.675 market price Arch has a market cap of $113 million on a fully diluted basis of 168,061,159 shares.
So Closure Medical was sold to JNJ on 3/4/05 for $ 370 million. So we are only at 30% of that number.
Closure’s Dermabond is used in JNJ Liquid Band Air. Recall that some of the Closure’s Key People helped develop Arch’s AC-5.
I would argue that Arch’s 200 +/- applications are much deeper than the Closure apps. Most Arch's applications apply
to external uses such as Pressure Ulcers (bedsore), Foot Ulcers, Burns, etc. The external uses are the low hanging fruit
in which the current Europe human trials apply,
I believe that IF (BIG) Arch held out for a period of time they could approach $ 1 billion market cap but I am probably dreaming. In that case we would be 11% of the way there.
Summary of ARCH ARTH: http://www.archtherapeutics.blogspot.com/