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It took me 4 days to discover that everyone has turned to this thread to discuss ARTH’s past and future. But in that 4 days of comments I see none concerning whether by withdrawing the 501k application ARTH has failed to meet the terms of the patent license from MIT. If ARTH in breach of the license contract then MIT has the option to waive the breach or declare it and sell the license elsewhere. This issue could certainly explain TN’s inappropriate reaction to the Ron Oliver call. All this contemplation of TN’s action could be moot unless we have an answer to the breach question. I have not been able to find the answer. Do we have such an answer?
Not sure, but I do remember people speculating here a month ago that it might not be a huge issue because the most relevant and up to date patents have been developed since the agreement and might not be covered by it. Whether that is true or not, well don’t know.
LazrryC., Norchi had to file for approval by a certain date and he did that.
LarryC: ARTH, I do not think Dr. Norchi and his team would be so careless after all this work(years) to lose the license, just for withdrawing the submission of AC5 for 510(K).
ARTH: Received a reply from ARCH(Rick Davis) that the MIT licenses are in full effect.
2/4/2018 From Twitter:
KSS, MD, PhD
@KSSMDPhD
22h22 hours ago
“ToddBA of Stock Gumshoe, one of my vocal detractors, is a lurid redneck and warty toad. So long, #shitforbrains. Then posted a George Carlin video “blow it out your a**”
It has been removed by Twitter as I reported it as vindictive.
But I did save a screen-shot of it.
Before you part with any more donations or join his new website, I think you should be aware that KSS has a troubled past and when he gets angry, really loses it, as evidenced by the uncalled for public rants against Norchi, Travis, and now ToddBA: this article by an ex-Gummie, Vivian Lewis gives quite a lot of information:
http://www.talkmarkets.com/content/news/special-report-benitec-biopharma-ltd?post=53286
Make sure you read the comment by our own Alan Harris at the conclusion of the article. I don’t think Alan feels the same way now. Alan left the night Dr. KSS threatened to sue him, then took down the entire 4000+ comment Arch thread along with his threat to make Alan’s life miserable.
As far as my revealing his true name, I would like to but am fearful of his retaliation, as was the case with Vivian not being willing to. I know his name, because he inadvertently posted it himself on 4/1/17 when he linked to an article on Medscape, not realizing he was still signed in.
This has been all too unpleasant and expensive for me, because I believed in him and the incredible estimates he gave of the multi-bagger potential of many stocks that were duds. It is true he is a great writer and has picked some winners as well. But didn’t he just tell us PTI could be a 5 bagger in the next month, only for it to fall 50% within days? I am leaving SG, and KSS for good. Best to all of you. Ron
Thank you Ron. Your entries have been very informative and well written.
Hi Ron,
I did see this on KSS’s Twitter. Didn’t find it worth responding to. I actually feel pity for KSS and hope he can find some inner peace.
I would ask you, Ron not to leave SG. Your input is very wise and would be sorely missed.
Cheers – Todd
I agree, and hope both of you to remain, Ron and Todd. We who are the spurned, insulted, and villified.
Thanks STM! Would be nice to see Alan Harris return to the forum.
Cheers – Todd
Ron you add value to our discussions, please reconsider leaving and remain posting.
Dermatologic Surgery Publishes Clinical Data on Arch Therapeutics’ AC5™ in a Topical Application https://ir.archtherapeutics.com/press-releases/detail/502
Good morning.
$ARTH. I think that the press release from ARTH is a rehash of what they have previously stated. In a Form 8K that the company filed today wherein they ‘officially’ released this press release, they stated “The results of the Study were previously reported in summary form in a press release issued by the Company on August 15, 2016, which can be accessed at the following address: https://ir.archtherapeutics.com/press-releases/detail/477/arch-therapeutics-reports-ac5-topicalhemostatic-device.”
I believe that the company is going into damage control in reaction to the recent collapse of its stock price. I would expect more press releases in the near future as well. But we need to separate the old from the new as we decipher these releases.
Long and OW $ARTH
$ARTH Nice to see you commenting KennyG
Penny
So, per ARCH’s site, the fact that they issued this release as an update with today’s date, was really a re-ignition of the old (e.g. nothing new)? And, might anyone know if TN is still a majority investor in the company(e.g. over $3M invested), or were these shares given to him for in-kind?
Norchi owns 15.5 million shares or 10% of the company.
KennyG, the “new” is in the published article, not in the press release telling us the article is published.
Great find Ben
$ARTH Will this be the missing info so they can file the 501K?
ARTH:Topline results of the study were previously reported in a press release issued by the Company on August 15, 2016, which can be accessed at the company’s website.
Dr. Norchi further commented, “We continue to develop our exciting technology for wound care and surgical applications. As our priority, we are committed to continued collaboration with the FDA and plan to submit a new 510(k) notice for AC5 Topical Gel as soon as possible following further discussion with the agency. We will provide a more detailed update when the plan is finalized
I’m not sure whether and how I should contribute to this discussion, so please bear with me.
First, I have been and remain a full supporter of Travis. I’ve never belonged to a stock service before, and probably never will again, but I have been a member of Stock Gumshoe for years simply because i support what Travis is doing to educate novice investors about newsletters pumping stocks which are often silly ideas. Travis, in my view, provides an incredible service and deserves support.
I never intended to follow Dr. KSS to another forum. My heart goes out to those who sent him donations and now feel cheated.
I don’t think it’s appropriate to “out” Dr. KSS, anymore than it is appropriate to reveal the identity of any of the rest of us here. If you want to learn more about him, all the information is publicly available to anyone who wants to sleuth around. If you know what KSS stands for and are a semi-competent dyslexic, you should figure it out fairly quickly, helped by his “clues” of where he has worked and where he went to school.
Based on that, I’ve known Dr. KSS’s identity for a long time, as well as his background. I believe that everyone deserves a chance to shine and felt that he had found a niche where he could be successful, but I underestimated the hold his quirks have on him, and for that I’m more disappointed in him than angry at myself. I don’t believe that he has intentionally misled anyone here, just that he is unable to fight off his demons, if you will allow me to use that word. Let’s give him credit–he does a great job at identifying those companies that are engaging in poor science, and eliminating the losers is a large step toward being successful in this space.
I do have a couple of comments:
First, after exhibiting a pattern of blaming others for their perceived insults and slights against him, does anyone really believe the accusations that he’s leveling at Travis? Huge props to you, Travis, for not responding, BTW.
Second, and related, does anyone REALLY believe his accusations about what his former best friend Dr. Norchi said to him? I would suggest that Dr. Norchi likely said something very diplomatic about how the company has to be careful not to divulge inside info, and he took it the wrong way.
Thirdly: OK. I was lambasted for outwardly stating that I thought it was premature to invest in Cohbar. I had a number of reasons, but one large one that I left unsaid was that I was terrified what could happen to a stock with such a tiny average daily volume, that had just experienced a massive run-up in the weeks before and hours after his announcement of “the greatest investment ever, a company that can cure all diseases and help everyone live to be 120.” Leaving aside how shady that tout sounds, I wondered what sort of damage he could do to the stock price if he suddenly changed his mind and got angry at their management like he eventually did Dr. Norchi. How much of ARTH’s market cap did he destroy in anger and vengeance against some perceived slight? Well, in my view, this would be much, much worse in the case of CohBar, if you consider the level of ownership among his followers.
This isn’t investment advice, of course; I not a doctor or scientist, and I have absolutely no idea what may happen over the next weeks or months, but if any of you are still in CohBar, please, please be careful . . .
z
Dittos to your balanced analysis, Save, and now I can say how sorry I was for your treatment when you had given what I thought was merely good advice, and which had been given often in the past without creating such a storm.
I don’t know if some are following KSS on twitter, but I have read his posts and see that he is quite determined to disabuse his followers of the idea that ARTH is a worthwhile investment, so I rather expect its price to be under pressure for a while if for no other reason than gummies were such a large part of its ownership.
Norchi is very careful with his spending and has a good product to which he has made improvements and has filed his own patents, so I think in the end this company will prevail. I also noted with interest that Dr KSS did leave open the idea that he might change his mind and reenter ARTH in the summer, so there is that. I plan to reenter, myself, as I have the funds to do it. Norchi has always moved slowly, so I don’t expect that to change and I expect to have to ‘hurry up and wait’.
My complaint with ARTH, independent of KSS or anyone else has always been the speed of execution. Too many mis-steps, which, given that this is their sole focus, is hard to digest.
There is a balance between conserving cash and advancing product development, and I believe TN has got that balance wrong. Nobody is in Arch to preserve their capital. There are treasuries for that (disregarding questions of inflation, fiat-money, etc). Unless Arch is going to get bought out at a fat premium for their patents, which I am sure they will not, those patents only matter when they get a product selling.
Still long Arch, but with vastly reduced expectations. It is becoming apparent to me that the opportunity cost of waiting for Arch to deliver their returns (and I submit that those will never be the N-bagger that might once have been hoped for) is mounting.
Well said,,, time is money or money has a time value + or-
I agree, Jabberwocky. I’ve been considering exiting ARTH for several months, but delayed too long, in part due to some personal stuff that was taking all my attention and focus. I no longer consider ARTH a long-term hold and plan to sell sometime in the next few months. This being biotech, there’s so much volatility that I’m just going to wait until the next bump up, which will probably happen when they refile their FDA application.
Thank you, Sharon. 🙂
STM, Dr. KSS did well by my portfolio and I feel that the significant contribution I made to his travel fund was owed and well repaid.
Thank you, Roger. Which is why my message read, ” . . . to those who sent him donations and now feel cheated.” I didn’t mean to imply that everyone deserves to feel cheated, just that I commiserate with those who are now angry and frustrated. I suspect you are not alone.
STM, Remember me? Looks like the Mayor and the Sheriff have left the town. LOL. Good to see your posts bud!
Hey mz! How are you?
STM It is good to see you back. Please keep posting.
Thanks, Frank. Good to interact with you again.
STM.. I stood up for you then and now. Something just didn’t pass the smell test with me about how you and a few others were treated. I am smart enough to know when a good poster is disparaged for no apparent reason. Honestly, I don’t understand why the anger, hurt feelings, and herd mentality over anyone’s post anyway? Really? Ignore works if you get upset… it is just a post isn’t it? On second thought maybe I’m not smart enough, or maybe It’s I don’t care enough to understand…
Good to have you back!
Following a bunch of reader requests over the weekend, I have set up a new page that you may use as a “home base” for biotech discussion if you like, and I sent out an email about Dr. KSS’s exit and letting folks know about the remaining biotech-related discussion areas (including this one).
That short biotech update is here, I hope you find it useful: https://www.stockgumshoe.com/2018/02/biotech-discussion-continued/
$no ticker. Travis. Thanks for the update and honorable way you have addressed Dr. KSS’s exit. Have a blessed day…
v/r
jdd
I rarely post, but I joined the site because I felt Travis did a great job sleuthing out all the newsletter hype. KSS blog was a bonus. I am an MD/MBA with over 25 years of experience investing in the markets. KSS behavior was just very unusual for an MD/PhD, as in not even-keeled. One minute he praises ARTH and Dr. Norchi, as the most noble, brilliant MD ever and the next minute he says “I warned you all that Norchi was lecturing to empty rooms at conferences”. It was a shock when he did that, based on some alleged slight on Dr. Norchi’s part. Then, he recently said that PTI was a 5x in a month, then after it crashes nary a word. Also, I was always very dubious of investing in someone’s ideas when they don’t have the conviction to reveal their name. Why the need for secrecy? I did sleuth out his name, and as someone else posted it was reveled he has serious anger issues. There are lots of ways to find ideas to invest in biotech as many good investors give ideas on Twitter all the time. Seeking Alpha has some good writers (Bret Jensen, Jon Faison in particular). I made more money by Bret Jensen’s picks this past year (OMER, DVAX) then I did on anything KSS mentioned. Bret’s picks were free also, though he does offer a premium service. The point being, don’t worship one individual. Do some due diligence, use biopharm catalyst, maybe look at what hedge funds are owning and go from there.
#OSUfballMD
Thanks for your comments, OSU.
Thanks also for mentioning Bret Jensen. Coincidentally, I was reading his latest SG article this afternoon and did decide to follow him on SG. I was also intending to ask around in the Gummune to see what Gummies might think of his research & ideas – and then you go & recommend him, thank you again.
Regards,
Penny
#OSUfballMD – SA Bret Jensen
Oops – apologies – Bret Jensen is SA contributor, not SG.
Apologetically, Penny
Just thinking,,,SA no longer anathema??? Seeking Alpha has some posters that are very good at what they do even with ignorance of Bio/Pharma.
The best technology is not always adopted,,, re BetaMax vs VHS. There are many other factors including timely market entry, eg $ARTH, production capability and marketing skills etc. Govt. policy/political decisions often affect success or failure, ie military contracts, Medicare approval etc. IMO
Seeking Alpha does have a lot of good contributors, article writers and forum participants. Of course there are people with ulterior motives, e.g. pump and dump, so be careful. I decided to invest in $IONS after a person in one of the forums there made a pretty good bull case for it relative to the CAR-T drugs, and this reader was an MD who was involved in the clinical trials for some of Ionis’ drugs. So there are MD’s posting there who have some good insights.
Oh, also forget to add. I don’t believe for a second that Travis was “jealous” and shut the site down. For someone to accuse Travis like that raised red-flags in my mind. Kudos to Travis for not getting in the mud with KSS.
I have said for a long time,,, Sanity is only a matter of degree.We all have bits of the irrational. Can that be overlooked or balanced by other things???
RE OSU,,, Buckeye, Beaver or Pistol Pete???
Go Bucks!
OSU Thank you. Reason I asked is those are three very different cultures and knowing helps me understand you better. 🙂
deleted
$ARTH SEC Filing Alert – SC 13G/A: Schedule filed to report acquisition of beneficial ownership of 5% or more of a class of equity securities by passive investors and certain institutions
https://s3.amazonaws.com/content.stockpr.com/sec/0001445866-18-000142/0001445866-18-000142.pdf
I was searching for Mike and Ana Parker from Arizona (Investors in ARTH) and found this story.
https://www.azcentral.com/story/news/local/karinabland/2016/12/25/how-giving-up-big-diamond-helped-kids-find-their-big-dreams/95691348/
$ARTH ow
For the Parkers wonderful charitable sakes (and we Gummy longs too!) I trust that $ARTH fulfills the promise of its science.
Penny
Wow. They sound like wonderful people. And we sure could use some positive JuJu for this stock.
I just realized that when I post, it is listing me as a “Guest” and not an “irregular”. My membership is on autopay as far as I know. Travis?
drbonz – just make sure you are logged in. If not, you will show us as guest…I know because it’s happened to me several times.
v/r
jdd
Thought I did but I must not have been. Now I seem to be back in the world of the Irregulars. Thanks!
$ARTH atlas OW
https://ir.archtherapeutics.com/press-releases/detail/503
Arch Therapeutics to Provide Corporate Update at the 30th Annual Roth Conference on March 12, 2018
let’s hope there’s something new and maybe we’ll hear more of 510(k), CE and others too.
With the new posts about ARTH from Cleveland two days ago on the main thread, nothing here concerning them on the ARTH thread?
Drbonz, if i understood you correctly:
i’m not sure if Cleveland actually posted anything we weren’t familiar with already, so probably nobody bothered to talk (or didn’t know what to add) here about things that have been repeated couple of times before.
very thorough post from Cleveland, as usual, and gave us once again a reminder why we decided (or decided not) to invest in $ARTH at the first place. there were also few undisclosed points too that now were served from a bit different perspective.
so if there was something in your mind, please feel free to post and we’ll talk 🙂
yours, Finn
$ARTH 10xow – Polyganics of the Netherlands has a surgical patch to stop bleeding. “It’s applied like duct-tape on a tube,” CEO Rudy Mareel told me about the sealant patch. The device is applied during the operation in tandem with a liver resection or other abdominal surgical procedures. https://labiotech.eu/polyganics-breakthrough-device-fda/.
This may not have the broad application that AC-5 has, but it’s competitive and ARCH failures have given them a head start.
$ARTH
Larry – thanks for the “heads up”. Very helpful post.
PetervR
$Arth
Agree. Not good news to have any competition out there. Much less one given a fast track FDA approval. Having said that….not sure it is in the same league as the Arch pipeline. But they need to finally leave the gate and get rolling.
$Arch Therapeutics Provides Update on 510(k)
GlobeNewswire•March 12, 2018
FRAMINGHAM, Mass., March 12, 2018 (GLOBE NEWSWIRE) — Arch Therapeutics, Inc. (ARTH) (“Arch” or the “Company”), developer of liquid, gel and solid hemostatic and wound care devices, today announced that it has utilized the Food and Drug Administration’s (FDA, “the agency”) pre-submission process to submit a proposed development strategy to the FDA to address the agency’s comments on its previous 510(k) submission for its AC5 Topical Gel product.
As previously reported, Arch voluntarily withdrew its 510(k) notification for its medical device AC5 Topical Gel from the FDA after receiving comments from the FDA late in the review process for which a complete response could not be provided within the FDA’s statutorily-mandated 90-day review period. We are proceeding with our disclosed intent to gain a better understanding of the agency’s comments and submit a new 510(k) as soon as possible, which would follow appropriate discussion, agreement and completion of a plan.
The 510(k) package previously submitted by Arch included a comprehensive battery of tests. The agency requested further evidence that the product does not cause sensitization in humans. While we respectfully disagree that further evidence should be necessary, we are working with the agency to address their outstanding comments, and we have determined that the most expeditious path involves providing additional data.
In order to provide a comprehensive response to the agency and minimize further delay, we consulted with several medical experts and developed a strategy to perform a small, three-month long, non-invasive human study to provide the additional data to the FDA. The Company has presented this proposal to the FDA via the pre-submission process with the intention of ensuring that the strategy will address their questions. Based on the body of scientific data that the Company has generated, including favorable results in a prior animal test for sensitization, we anticipate supportive findings in a human sensitization test.
Terrence Norchi, MD, President & Chief Executive Officer of Arch, commented, “We determined it most prudent to submit a pre-submission filing to provide the agency adequate time for full review of both the information we presented and our proposal. We expect this phase of the review process by the agency to last roughly two months, after which we would expect to initiate the proposed study at a cost of approximately $100,000.”
Assuming that the FDA agrees with the Company’s proposed development plan and the additional testing is completed when expected, Arch expects to submit the 510(k) later in the third quarter of 2018. Arch also expects to file a CE mark in Europe for AC5 in the second half of 2018.
Dr. Norchi added, “This puts us on target to submit the 510(k) later in the third calendar quarter of 2018 and for us to hear back by the end of 2018 with possible commercialization mid-2019. We believe that the additional testing will answer the agency’s questions and be helpful in future regulatory submissions.”
Arch remains focused on manufacturing scale-up, clinical regulatory strategy, developing commercial partnerships, advancing intellectual property and expanding its pipeline of products.
That hurts 🙁
I am still a huge believer. I do think it will pan out bigtime. But…I can understand why people have gotten frustrated.
I wouldn’t mind sitting on my 10,000 ARTH shares if I hadn’t already lost 4 grand while doing it.
I have brought up the fact that other people have patches already and this company is not the first. Doc and eyedoc said it is not the same. The liquid ac5 is better for certain types of bleeds. They thought ac5 was superior. Just FYI
Well, it’s nice to see that it seems like a relatively benign thing that needed to be addressed but it is a big disappointment that we’ll AGAIN have to wait another year or more for commercialization.
I also am disappointed about the delay. But I do believe in AC5. I’m more concerned that they will have to do another money raise now. I’m confused if this new FDA application is still only for topical applications or if this could be used internally. Any body else know? Cleveland??
The agency requested further evidence that the product does not cause sensitization in humans.
So the FDA is only looking for more evidence that it does not harm humans.
The new application is only for external use. But when AC5 is approved, surgeons can use it for internal use if they want to.
ARTH will have to do another capital raise, probably to all the same folks that have put up the money so far.
$Arch
Ran across this last week but got sidetracked and thought it might be relavent to our discussion. Allergan purchased a private Australian company, Elastagen, for $95M in February. You can read about this here, http://www.elastagen.com/#news. They have several products in development that will fit very well into their Aesthetic portfolio that currently dominates with products like Botox and Juvederm.
I also noticed that Elastagen also has also done significant research and development on another product, MeTro, which is a highly elastic protein based surgical sealant that would definitely compete with AC5. I can’t recall this product ever being discussed here but will provide a 2017 paper on it, http://www.elastagen.com/wp-content/uploads/annabi.pdf. In looking at it, there is significant data on it and I have to believe that this product could be a game changer….but never heard anything previously which I thought a bit strange based on all of the time we have put into Arch.
One of the big differences will be that it requires UV light for activating, but they can control the elasticity which would allow its use potentially on all tissues. I doubt that AC5 will have the strength this product has….but then again most of what Arch has provided us with is theoretical and a bare bones website to learn more about its potential. I have a fairly large position in Arch but really struggling with their molasses approach to moving this along. Just curious to what others might think after reading this. Still think AC5 has some significant potential….but think the MeTro product a threat as they have already done studies vs. other current leading products.
Bill
Not sure I am reading this correctly, but it appears MeTro is not clear and it takes 30-180 seconds. That would make AC5 still the winner.
AC5 will clearly control bleeding and allow surgeon a clearer field, no contest…but nothing out yet on how long and most likely will not have either the strength or elasticity that MeTro is showing on lungs, vessels and other structures inside the body where pressure control is also a factor.
Last thing a surgeon wants is to close an incision only to have bleeding occur days later and have to reopen. The increased time involved still shorter than suturing. I fully admit that these 2 products are apples and oranges…but still both fruits and better than current options. Just a little surprised that it wasn’t at least mentioned previously.
Interesting but not as advanced as AC5. If TN can get FDA agreement for the next phase of human trials, ARCH will be well ahead.
$ARTH – Please excuse me if I’m not in the right thread, plus this may be very old news, however, I’m going with the “better safe than sorry” excuse.
“Arch Therapeutics has filed a pre-submission with the FDA for feedback on its plan that will address FDA comments from its previous AC5 Topical Gel product 510(k) submission, according to a March 12 press release. Arch recently withdrew its 510(k) submission for its medical device after the FDA left comments in the late review process that the company could not completely respond to within the allotted 90-day period. The previous 510(k) that Arch Therapeutics submitted was a comprehensive battery of tests. The FDA requested that the company provide evidence that the topical gel did not cause sensitization in humans.”