Discussion page for Arch Therapeutics (ARTH)This page is for discussion of Arch Therapeutics (ARTH).
This is a discussion topic or guest posting submitted by a Stock Gumshoe reader. The content has not been edited or reviewed by Stock Gumshoe, and any opinions expressed are those of the author alone.
Love Cleveland financial info. Awesome to see you again!
Cleveland – Welcome back my friend.
$ARTH
New Theme:
“Dr. KSS program to make Stock Gumshoe great again: Arbitrarily kick people out of Biopubkss”
From this forum:
“I can tell you from my perspective as someone whose PhD was in clotting biochemistry, I am sure AC5 will work in humans.”
A variation on JohnM’s great statement:
“It’s a shame that the man whose PHD was in clotting biochemistry and who found $ARTH as an investment and vetted the technology won’t benefit from what might be the biggest winner he ever recommended.”
ARTH Market Cap today $66.319
Capital raised by ARTH since its inception $ 32.594 million
Cleveland Ratio 2.03 (66.319 / 32.594)
FOR EVERY DOLLAR RAISED BY $ARTH ($1.00) it is worth $ 2.13 (for $CLRB for every $ 1.00 raised it is worth $ .18 today)
I will be going into the Cleveland Ratio. Note that I did a very poor job of teaching Dr. KSS so I have to improve.
CohBar CWBR
Understand that they spent approximately $ 50 million of grant money before becoming public.
CWBR Market cap today $ 198 million
Capital raised by CWBR since its inception $ 34.2 million
Cleveland Ratio 5.56 (198 / 34.2)
For every dollar raised by CWBR ($1.00) it is worth $ 5.56—- WOW
CWBR is just getting started.
My impression is that many folks are focused on the expense side of the equation: If $ARTH (or any clinical-stage biotech) spends money, it will bring the ratio down. Lengthy trials cost boatloads of money. Therefore, the Cleveland ratio is meaningless for companies involved in complicated research.
This confuses (what I think is) your point.
What your ratio does is compare money spent to how the market values those expenditures and efforts. In that way it is very clever.
Here is an analogy. My neighbor (who is a total jerk and preoccupied on his image, but I digress) buys a $75,000 car (actually, he just leases so he can upgrade every three years and massage his ego, but for the moment let’s assume he buys the Mercedes this one time). I spend $75,000 on a painting. Three years later, my neighbor’s car is worth $50,000, while my paining is appraised for $100,000. Who spent their money wisely?
His Cleveland Ratio is 0.67, while mine is 1.33.
We spent the same amount of money. Neither one of us have funds left–he has a (devaluing) car, while I have an (appreciating) painting, but the market values my purchase higher.
That, I believe, is your point, and it is an interesting one.
My only comment to that is that often it takes years for results from clinical trials, so the Cleveland Ratio for some of these companies may wallow at less than 1.00 for years until experiencing a sudden spike. So to me, it would have most meaning as measured after a cusp event, such as Phase Two results.
How’d I do?
STM I am working on several projects and will get back to this. My computer screens focus on this now. Thanks.
$DMCAF STROKE DiaMedica Therapeutics
Like $ARTH I believe $DMCAF is a derisked situation that I believe there could be a early exit by selling the company to Big Pharma.
I had a couple conference calls with Doc and management. Management is excellent. See my capital analysis. Company intends to do reverse split during 2018 but I believe they will time it with some positive news events. It trades tightly.
See the Capital analysis and other reports.
Cleveland Capital Analysis
https://www.dropbox.com/s/cerrnteddcs8fid/Capital.xlsx?dl=0
Zacks Initiation Report
https://www.dropbox.com/s/tbn3jej5luof0me/DiaMedica%20Initiation%20Report%20Zacksvery.docx?dl=0
Patrick Cox Email DMCAF—John Mauldin Investor
https://www.dropbox.com/s/fsq7ezofqcffeqk/Full%20Patrick%20Cox%20Article%20t.docx?dl=0
Sale of Competitor Product establishing Value for DMCAF
https://www.dropbox.com/s/rm45kswle46q9th/DMA%20Sale%20of.docx?dl=0
Actual Zacks Initiation Report https://www.dropbox.com/s/qnq325artcnpswu/V.DMA_Initiation.pdf?dl=0
About DiaMedica Therapeutics:
DiaMedica Therapeutics is a clinical stage biopharmaceutical company focused on developing novel treatments for neurological and kidney diseases. DiaMedica’s lead product candidate DM199, a recombinant (synthetic) form of the KLK1 protein, is in clinical development for the treatment of acute ischemic stroke and chronic kidney diseases.
DiaMedica’s shares are listed on the TSX Venture Exchange under the trading symbol ”DMA” and on the OTCQB under the trading symbol ”DMCAF.” For more information, please visit www.diamedica.com
“The compound is used in Asia for an astonishing list of diseases, despite the fact that it’s extremely expensive. The Asian form is also suboptimal as a Western drug candidate because it comes from pig pancreases and the urine of young humans. Using animal or urine sources is not just aesthetically distasteful, it introduces risks of contamination into the production process that tend to put off regulators.
DiaMedica solved that problem by developing a proprietary, genetically modified cell type that expresses enormous amounts of KLK1 at a fraction of the cost of existing cell technologies. Big Pharma had tried to do this for years, always failing.
These cells have allowed DiaMedica to synthesize a drug under standardized conditions that has enormous potential—not only as treatments for many diseases, but as a breakthrough anti-aging geroprotector”
Diamedica Analyst Reports (background information)
“Worldwide, 1 in 6 people will experience a stroke in their lifetime. There are approximately 17 million strokes annually worldwide (2 million in China) and approximately 6 million lives lost each year to stroke. 87% of these strokes are termed ischemic strokes, a blockage rather than a hemorrhage (bleeding into the brain) and thus appropriate for kallikrein-1 therapy. Tissue plasminogen activator (tPA) is the only U.S. Food & Drug Administration (FDA) approved treatment for ischemic strokes; however it must be administered within 3 hours (and up to 4.5 hours in certain eligible patients) of a stroke. This vastly limits the number of people that can receive treatment because of the logistics of getting the people to the hospital and evaluated in time. Kallikrein-1 therapy can be given up to 48 hours after symptoms start, making it possible to treat a very large number of appropriate stroke patients.”
Diamedica Analyst Reports (background information)
Zachs Initiation Report on Diamedica Feb 2017
http://s1.q4cdn.com/460208960/files/News/2017/V.DMA_Initiation.pdf
Zachs Small Cap Research Report –dated but worth reading Sept 2017
http://s1.q4cdn.com/460208960/files/News/2017/Sep-12-2017_V.DMA_Zeng.pdf
Zachs Small Cap Research Report –dated but worth reading Nov 2017
http://s1.q4cdn.com/460208960/files/News/2017/Nov-28-2017_V.DMA_Zeng.pdf
Zacks Small Cap Research Report March 2018
http://s1.q4cdn.com/460208960/files/News/2018/Mar222018_V.DMA_Zeng.pdf
March 2018 report:
http://s1.q4cdn.com/460208960/files/News/2018/Mar222018_V.DMA_Zeng.pdf
All Biotech investments are extremely high risk. This is not a recommendation for investment. Cleveland does not care whether you own or not.
$DMCAF Here are come changes. Most important is the Cleveland Capital Analysis. which was update to 3/31/18—-
Capital —Note upside potential
https://www.dropbox.com/s/jyr9r6x0g9nd9gu/DIAMEDICA%20GOOD%20Capital%203%2031%202018-%20Copy.xlsx?dl=0
Sale–Techpool Bio-pharma sale and impact on DMCAF
https://www.dropbox.com/s/pr599ei459syb9o/DMCAF%20Sale%20of.docx?dl=0
$DMCAF, wow, Cleveland, great stuff! There goes my weekend…DD time.
JohnM
This is right up your alley for picks. IMHO there will be early exit by Big Pharma buyout. How soon? CEO Rick Pauls is the person to talk with.
John Mauldin in the deal does not hurt !
Sigh, you and Doc did make a good team
Agree. But lying and slandering me is plain WRONG. All to improve your own self image?
“Ardelyx once interested me, but Cleveland saved our collective backside as the quants were unsound.”
“I think it’s horrifying Cleveland got caught in the crossfire on this one and called a liar. Cleveland is a man of extreme integrity and insight who is here to shine light on situations, and he is indispensable.”
“Cleveland’s posts are of great moment, valuable to all, and I’d prefer to see them in the forum.”
Eyedoc
“I want to thank Cleveland for contributing to a life-altering change in the way I think of companies that I invest in. There is NO WHERE that you can learn what Cleveland is teaching you, except to be a financial insider on Wall Street. You all know this if you read his posts. There is nowhere that someone treats you like a son on the internet when finances are involved. The financial media tries to keep you frightened. This effectively makes you do things that you should not do at the precise time that you should not do it.
Cleveland has us staring to think like an insider.
Clevelands posts have affectted me like no other has in the last 20 years.
With Cleveland and Doc trying to steer us away from unintebded financial bad moves, we are miles in fron of the Main Street financial shock troops and way closer to being able to retire than we thought we would be.”
Well Cleveland, sh*t hits the fan so fertilizer can rain. Your comments are helping to make things grow . Much appreciated
$ARTH Arch Therapeutics CEO looks ahead to positive results on AC5 gel
http://tinyurl.com/ydco3az3
“It’s a shame that the man whose PHD was in clotting biochemistry and who found $ARTH as an investment and vetted the technology won’t benefit from what might be the biggest winner he ever recommended.”
$CLRBZ
Cleveland, good to see you posting again. I’m wondering if your thinking has changed about CLRBZ warrants. You made a compelling case for them in the past, though they’re worth little now. Cellectar says they’re funded into 2019 Q1, but the last 10Q did not sound confident about raising funds necessary to continue beyond that time. Is this company about to go belly up? I have a basket of Z warrants and am wondering whether to salvage what I can…
$ARTH long and certainly enjoying today’s improving stock price…
v/r
jdd
Yes… Quite nice. Certainly won’t go up like this every day…. but it was definitely under valued. The Good Times are starting to Roll.
$ARTH long
Amen, jdd.
Sure glad I had faith (although I’m normally not very religious). Been buying $ARTH all the way down – even got some at 26cents. Maybe too soon to buy champagne but it sure feels good.
Today’s announcement doesn’t look good for us $ARTH shareholders. Appears today’s announcement selling another 9M shares at .50 will be dilutive to our current holdings. Positive PR… company sells new shares into the bump… current shareholders get the dilutive shaft… rinse/repeat.
https://ir.archtherapeutics.com/press-releases/detail/509
$ARTH – “today announced the pricing of registered direct offering of 9.1 million units, each unit consisting of a share of the Company’s common stock, and a Series G Warrant (“Series G Warrant”) to purchase 0.75 of a share of our common stock for the combined purchase price of $0.50 per unit. The Series G Warrants have an exercise price of $0.70 per share and are exercisable for a period of five years.
The gross proceeds to Arch from this offering are approximately $4.5 million before deducting estimated offering expenses payable by the Company. The offering is expected to close on or about July 2, 2018, subject to customary closing conditions.”
Well, they got the influx of cash they need to ride out the next few quarters
Possible re-entry at .27?
Pure speculation, but I highly doubt it will dip that low. Gut reaction is that it will ride around the .45 mark here for a while until an update on the study comes out.
Hopefully you’re right but if we see a close below .46, there’s some support at .36 albeit weak. I still believe we could see a touch of the longer-term support in the .26 to .27 range over the next 6-8 weeks – then a nice ramp if they don’t have to go back to the well before October. If, on the other hand, support holds at .47 and we close with volume, could be a nice low risk entry.
$ARTH long What do you mean by “if they don’t have to go back to the well before October”?
John,
Do you have any thoughts on what occurred yesterday?
Thx- Joe
I worry a lot more about biotech companies that can’t raise money than those that can. This $4.5 million will carry ARTH into the December 2019 quarter, so we will get the results of the sensitization study, the 510(k) filing, the CE Mark filing, the 510(k) approval, the CE Mark approval, and the IND filing for internal use before he needs to raise money again. Actually, I expect him to sign a distribution deal in 2019, if only for Europe, that should provide enough upfront cash to avoid any more stock sales.
Norchi has an MBA and ran Putnam’s healthcare fund for four years. I don’t think he is naive about how the stock market works. These deals usually are priced at the average of the last 10 days closing prices.
https://finance.yahoo.com/quote/ARTH/history?p=ARTH
Maybe the stock would have held yesterday’s 66-cent close, or maybe not. If Norchi could have raised money later this summer (when it is harder to do a deal) at 60 cents, he could have gotten the same amount of money for 1.5 million fewer units. That’s not a big deal. But if the market tanked he might have had to raise it at 40 cents or not at all. That would be a VERY big deal.
Development-stage companies are told to raise money when they can, not when they have to. If Norchi keeps putting out press releases on the progress of the sensitization study, as I urged him to do a few weeks ago, I think we’ll be back in the mid-60¢ area pretty quickly.
If the current raise is enough to carry them through until their next FDA submission.
Do you mean the October 2018 submission? Norchi only burns $1.3 million a quarter and said before the raise that he had enough money to get into the December quarter. He now has enough to get through the September 2019 quarter. Why on earth would he have to “go back to the well” so soon after doing a large capital raise?
Thanks for your insight John – invaluable perspective and I can tell BioPharma is your ballpark. I’m learning much reading through your well appreciated thesis. I missed that they raised enough to carry into the Dec QTR – thanks!
Many herein see technical analysis synonymous with the reading of tea leaves but I believe that psychological and Algo buy/sell points are entwined with price action/momentum for higher probability market direction.
I’m overall bullish $ARTH, but believe we’re do for a pullback to prior support at .37 and possibly .27 respectively if we don’t see a break soon through the strong resistance and proof of support at the .50 level.
Best Regards,
Mike
Nerve damage caused by traumatic injury could better heal with hydrogel that is 15 times stronger than currently available wound sealants. https://news.northeastern.edu/2018/06/27/hydrogel-could-regenerate-stronger-healthier-nerves-in-injured-soldiers/? TY https://news.northeastern.edu/wp-content/uploads/2018/06/koppes_1400 .jpg
Photocrosslinkable Gelatin/Tropoelastin Hydrogel Adhesives for Peripheral Nerve Repair
Soucy Jonathan R. , Shirzaei Sani Ehsan , Portillo Lara Roberto , Diaz David , Dias Felipe , Weiss Anthony S. , Koppes Abigail N. , Koppes Ryan A. , and Annabi Nasim #MeTro 🙂
Published Online:9 May 2018 https://doi.org/10.1089/ten.tea.2017.0502
$FYI – Supermarket Meat Still Superbugged, Federal Data Show
https://www.ewg.org/research/superbugs/
Some could read this as data can be interpreted as you like, other may go vegan, I’ll continue to be sure my food is cooked.
Griffin, thanks for the information. This report could possibly be true, however EWG (Environment Working Group) has a strong connection to pseudo-science, so I am usually skeptical about the studies they provide until I can do further research.
If it is true, then we should all be very very worried.
Regards,
Rich
In fact, an article in Forbes magazine states “In reality, the EWG, which has been dubbed the Environmental Worry Group, frightens consumers about chemicals and their safety, cloaking fear mongering in a clever disguise of caring and empowerment.”
I agree with your first comment completely. Forbes I’m not familiar with judging that they are a financial mag and the language within the quote I’d say they are bias to the right. The article I posted came from Mother Jones and they are bias left but they do follow Journalism ethics. How well they may of vetted the article I’m not sure. Thanks for posting.
Yes there is a lot of bias in digital media. The important thing is to remain diligent, so thanks again for the information
Vigulant not diligent, or maybe diligently vigilant. Have a good day
Tetracycline was used as a feed additive for decades before it was known that
resistant bacteria were developing.
Now use of anti bacterials are used to treat disease under strict restrictions.
Poultry is often contaminated with salmonella and should be cooked thoroughly. Any ground meat also needs cooking as surface contamination may be mixed throughout. That includes weiners.
Pork should be cooked medium well or more.
Other meat as whole cuts, steaks, roasts etc need surface cooked but should be safe to eat with rare interior.
All meats could be made entirely safe if exposed briefly to penetrating radiation during processing and packaging like the boxes of broth that are so done. That does not make the meat radioactive like the envirocrazies who fought so hard against Irradiation shouted. Does not affect the food any more than microwaves or heat radiation does.
$ARTH – lp
Arch Therapeutics Announces Poster Presentation at the 2018 Military Health System Research Symposium on Tuesday, August 21, 2018
Download PDF
Early stage ophthalmology and anti-inflammation pipeline projects highlighted
https://ir.archtherapeutics.com/press-releases/detail/511
$ARTH atlas long
way to go Arch! long time since latest concrete and good news 🙂 an infection is much more common cause of overload to healthcare, patients and their loved ones, welfare systems etc than abrupt bleeding – even if not so deadly at first. this is bound to be a big thing in future.
i just wonder why they decided to start with ophthalmology? easiest access? most cost effective? certainly not the easiest part of body to treat for sure.
nevertheless, i’m happy things proceed and CEO gave some sneak peek to future too. still holding my fingers crossed.
yours, Finn
Enough time has passed to ask a question.
Since following was posted beginning a major change.
https://www.stockgumshoe.com/2018/02/microblog-an-open-letter-to-doctor-kss/
Is your life & overall happiness better now than before?
Investments all rosy?
Best wishes to all
shall we keep this thread dedicated to $ARTH and continue talking of KSS in thread provided by Arch1?
yours, Finn
Yes. Please.
And thank you Arch1 for providing the link to Hipockets’ Open Letter. Sometimes I think I live in an alternative universe because I did not even know that such link had existed.
I just read it all. I’m glad we are past those days.
$ARTH atlas long
https://ir.archtherapeutics.com/press-releases/detail/513
“Study finds no evidence of irritation or allergic reaction in any enrolled subject”
yours, Finn
Giddy Up! Attempted to post at 7:55 but been in moderation for some reason. Have to wonder who the buyers were yesterday just before news???? Seems a bit leaky.
And with this supposedly good news, the SP drops 2.5 pennies today. I am rapidly losing faith in this company.
I think letting changes in the stock price affect your faith in the company is a mistake, up or down. Norchi’s presentation was excellent and the new slides in the presentation added valuable insight.
$ARTH
Agree. I could talk for days on that presentation.
Let the numbers speak.
ARTH capital raised since inception $ 29,978,723
ARTH capital spent since inception $ 23,489,622
ARTH Cash 6/30/18 $ 6,489,101
Cash % of amount spent since inception 28 %
ARTH Warrants outstanding. 25,583,139
Amount of cash if exercised $ 13,045,084 or $.51 share
This cash % of amount spent since inception 55%
Closure Medical acquired by JNJ 2005 $ 370 million
% Arch Market Cap to Closure Acquisition Market Cap 21.54%
ARTH Market Cap $ 79,714,833
Cleveland Ratio ($ 79,714,833/ $ 29,978,723) 2.65
For every $ 1 ARTH has raised it is now worth $ 2.65
In my opinion ARTH will not have to raise another penny relying solely on warrant exercise.
With around 50 patents ARTH patents we are going to see numerous new product roll outs. ARTH’s intellectual property strategy was a complete knock out of competition.
Dr. Norchi Presenation
http://wsw.com/webcast/rrshq28/arth/index.aspx
Thank you Cleveland the numbers bespeak your experience.
Considering what has transpired with this stock with this since the close of the phase 2 trial closed I’m not surprised the SP hasn’t moved, and what it has gone down I think we attribute to the faint of heart. I don’t think we will see the SP move till the FDA gives it approval to go to market. Then we may not see a move to the full potential for this stock. It may take a couple of financial reports. If I wasn’t already OW on this stock I would be buying more.
btw IIRC we were thinking $3-5 on SP.
$ARTH long
Cleveland: Assuming $ARTH gets thru 3rd trial and FDA approval, can you share your thoughts on their go-to-market strategy? Do they have a marketing/sales pipelune in place or will this be a new process for their team?
Not Cleveland, but the Irish trial was not a Phase 2 trial. It was the only trial required for external use registration in both the US and Europe. Norchi has said he will file for 510(k) approval by the end of September and EMA approval in the December quarter. A while ago he implied they were expecting a quick 2- to 4-month approval, but he hasn’t repeated that lately.
The next trial is the only trial required for internal use registration in both the US and Europe.
Norchi has no marketing/sales pipeline in place and I doubt he will. The market for external use is so large with so many customers that he needs to sign a distribution deal or be acquired., IMO. I’m at $10-$12. Very long.
So, on approval, should we expect a sell the news scenario until prospective buyers enter stage left?
Depends on whether it runs up in advance of approval by short-term traders. That often happens in biotech.
Hey Cleveland. For some reason I can’t login to SA. So lost contact. Agree. This is good news. Actually. GREAT news. A lot of their products are exterior and the fact this study came out well can only help the rest. Anyway Cleveland. Send me a mail at blackngold63@hotmail.com . Want to get back in touch. And regardless of the stock price today – well with this positive human study under their belt – well I think there is good reason to be optimistic.
$ARTH share price
Don’t be too disheartened Dr. B.; you’ve stuck it out this far.
Actually, if you look at the prices (per Schwab) for the previous days, you’ll see that the price was more around 40c -42c, hovering around 44c yesterday then spiking last night/this morning to 48.5c, and dropping back to 43c. So we’re actually up a cent overall.
It’s not the SP that disheartens me so much as the lack of any progress on this company’s part. Their bungling of basic processes over the years is enough (for me at least) to cause anyone to lose confidence. The bottom line is that this simply shouldn’t be taking so long! They have an amazing product that if all they say is true, could change the world of surgery, diabetic wound care, burns, trauma care in the streets and on the battlefield….. on and on. Why then have they been nearly incompetent in getting it to market? Forget for a minute that I am an investor. Assume that I speak as a physician/surgeon and that I am looking out for my patients and my family and friends, all of who could potentially benefit from this product.
I just watched Norchi’s presentation (as I have all his others). Why DOESN’T he run the videos of how miraculously AC5 stops bleeding? If I wanted the world to see what my product does and I wanted them to buy shares in my company, I would be playing those videos on giant IMAX screens! I would post them all on every media platform. If this product ever does make it to market, I sure hope he gets better at MARKETING.
I am very overweight ARTH and don’t plan on bailing out unless something catastrophic occurs, but I’m not getting any younger (as an investor OR a surgeon) . It’s just incredibly frustrating to see this supposedly game/life changing product languishing in biotech limbo for the past 4-5 years.
End rant……GOOOOOOOOZZZZE FRAAAAAA BAAAAH.
Ultimately it is a small bio-tech/pharma company. And while Norchi and the crew has talents on many levels – well the one thing they don’t have experience in is starting up a company from the ground level and turning it into the “Midas Touch”. It doesn’t happen often. But Norchi has kept the budget to reasonable means. The dilutions have not been outrageous unlike other start-ups. Mistakes have been made. That is to be expected. But obviously a good sign someone was confident enough to dump in 4+ million recently. And obviously a very good sign there was finally a human study done that showed no side effects. Looking back – well it should have been done 1-2 years ago. But again…..Money. But now it has been done – and it will go a long way to easing the path to approval for many other products. Which is not to say other trials/studies won’t be needed. Of course they will. But this is huge. The product works – and trials have been done with human subjects when it was applied to open wounds. And no side effects. Slow and steady – but I think we are finally back on track.
I wish I had your patience BnG. I understand mistakes can and will be made, but the ones ARTH has been guilty of, seem to be the most basic rookie mistakes. As far as having no experience starting up a company from scratch, isn’t that why they have who they have on their board? The Dhillons (I thought) were their “experience”. And we DID have a human study already. Remember the study with 46 patients 10 on anticoagulant therapy from a year or more ago? Why didn’t they tune that study to meet the needs of the FDA then?
Again, It just shouldn’t be taking this long. This is stated as an impatient investor with some good old selfish greed and as a selfless doctor who sees how this product could change surgery and wants what’s best for his patients.
Finally, I’m sorry. I missed the $4 million investment you mentioned. Where was that?
DB As a doctor/surgeon/shareholder why not call Dr. Norchi directly and ask questions? I know he would love to talk with you. You can give perspective that none of us can.
You are the kind of shareholder ARTH would love to attract. Dhillon was there solely to assist in capital raising and was very important early on in formation stage. Dr. Norchi raised the $ 4 million in less than 24 hours.
Please check back in here after you call. Thank You. Call
617-431-2313
Agreed. Team A brings the solution to FDA approval, TeamB comes in ‘after’ approval to minimize cash burn… e.g. after TeamA T’s the ball. Anything can and will cause delays. Can’t enter full-on Marketing/Sales mode before FDA approval. Typical to see delays till the channel(s) are established – can’t put the cart before the horse. We’ve come this far. Buy and/or add on the prospective dip after approval.
$ARTH NP. I was in for a while and then out when I realized I needed to gain my bearings in biotech or at least hone in on my risk tolerances. I am comfortable with my position sizing now and looking to possibly re-enter ARTH. My only issue is trying to figure out what the timeline is with this one. Reading through the comments it seems some have been waiting for 4-5 and there is not really a go to market strategy in place. I did just watch the latest slideshow presentation and still like the product and science, but for the life of me I can’t tell what the timeline looks like. Based on cash and burn rate they have 4 months before they need to start using new funding which means a raise would have to happen sooner than that. Does anyone have information on plans for future cash raise or plan for commercialization? Would like to re-enter but don’t want to sit for several years if I could use the capital elsewhere.
Thanks!
$ARTH – Arch Therapeutics to Provide Corporate Update at the Ladenburg Thalmann 2018 Healthcare Conference on Tuesday, October 2, 2018
https://ir.archtherapeutics.com/press-releases/detail/514/arch-therapeutics-to-provide-corporate-update-at-the
Will there be announcement that FDA 510k has been made?
ARTH long
If 510K is submitted soon, hopefully already has been. Does the 90 day FDA clock start again or should it be quicker? Really wish this company gets moving. They should be lining up marketing for the next step now. Hope the next step doesn’t take forever to line up, they just don’t seem to have any urgency is any thing they do. Don’t these patents run out sooner or later. Cleveland you have suggested calling Terri, would he really take a call from the street. I would like to offer my services to videotape AC5 in action for free. My son works for the head of surgery for the biggest hospital in St. Louis and I would like to introduce the two. My company shoots 8K hi-res video that I think could be used to promote AC5. Good video of it in action should sell itself. Cleveland could you help me get an intro? After vetting me first of course.
Yelpik I suggested drbonz call Dr. Norchi directly. We have not heard back.
Most of the 50 or so patents are new within the last three years. The oldest patents are irrelevant because of the significant R&D strides made by $ARTH.
Suggest you contact the gatekeeper of ARTH CFO Rick Davis and discuss your son and the head of surgery talking with Dr. Norchi and what you propose. Rick is easy to talk to.
Richard Davis
Chief Financial Officer
Arch Therapeutics, Inc.
Phone: 617-431-2308
Email: rdavis@archtherapeutics.com
Website: http://www.archtherapeutics.com
Hi Cleveland,
Do you think 510k will be (hopefully) approved closer to 90 days as application was already submitted once and they’ve had discussions with FDA concerning AC5?
Also, maybe wishful thinking, but don’t you think partner deal will come soon after approval, as they’ve been preparing for this for at least a couple years now?
Like Dr Bonz, wondering why stock price has been stagnant.
Best
Tim
$ARTH – Arch Therapeutics Announces 510(k) Submission to the U.S. FDA for AC5™ Topical Gel
https://ir.archtherapeutics.com/press-releases/detail/515
I’m hoping this is weeks away and not months. Chief Executive Officer, Terrence W. Norchi, MD, is scheduled to provide a corporate update on Tuesday, October 2 at 4:00 PM ET in Track 3 – St. Germain II.
ARTH long
Norchi once said two to four months, but he has not repeated that recently.
I think we need to listen to his presentation tomorrow for an updated to that. We have been here already what more does the FDA need to do, get the original 510K data out of the filing, review the data, and see if the sensitivity trial answers their questions. IMO it should be a slam dunk unless there was something from the first 510K we weren’t told. The FDA should be smart enough to know what AC5 means for at least EMS. Apologies for a little rant.
I believe that the FDA has 90 calendar days from the submission date of the 510K to respond. So that means we should hear back before the end of the year. Having become very pessimistic about both ARTH’s capability to execute and the fact that the FDA is a government agency, I would guess it will be on day 90 that we hear anything. Come on FDA, prove me wrong!
You are correct the FDA has up to 90 days to respond. Arch Therapeutics now has a person on board to deal with submissions to the FDA. I don’t remember what their credentials are but hopefully they have some experience in these matters. An inquiry t0 IR citing that person an asking for an informed guess might get more information, but I would not do that till after todays presentation. We have been here before and I see no reason that this should take 90 days.
$ARTH long
Missed yesterdays webcast. Anyone watch it? Any new news? I’m guessing not since no one posted sooner and since arth is down to .39 I’m assuming those investors didn’t run out and buy a bunch after the presentation.
It was one of Norchi’s best presentations ever. The moderating analyst let him run over and asked several key questions. It’s well worth listening to.