Discussion page for Arch Therapeutics (ARTH)This page is for discussion of Arch Therapeutics (ARTH).
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Tick tock, tick tock.. The clock..
$arth np
Looks like some heartburn for shareholders today
ARTH
What takes so long for the FDA to respond to their NDA, they did submit one.
Frustrated as well.
$arth
on average it takes about 6 months. Its been 4.5 or so.
I have a question about the FDA 510k approval.
I see the following from the FDA website regarding device registration and ARTH is listed in their database now as per the link below.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=529643&lpcd=NAE
Initial Registration
Submit registration and /or listing information within 30 days of an establishment beginning an activity or putting a device into commercial distribution. Foreign establishments must register before exporting products to the United States and domestic importers must register before importing products. Reminder that if your device requires premarket notification clearance or approval, you will have to wait until your premarket submission [510(k), PMA, etc.] is cleared or approved to register your establishment and list the device.
Also product code NAE’s submission type is 510k (exempt) and is that the reason AC5 could be listed right now since it does not require premarket notification clearance or approval? Does being listed on their website mean that it is already approved? I am just wondering if we should be waiting for the approval or it is already approved. Also there was no comment from ARTH about the Missed MDUFA Decision Communication after 100 days from the submission date.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=5644
This was posted on the main discussion thread:
Author: watermaven
Comment:
$ARTH np. I recently said I would try to contact the FDA to see if the designation “510K-exempt” showing on Arch Therapeutics application was an error, as I believe Dr. Norchi said he thought it was “odd” or something to that effect, when the Gummies asked, and some Gummies said they did not understand it. In speaking with a project director in the department that is handling this application I could only get general information as they have to be very careful to not disclose details to anyone not affiliated with the company.
So here are the tidbits I was told or inferred: “The 510K-exempt” is not an error; it was the way the company did apply for the uses of AC5. He stated there could be a variety of reasons to do this, for example an intention to market to foreign countries or expand the uses beyond exempt. Exempt means the product is so safe, it does not need a 510k application. Some people thought that that an exemption had been granted already by the FDA to Arch from looking at the status page. This is not the case.
So I would have preferred Dr. Norchi to say: “these are the reasons we applied in that manner” rather than to brush the question off.
The gentleman I spoke with at the FDA Office of Drug Evaluation said a few other things that may be helpful to think about. If I do understand what I was told by the FDA, there are very few products in the NAE category that have been approved in recent years. The FDA sent me the following. Do I understand correctly that this is the description of what AC5 has to be very similar to to be approved? Do you think it is substantially similar?
Sec. 878.4022 Hydrogel wound dressing and burn dressing.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=878.4022
Here is one he sent me that was approved, albeit it was a revision to their product and this was in2009: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083721
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
If you put NAE in the search box, only one product comes up: ZENIEVA approved as substantially equivalent (SESE).
I would very much appreciate comments by those who are more familiar with the science of AC5 to comment on what I believe I have found to be a comparison device they need to be substantially similar to for approval as well as the description of the category 878.4022 which they need to meet for approval of their 510K. If it is true, as Dr. KSS points out that the approval for external use might not move the SP much, how do you think a denial might affect the share price. I would guess very adversely. If this has all been discussed previously I apologize if I am causing undue anxiety. Since the FDA contact I made is trying to help me be better informed, I wanted to share this information with all of you. I am not advising any action be taken in the buying or selling of shares of $ARTH based on my DD. Have a great weekend, all.
———————
Author: watermaven
Comment:
$ARTH np Since my talk with the FDA and the post I did yesterday, I thought I would continue my DD and want to share my findings with you. Having learned to navigate the FDA website to some extent I chose to consider some “what if” scenarios and here is what I found: Starting on the ARCH website, I took a look at one of the “existing treatments” products to determine how it was approved for use by the FDA. Knowing that they need to show substantive similarity to an existing product, I chose Surgicel as it is in the category of Polymer hydrogels. Surgicel was approved through a PMA not a 510K. Is is possible to compare AC5 to this product for a 510k approval. I would think not. I would think they would have to apply for a PMA. Then I took a look at what products had been approved by the FDA with a 510K that might be similar to AC5 but in a different category than the one they chose for their application (NAE). I noted yesterday the only comparison product in that category was Zenieva.
I found Gelspray Liquid Bandage which was approved with a 510K in 2008 in Section 880.5090 “Liquid Bandage” and product code KMF: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=5331 Although this category has no reference to the “control of bleeding” if you look more closely Gelspray is purported to control bleeding and has been approved: https://www.medgadget.com/2008/02/military_develops_gelspray_liquid_bandage.html
Disclosure: These comments are not meant to be critical of $ARTH or imply I have come to a conclusion that they will or will not have their 510K approved. I am learning for the first time about the FDA approval process for medical devices and this is all new to me, and I hope it is helpful to you. I should add that in the FDA self-performance review for 2017, in addition to stating their average # of days for 510K approval is about 125, they also state that this year 95% of submitted applications were approved within the 90 day guidelines they have set for themselves. Although one could be reassured by Dr. Norchi’s recent comments that they have been “in touch with the FDA” throughout this process and that they have not received an AI letter, I am concerned that investors could lose confidence as more time passes beyond the timelines I noted above.
——————–
Author: watermaven
Comment:
Hi rlamore–I’ve spent the last hour trying to find the chart I referenced, in the labyrinth of the FDA and have yet to find my way back. I will post again to you if I can find it. I do agree with your analysis that it could be a long time coming for approval if it hasn’t happened by now if my memory of the chart and the 95% approved in 90 days is correct. A few days ago, I did ask Kirin Smith IR at ARCH about their expectations and he said he had heard some approvals were taking 180 days. I am not sure if he is in the loop at $ARCH or simply there to reassure investors that “all is well.” But I wondered why he said what he said when I was thinking “within the next 30 days.” I was calling about the confusion about 501K exempt showing on the FDA website and thought to ask him if he thought approval was imminent.
—————————
$ARTH long
Does anyone else think $ARTH when you read this? The do have a military procurement expert on staff! https://endpts.com/the-department-of-defense-could-undermine-fda-giving-the-green-light-for-experimental-products/?utm_medium=email&utm_campaign=Wednesday%20November%208%202017&utm_content=Wednesday%20November%208%202017+CID_cde9e49ffc84ae8420a7e82059197e81&utm_source=ENDPOINTS%20emails&utm_term=The%20Department%20of%20Defense%20could%20undermine%20FDA%20giving%20the%20green%20light%20for%20experimental%20products
$ARTH long. Nice find. Makes me think of Arch also. Guessing they have external approval even before this could apply.
Bravo Marianne, thank you for this! at least maybe some good news for Arch Therapeutics 😉
Hey y’all, I don’t normally post I just lurk a lot, LOL. I have been heavily into Arch Therapeutics since it was $0.19 a share.
This business has been covered extensively in the threads, both on the main thread and on the old Arch Therapeutics thread that has since been closed.
I’m not telling you not to do your due diligence—that is something that all investors should do. What I will say is that there is no product to compare AC5 to. It is unique and revolutionary. The good doctor has researched the technology involved thoroughly, and met with the CEO multiple times. Cleveland has researched the management and financials thoroughly.
Get your due diligence done realizing that a lot of that has already been done for you and vetted thoroughly.
Truly revolutionary technology with over 200 applications and counting that have been identified.
Extremely long ARTH.
Well said
Does anyone know what happened to the price on Tuesday 11/7 when it took a dive from .72 to .48 and bounced back within hours? Who dumped a large position and why? Profit taking? Or is there some news coming? Perhaps an unsolvable mystery but somebody knows the answer
$ARTH- Mobilecc.. there’s a string of comments on the main thread..
https://www.stockgumshoe.com/2017/10/tear-sheet-cohbar-industries-cwbr/comment-page-12/#comment-4958724
$arth long. 5k traded pre-market. Almost never see that. That precisely orchestrated stop grab the other day, pretty decent volume yesterday…people are getting antsy waiting for news…
OTC stocks do not trade pre – post market hours. What you see are late trade settlements.
https://www.timothysykes.com/blog/do-otcbb-and-pink-sheet-penny-stocks-trade-premarket-or-afterhours-video-answer/
$ARTH
Im going to buy a. Condo in a town that is fun. I want to walk out go get breakfast maybe a snort..I’m tired of living the American drive lifestyle.. I started out working on high voltage.. Now doing security for those same systems.. What a strange crazy ride it’s been.. 38 years worth..Just need them to execute..
I have $HLMIX in my defined pension. These guys are up like 28% ytd if you want some international exposure.. GLTA
#pipe dreams
Check out downtown Denver, CO – but $ARTH will need to rocket to a much larger price to be able to do it. (Or maybe you have a Very Large position?) (No need to tell me.)
$ARTH ow
$ no investment value
A Fascinating Brain.
A most readable and interesting story from the NY Times
http://tinyurl.com/ybjv2muk
Arch Therapeutics 10-K:
Our long-term business plan includes the following goals:
· conducting required biocompatibility studies and additional clinical trials on AC5 and related products;
· expanding and maintaining protection of our intellectual property portfolio;
· developing appropriate third party relationships to manufacture, distribute, market and otherwise commercialize AC5;
· obtaining regulatory approval or certification of AC5 and related products in the EU, the U.S., and other jurisdictions as we may determine;
· continuing or developing academic, scientific and institutional relationships to collaborate on product research and development; and
· developing additional product candidates in the hemostatic, sealant, and/or other fields.
In furtherance of our long-term business goals, we expect to continue to focus on the following activities during the next twelve months:
· seek additional funding as required to support the milestones described previously and our operations generally;
· work with our large scale manufacturing partners to scale up production of product compliant with current good manufacturing practices (“cGMP”), which activities will be ongoing as we seek to advance toward, enter into, and, if successful, subsequently increase commercialization activities;
· further clinical development of our product platform;
· pursue regulatory clearance for commercialization;
· continue to expand and enhance our financial and operational reporting and controls;
· seek commercial partnerships;
· expand and enhance our intellectual property portfolio by filing new patent applications, obtaining allowances on currently filed patent applications, and/or adding to our trade secrets in self-assembly, manufacturing, analytical methods and formulation, which activities will be ongoing as we seek to expand our product candidate portfolio; and
· obtain regulatory input into subsequent clinical trial designs;
· assess our self-assembling peptide platforms in order to identify and select product candidates for advancement into development.
As of November 14, 2017, we believe that the Company has cash on hand to meet its anticipated cash requirements into the fourth quarter of Fiscal 2018
On July 25, 2017, the Company announced a 510(k) submission to the U.S. Food and Drug Administration (FDA) for its AC5™ Topical Gel. If clearance in granted by the FDA for the 510(k), the AC5™ Topical Gel will be used for external wounds. The Company is also working to scale up production and at the present time expects to have commercial product available in the second half of 2018.
everything seems to be proceeding accordingly – at least i didn’t find anything suspicious or outright wrong in latest 10-K. holding onto my atlas position of $ARTH and waiting for positive FDA results.
Deleted by poster, wrong forum!
wow! i wonder what’s happening there? 😛
#CHFS (deleted)
According to Schwab’s charts, the share price was $576 a year ago!
$CHFS The chart is crazy. Kick it back to the 3 year and it was almost $3500. Crazy low float but 9.1 mil volume today.
$CHFS Even crazier – they performed a 1:20 reverse stock split on 10/13/17. And the high point 4 years ago was $8280. There’s probably a reason, but on the face of it, it’s bizarre. Somewhere in all this there’s a change of name too.
OK back to ARTH. Sorry for going off-topic.
$ARTH ow
$arth could be the start of a monster run
Which way?
$ARTH atlas OW
I’ve been wondering if anybody else here is still holding onto their Arch Therapeutics shares full of confidence that this year will bring about change.
There was a lot of discussion about Arch in Dr. KSS main thread near new year, but soon after discussion has withered. I remember quite many telling they’ve sold their share in lack on confidence on CEO Norchi and way company seems to be trembling into every single crack infront of them
Correct me if i’m wrong, but i remember Dr. KSS mentioning 510(k) approval wouldn’t have been such a big deal – much bigger deal is just about commence in form of human tests on surgical patients. And this is only one of the mane things that Arch is working on. Norchi clearly pointed out that the questions FDA handed over to company are addressable (- it was Norchi himself who picked up the phone to call Dr KSS(?) about the matter). Re-submitting for CE-approval for Europe’s markets are also on the way. New products are on the pipeline. Also new patents should be pending. Dilution is still minimal and company has no debt. Still no competition around.
So my questions probably should be: What’s the fuzz? Or am i missing something?
I understand company cannot keep making promises ad infinitum and thinking shareholders will continue staying content when several months later realizing yet another bubble bursting and time is essentially running and every day spent without revenue is missed – no way – but i don’t think anything radical has changed even if they didn’t get one 510(k) approval just yet.
yours, Finn
$ARTH fp. Yes still holding knowing that we may have wait likely until the end of
2018, if not into 2019 for any meaningful catalyst. It may be very possible that the 510k may not get resubmitted until the internal use of AC5 is completed. This depends on the nature of the questions the FDA asked.
DR. KSS did mention the possibility that the questions the FDA wants answered may be related to AC5 safety or durability inside tissues rather than as just an external dressing. This would mean you would have to do some internal use testing which is difficult since you would likely have to reopen a wound to see if the AC5 has desolved, worked properly or is still present. Also, the question is how long do you wait after the surgery before you reopen the wound.
At least this is my understanding of where we are rigth now. Other Gummies please correct me if I’m wrong.
$ARTH ow, With all respect, I believe you are very wrong. Look at slide 21 of the Biotech Showcase presentation. Norchi, who knows what the FDA asked for, plans to resubmit the 510(k) as well as file the IDE for internal use, as well as file for the CE Mark – all in 2018. Also, the peer-reviewed paper on the clinical trial is imminent (slide 5).
$ARTH
Thanks for clearing that up JohnM. I am not touching my ARTH shares for a long time. I have been through at least two similar periods of uncertainty and and dip in price and in the end they turned out to be nothing. This is a small company and people need to be practical and give them time to grow. Look how far they have come in the last two years while burning so little money compared to any other biotech company. If you are looking for blazzing fast gains, ARTH will really disappoint you as it is and has been quite volatile. As long as the science is solid, we should be fine.
#Greenrider – $ARTH durability after surgery
If this question wasn’t answered already, they’d probably do the research on animals so there’s be no moral problem with opening up the wound again (except for making my animal-loving heart cringe). But I could be all wrong, and I won’t be offended if anyone corrects me.
Cheers,
Penny
$ARTH Np for anyone planning to buy ARTH , now is the time to do it with the stock at 0.45 cents…not scrambling when returns to $0.80 cents
$ARTH Whilst the science is strong, the financials resonable (and it would be interesting for Cleveland’s latest take), we have management issues. Fatal? I bet not, but would my shares be better in APTO – probably. However, it’s been a good few years in Arch and whilst two of the three are class leading and one “pillar” is weak I feel inclined to hold as much through inertia as anything else. But it is so frustrating and Norchi attacking Dr KSS was unpalatable. If it were in an account without tax implications I’d likely reduce significantly.
$ARTH I missed where Norchi attacked DR KSS. I didn’t see that in the threads. Was that on twitter?
I think what was said is that TN was frustrated with KSS because someone from the group was trying to get some answers to some questions. KSS, I believe, felt he had no right to blame KSS for anything. Im still long, Im not willing to sell underwater over an emotional reaction. I hope it recovers sooner than later, and then I myself might consider getting out, because I believe they may need to raise funds this year at some point.
Thanks for your response. I have thought they would need to raise money too. I have also wondered if the information the FDA is requesting is going to require another trial.
good question?
$ Tickers
ray D – would you please include $ Tickers with your posts, so that people following on e-mail will have some idea of who or what you are referring to. Thanks.
$ ticker Apologies, I didn’t realize people couldn’t see the thread title either.
ray D, we email followers can see the thread title, no problem.
ARTH. I wonder if TN is regretting his accusatory conversation with Dr KSS AND if he maybe now has a better appreciation of the SG investing group? I just wished that I had acted on what appeared to be a “cooling off’ on ARTH by Dr KSS and Cleveland, prior to the more formal acknowledgement; not based on science but the lack of execution.
I always try to learn from my mistakes and I will learn from this one.
ray D re;$ARTH Norchi was upset that Ron Oliver in our group contacted Elaine Whitmore. She should have been told by Norchi not to release insider information. Here is what started it all.
https://www.stockgumshoe.com/2018/01/the-twelve-biotechs-of-christmas-2018-balthasar/comment-page-4/#comment-4969480
She almost certainly WAS told by Norchi not to talk to anyone. Norchi’s anger should have been directed at her, not DR KSS – as I suspect he has figured out now that the stock has been taken to the woodshed.
$ARTH There were other conversations subsequent to Ron Olivers. I believe it was the one involving the FDA that TN had a problem with.
Read ARTH yahoo Conversations to obtain a much broader prospective of the situation, This blog limits counter views.
$ARTH….Not on twitter….in the same comment from Dr KSS where he stated he had sold all arth. I have lost all confidence in TN….there is no reason why he should have been angry at DR KSS because someone else in our group called and asked questions…DR KSS has always encouraged us to call companies ourselves when we have questions but evidently TN was miffed; makes me think things are not well with arth. I continue to hold all my arth shares at this time hoping for a better price in a few months or next year even. Already major overweight in our top 4.
I sold a lot of mine as well. I was severely overweight. Definitely lost on this one. That being said I would never blame Dr. Kss or anyone else on this board. I have always wondered why a company with such brilliant science hasn’t been bought out or why it takes so long for them to get anything done. It just doesn’t make sense. I hope that Dr. Kss returns. He takes time out of his day to help us all better understand the science behind so many biotech stocks. I for one have always been grateful for his vast knowledge and generosity and willingness to help so many of us out.
#Billionaie Tolga > I can’t harp on anymore about quality management. It’s understandable if things go wrong and you work towards rebuilding. To not be transparent is not acceptable. https://twitter.com/KumovaTolga/status/956055192524517376 Best2ALL
$ONCS reduced to skeletal 20180124 –
When the geauxing gets tough, the tough get geauxing….
$ARTH ow, $INO sp – Inclined 2 reduction – #TerryNorchi, #AvtarDhillon https://www.marketwatch.com/investing/stock/ino/insiders?pid=69647, #Cleveland and staffs nerd to nut up and come clean or reap the consequences of non-transparency! Feeling played by self-serving professionals. Absence certainly does NOT make this heart grow founder, in this situation. imho #DYODDNIAIA
Dueling Banjos https://www.youtube.com/watch?v=A8rUZfQJjPY 🙂
Ben,
Please help me understand your post. Obviously there are couple of typos, but what is the direct question for those of us who are not as well informed? Dhillon stretched too thin? Thx- Joe
$Ben
Okay times up. Somebody else please tell me what Ben is saying here. #Crickets
$arth
I don’t know what he is talking about, but I certainly don’t take it too seriously. Obviously he is not a big fan of Arch – or maybe just Norchi. I’m not overly concerned. They only thing I fault them with is screwing up the CE application. Meaning applying for approval of a drug as opposed to a medical device. I chalk that up to what can happen on a shoe-string budget.
I don’t blame them for having to pull the FDA application. From what I can gather, it could have been as simple as this. Imagine cutting yourself with a knife in your kitchen. Well there is a whole gradient of the severity of the wound. From a little “boo-boo” to something that requires a trip to the emergency room and stitches. And now we are crossing over into “internal” – and Arch hasn’t run those trials yet.
So I don’t blame Arch for not foreseeing that.
And we have yet to hear from Norchi about what just went down. And in our judicial system a defendant cannot be convicted on strictly one persons testimony. And to be clear – I am certainly not accusing KSS of lying. But people interpret things differently. It’s what makes the world go round. For all we know Norchi was referring to stuff KSS doesn’t even know about – meaning not Ron Oliver etc.
Nothing has really changed for me. I am still very long and overweight.
$ARTH
B&G63- Ben is overweight $ARTH and digs up alot of good stuff- so I know he cares deeply. That is why I want to understand what he was implying. Other than that I agree with what you have stated and appreciate your input. Thx- Joe
PS- B&G- Purdue? Colorado?, Vandy? Army?
blackngold63 – The Beatles released their first lp in the UK in 1963 called Please Please Me. The first ones produced had a black and gold label on the vinyl. Somewhat of a collector’s item, and I am a huge fan and serious collector. Here are a few items I have picked up..
http://www.fab4collectibles.com/AA158.htm
http://www.fab4collectibles.com/AA150.htm
Could’ve sworn Black and Gold 63 was none other than the big bad Bruins’ Brad Marchand!
I had people tell me they were sure it was a member of the Pittsburgh Steelers.
Very cool!
I still hold a very considerable position in ARTH, I am now underwater as of today..I am also curious as to Cleveland’s take on it..I’m not inclined to sell even though at this point there are probably better places to park the $$ and make up some of the losses.. are there any gummies holding out hoping Norchi gets his shit together??
I am holding. Sounds more just like a falling out than some of the conspiracy theories out there in yahoo conversations. Not a great place for accurate info imo, but I also don’t think it’s a cult stock. I think this is the FDA being maticulous and Norchi kind of not taking full responsibility for not coming through for shareholders. Sometimes you need to get burned to get a grip and that’s what Doc did (hopefully temporarily). I may be off base? I thought JCOLBURN had summed it up pretty nicely in a post yesterday, and I do think Cleveland is still bullish but he gave up trying to reason with us and our neurosis.
$ARTH medium position
I’m holding for now but will probably reduce to small once the price gets near $.50. I’m underwater but I’m comfortable holding for the long term since the good Doc said long term holders should be fine because the science is still good.
Hi Jerome50,
$ARTH still OW but underwater (in two separate accounts, even)
Yup, I’m hanging on. What’s that old saying? “This too will pass.” I still believe the science is good; it’s just that the execution hasn’t been up to snuff.
As others have opined, Norchi might just realize from the plunge in SP these past few days, that the Gummies are numerous – and PO’d – and perhaps it could behoove him to do something concrete to keep the faith out there.
(I haven’t been reading any of what appears to have been discussed on Yahoo, so have no idea what influence that area might be having.)
If there weren’t these other buying opportunities that Dr KSS and our other FABULOUS contributors have presented for our consideration, I’d be chomping at the bit to buy more $ARTH. (Calm down, Penelope, calm down!)
Cheers everyone,
Penny
If Norchi is ticked at doc for someone else calling in, how is that docs fault? He didn’t tell them to call in. If ARCH wants the price to go back up then make a damn statement. Let your shareholders know what’s going on. “We will have new FDA submission by ?” I’m hanging on for a while, but certainly disenchanted with management right now.
$ARTH OW and nibbling more. Of course it’s not Doc’s fault. Norchi is under pressure and took his anger out on the wrong person – he should have just gone after his FDA consultant, except she is a big frog in this little pond. Until he meets with the FDA, all Norchi can say is: “We will have a new FDA submission as soon as we can.” That is so obvious I doubt it would help the stock.
$ARTH The biggest cloud hanging over Arth is Norchi. His behaviour over the last few years is reminiscent of Benitec’s Peter French. French drove a promising Bio startup into the ground, ignored all advice from the Doc and basically went his own way to eventual oblivion. It look to me like Norchi is going to repeat the process. I’m still in but dont’t know why!
Yes. Benitec. It is the first stock I invested in after joining Gumshoe. Being a very naive biotech investor I invested an enormous amount in the stock, lost my shirt and just a couple of days ago broke even. I lost my shirt because I was stupid. I recouped my investment because of Doc, et al.
As such I have paid close attention to Dr. KSS has had to say. $ARTH may still be a golden ticket, but I am not on the train anymore for now, having upped my positions in the Fabulous Four as well as his other highly recommended positions.
After Benitech I also started to do something important called due diligence, but again with the help of so many others here that I am grateful for.
Peter French latched onto a possibly revolutionary technology, never advanced it, took forever to get it in the clinic, ignored Doc’s advice on the trials, and wasted shareholder money on unnecesary hires.
Terry Norchi latched onto a possibly revolutionary technology, advanced it with numerous new patents, got it into the clinic on a shoestring, showed it worked, filed for FDA approval, has Doc’s approval of “the best materials science I’ve ever seen,” and is, if anything, too parsimonious in hiring people.
If you think really Norchi is anything like Peter French, I suggest you sell ARTH immediately.
I need to address what I said about $ARTH. Having been involved in the fiasco with Benitec, in no way do I think that Dr. Norchi is ANYTHING like Peter French. I had been in $ARTH from the beginning and I have never thought Dr. Norchi was anything but ethical, and honest. I just think he may be in over his head at present, and hope that things will work out eventually
$ARTH np – sold out this morning put all in $VTGN fp and made money.
Long Dr. KSS
$VTGN
Smart moves Lannas!
/Helen
$VTGN long -Thank You Helen!
Helen, do you happen to know what the Doc is so upset about? I asked the question on the main page and got a zillion TD’s. I cannot find anything injurious to the Doc from Toddba. English is my first language and as far as I know I don’t live in a parallel universe so what am I missing? was the offending post deleted? I really can’t find it.
$ARTH
TWA I do not propose to cut and paste what I believe to be the offending post from Toddba but I think you will find it posted at 8.45 pm on the 22nd under the heading “$ARTH heavy and long”
$ARTH $KSS
In that case, to provide clarity to members who perhaps missed what happened:
I don’t think anyone sees Toddba as a villain here. Or Ron Oliver – who went out of his way to perhaps conduct one of the best self scuttlebutting episodes for a stock in the Gummy universe ever and deserves massive credit and praise for that. Ron if you are reading this, I never saw the comments you left that you deleted but I understand why you may of felt fustrated and perhaps mistakenly made to feel like an enemy in the mass melee following your invaluable work. Trust me when I say that everyone was very thankful for what you done, and the thumbs up on your post – 90+ the first time I saw it – tells you all you need to know. You’re awesome.
Moving on to what precisely made Doc leave – and I don’t want to speak for Doc – but people keep asking so here it goes:
I think Doc had been assaulted from all sides by Dan62 that in then being put on edge by that he then took issue with Toddba saying that after the recent ‘brush up’ involving $ARTH he was ‘not impressed’. Doc saw that as a slight aimed directly at him and his negative view of $ARTH as an investment based on recent news; as if Toddba snidely insinuated that it was Doc’s fault his investment was not performing. Toddba apologized but clarified that the meaning of his message was focused on TN’s handling of Ron Oliver’s recent call. And in fair review, I really do not think that Toddba’s intended meaning behind his message was ever aimed at Dr. KSS either, and that things probably got lost in translation for lack of a better phrase.
The real issue was Dan62, who left quite a few comments, many of which are gone now, treating Doc in an extremely hostile and toxic manner. Not something Doc should have to deal with.
–Open to anyone correcting this interpretation of events because of its importance. Especially Doc if you are out there. The sorest thing about this all is that I genuinely believe we’ve had a case of mistaken interpretation minus Dan’s comments. I hope with everything we’ve got that someone with a direct line open with Doc may be able to communicate with him and discuss what has happened.
Thanks to all for pointing me to the “Errant” comment from Toddba. I had seen it and drove right by. I have now read it 3 times and have concluded that I must be living in a parallel universe after all as I can find no slight aimed at the Doc in this comment. It must be me!
#twa14. You won’t find the main offender’s comments from Dan62 since it has been deleted by the good Dr. Dan62 is now in the penalty box for 2 weeks
Yeah, I saw his posts. I was going to ask Dan the lineman to climb one of his poles, grab the live wire and send us a selfie of the results but considering the frigid atmosphere I thought better of it!
No, it’s not
Hi Coyote. Thank you for your kindness and understanding, your compliment, and perspective. I found TN’s angry reaction and blame expressed towards Doc very upsetting and don’t quite understand it. The interview I did with Dr. Whitmore was very positive, I thought, but TN’s reaction to it having taken place makes me wonder if there are issues at Arch that are so tenuous, that he has a very short fuse these days.
As far as the post I deleted, I took it down as soon as I realized it was not what I wanted to say. In general, if someone self-deletes a post I would think it should be ignored. For anyone who saw it and didn’t like it, neither did I.
I find all that has happened very sad and unfortunate.
An article came out tonight in “Insider Financial” which is very much the way I currently see the situation at Arch now that the dust has settled somewhat.
https://insiderfinancial.com/arch-therapeutics-inc-otcmktsarth-stay-away-until-this-issue-is-sorted-out/175162/
Ron, you did nothing wrong in asking, but Dr. Whitmore should never have talked to you. She may have violated a confidentiality clause in her contract. THAT is what has Norchi upset.
The Insider Financial article says: “…a sell-off wave that has pushed the stock to all-time lows.” False.
“The stock is currently languishing at the $0.38 handle, after shedding more than 90% of market value over the past one month.” False.
” The developer of solid hemostatic and wound care devices was forced to withdraw its 510(k) notification for AC5 Topical Gel from the Food and Drugs Administration late last year. This was after the company failed to provide adequate responses to questions posed by the agency.” False.
Who are these bozos?
$ARTH Bohaha
Ron, over my career, I have had the pleasure of working with exceptionally bright people. What I have noticed, is that brilliance often comes at a price.
Keenly intelligent people are often sensitive and see or feel things that other people don’t notice. At times, they can be difficult to work with. Ask me how I know.
Doc, is one of the rare exceptions, but it is helpful to remember that he lives in a world a good deal more complicated than ours.
The General is often dealing with problems that the Private doesn’t even know exist.
Just trying to be helpful.
PetervR
#ARTH Brouhaha
You put my thoughts into words, Peter. If I could PM you, I’d ask you how you know!
Cheers, Penny
So is the bottom line that Arth is no longer a good bet? I’m completely out of the loop on whatever drama may have happened on the message board. I seriously am only looking for feedback from investors more knowledgable than me on this company.
$ARTH $FAQ
Julie you can use the comment search feature at the top of each article to find comments relating to your company of interest. Say you are interested in what has happened surrounding $ARTH, you can type $ARTH into the comment search of an article, and the website will sort all the comments for you that have ‘$ARTH’ contained within them. You will need to do some piecing together as it can be a bit of a wet jigsaw puzzle at times, but that’s half of the fun. 😉
Good luck!
#comment search $Travis – Wasn’t sure where to post this, but FYI, i was trying to share an article about $CWBR and fasting. I went to #comment search to see what others had already posted. I typed “fasting” into the main search box. Articles appeared on the left and comments on the right as usual, but when i clicked “read more” at the bottom of any comment i was connected to somebody other than the author of the comment. The comments were highlighted in yellow. The comments were dated Oct. 2017. I’ve had no problems with newer articles and searches.
Thanks,
Larry
$ARTH ow and nibbling more. Julie, Doc still says the materials science is the best he’s ever seen. We are about to get the peer-reviewed paper on the clinical trial. Then Norchi will meet with the FDA and discuss what they want ARTH to do to answer their questions. At that point, I expect he will finally be able to issue a press release on when he can refile for FDA approval of AC5 for external use in wound healing. That will be followed by filing for and granting of the CE Mark, the PMA filing for internal use, and more patent grants.
There are several large investors that support ARTH’s progress, and I expect they will pony up the needed capital again.
Norchi is under a lot of stress from the unexpected FDA delay and made a bonehead move in blaming Doc for ARTH’s FDA consultant talking to Ron Oliver. He’s done a great job of advancing AC5 this far on a small amount of money and building shareholder value, but he’s not perfect. I don’t fault him for the delayed clinical trial, that’s on CURAM. I don’t fault him for the botched CE Mark filing, that’s on the manufacturer. I don’t fault him for withdrawing the AC5 501(k) application, that’s on the FDA. But I really fault him for blaming DR KSS because the CEO works for the shareholders and we collectively held – and probably still hold – a heck of a lot of shares. So he isn’t perfect – surprise.
I hope someday he and Doc can sit down with a bottle of good wine and work it out because I think they are both smart, knowledgeable, entrepreneurial doctors who want biotech to change the world.
$ARTH np True, it is excellent science, but in biotech, although it is a necessary part, there is more to it. Management, execution, financial situation, competition, among others come to mind. So, unfortunately, good science does not necessarily equal success.
I’m not saying anything positive OR negative about $ARTH itself, so please do not take this as a negative post. I’m simply reminding us all that in biotech, good science is not the only requirement. GLTA!
Scots poet Robert Burns wrote …the best laid plans of mice and men gang aft agley, or often go awry.
Failure anywhere from conception through sales can lose all investment. Different person along the line would have been successful. Every man needs help now and then.
Juliejuice (love that moniker),
I think one of the problems faced by some members of this community, is that they expect Doc, and other knowledgeable Gummies, to make complicated issues simple and straightforward. I have, most certainly, been guilty of this myself 🙁
There is a perfectly normal tendency to feel that others, more knowledgeable than one’s self, can easily see the answers to complicated and intricate problems and issues. Unfortunately, this is often not the case, and all we should expect is the best efforts of the best experts. Even a casual review of Doc’s past comments indicates the frequent use of the words “nuanced” and “ I expect” – not, “I guarantee”.
Human nature desires simple answers to complex questions, and charlatans are always ready to supply them. Look at most any politician for clear examples – they will always tell you what you want to hear and will do everything possible to wriggle out of responsibility for the actual results.
I have seen numerous examples where Doc has suggested that the issues are complex and that final results cannot be guaranteed, but over-eager investors rush in and take positions anyway. Remember the adage, “Fools Rush In, Where Angels Fears to Tread” Gummies are no fools, but it is often easy to disregard caveats in the pursuit of profits.
I can think of few investment sectors that are as unpredictable as nano-biotech. Relatively few people are interested in reading the fine print, much less understanding it, so they default to the experts -assuming the experts know more than they do. To a certain degree this may be correct, but it certainly does not mean the experts know EVERYTHING. As a rule, the more you know about something, the more you realize how much you do NOT know.
When a respected expert, offers an opinion, it can often be interpreted as a “sure thing”, but this is NEVER the case. Doc frequently offers this caveat, but I feel his words are often “glossed over”.
Were you to ask me to name the people who had given me investment advice over the past 40 years, the first names to come to mind would be those who offered me advice that did NOT work out – welcome to the human race !
Small-cap biotech investing is just plain hard – no two ways about it, no one can make it simple or profitable for you – no matter how much they know. They can offer us “nudges” in the right direction, they can coach us, they can support us – but never expect that they can do the job for us. It’s not that they don’t want to, it’s simply because that is impossible.
Time to get off the soap box,
PetervR
petervr Well said and needed. You are always a calm helpful poster. IMO My father was rather plain spoken and something he often said was,,, Only damn fools are certain. I have never found an exception to that rule.
Unforeseen occurrence causes unexpected consequence.
Re $ARTH These comments from Dr KSS should put you back ‘in the loop’!
https://www.stockgumshoe.com/2018/01/the-twelve-biotechs-of-christmas-2018-balthasar/comment-page-4/#comment-4969494
https://www.stockgumshoe.com/2018/01/the-twelve-biotechs-of-christmas-2018-balthasar/comment-page-4/#comment-4969399
Believe #ZKSS is emphasizing that a $TWTR account IS required as well as driving home a point or two: “$CWBR up 8 percent pre-market. For me it’s up 100 percent in 6 months and certain readers still shun it, deathgrip on $ARTH shares. #whenwilltheyeverlearn?” https://twitter.com/KSSMDPhD/status/955784221389410304
Those readers bashed and attacked me for presenting $CWBR as a long idea. The most exceptional biotech in a decade, and I was ridiculed. Who looks ridiculous now? https://twitter.com/KSSMDPhD/status/955784851289989121
Totally do NOT understand why others are unwilling to share… hmmm
Gosh I hope #ZKSS receives the respect and love he deserves upon his return!
Habits of happy people:
1 don’t show off
2 talk less
3 learn daily
4 help less fortunate
5 laugh more
6 ignore nonsense
7 no entitlement
https://twitter.com/itswarrenbuffet/status/944531066605355009
The #BULLY shall find out that Karma is a beeotch 😉 hahahaha
If there is any type of KOL board established, it should be for #ZKSS not to have to review each and every post; the KOLB retrieving and submitting information, with links. NOT raw data, to him. Long #ZKSS and the #Gr8Gummune! #Best2ALL! ~ Ben, @H0U3
#CWBR bought in a few weeks ago and has proven to be a great investment
Thank you and #ZKSS for this recommendation