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My favorite part of the last webcast was where Norchi said he has NDAās in place with a few companies.
I take this to mean soon after approval (fingers crossed) there will be a partner deal for external use.
Long term holder – what is everyone’s expectations on stock price once Arth gets FDA approval?
What about on announcement of distribution?
Thoughts anyone?
$ARTH – also long.
Interesting question. I don’t think we will know till it happens. And it will happen. But the stock price right now is lower then July when it spiked to the 60’s for a day or two. The only thing that matters is good news. And we have had some since. But with FDA approval comes a CE application and also the licensing deal. Who knows. People are skeptical. I’m not. I’ve always believed in the science. And I think once one domino falls…..and then the next……and the next after that….. Well the stock price is going to go up as well. Beyond what we have seen .
$ARTH Long OW
Well, we are now past 30 days of the resubmission. Tick, Tick, Tick. . . .
$ARTH atlas long
possibly approx 60 more days to go, right? and probably even longer since apparently FDA hasn’t been too effective with their bureaucracy lately regarding 510(k)s.
have to admit it’s getting obnoxiously exciting to wait for the results. Arch has too many strikes to be able to wish for home run, but i haven’t lost my faith.
Some volume in $ARTH last two days, especially early. Intraday trading already from .301-.39. I hold and will continue, surely we’re getting close to some positive movement?
$ARTH – Arch Therapeutics to Provide Corporate Update at the 11th Annual LD Micro Main Event on Tuesday, December 4, 2018
“The presentation will include an update on the CE mark application that Arch plans to file for AC5ā¢ Topical Hemostat in Europe during the current calendar year, as well as the 510(k) notification for AC5ā¢ Topical Gel1 that Arch submitted to the U.S. Food and Drug Administration (FDA) in the third calendar quarter of 2018. As previously disclosed, the 510(k) notification is under review at the FDA. The company still anticipates that the 510(k) notification will be cleared approximately by the end of this calendar year.”
https://ir.archtherapeutics.com/press-releases/detail/516
ARTH long
$ARTH OW and Long
As we approach the 60 day mark of their recent 510K submission, I find myself thinking about how government agencies work and the fact that we will be in December shortly.
First, give a government agency a requirement that they must respond in X number of days and you will find that they will almost always respond on the X number of days, no sooner and no later. There is no glory in doing it earlier and potential black marks if done later. So if we assume that ARTH received confirmation of their 510K submission on the 30th of September and told us about it on 1 October, then the 90 calendar days takes us to the 29th of December, a Saturday. So ARTH should find out either on Friday or Monday of that weekend.
However, December is a holiday month and most government agencies will be on skeleton staffing for the final two weeks of the year with nothing getting done. Which means the FDA will have to have most of the work done in processing the 510K, including getting all the big wig signatures, prior to the final two weeks in order to meet their mandated response time. And that means that there is a chance that they might send their notification on the 14th or 17th of the month to ARTH. Call me an optimist, but there is a chance.
But I would not be surprised if it comes any time after that up to the 31st.
Or in January, as Norchi has said.
ARTH long… vita brevis.
$ARTH LONG ANG mega OW
Here’s to hoping!
Cheers – Todd
$ARTH – Arch Therapeutics Announces Submission of CE Mark File for AC5ā¢ Topical Hemostat in Europe
“As previously disclosed, Arch is seeking regulatory clearance in the U.S. and, following this initial clearance, potential clearance or approval for expanded indications. The company is also pursuing commercial opportunities for other AC5-related products, including use in open and laparoscopic surgical procedures. Arch continues to evaluate commercialization options and will provide updates when appropriate.”
https://ir.archtherapeutics.com/press-releases/detail/517
ARTH long
Arch Therapeutics Announces Positive Outcome of Ruling from Japanese Intellectual Property High Court
https://ir.archtherapeutics.com/press-releases/detail/518
Go ARTH Go. Last time it went up like this good news followed within a week. Hope insiders know good news is coming soon. Happy Holidays to all
$ARTH FDA clearance – https://ir.archtherapeutics.com/all-sec-filings/content/0001144204-18-064761/tv509257_8k.htm
ARTH: All Aboard! Next Stop AC5 510k Decision
https://tinyurl.com/ycut7397
$ARTH long and very OW
Hi Cleveland – what’s your best guess on partnership? After 510k decision?
Merry Christmas to all!
Todd
Hi Todd
This should pick up a lot of momentum.
Heck Norchi has been thinking of this commercialization moment since 2006. I am hoping it is JNJ and we hear in early 2019. However it maybe after the CE Mark. I am also hoping for up front payment. However should see exercise of a lot of warrants also.
Note reference to Pressure ulcers, foot ulcers, etc.
https://seekingalpha.com/pr/17359553-arch-therapeutics-receives-510-k-clearance-us-fda-ac5-topical-ge
l
Here is key statement— these are huge markets
“AC5 Topical Gel is a topical dressing indicated for use in the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds.”
See slide 12 for size of market for pressure sores, etc.
Slide Presentation
https://tinyurl.com/yczzdtat
Thanks, Cleveland.
Cheers – Todd
True, but what happened to the bleeding indication? We’ve been hearing this like you said, since 2006 and now no mention of this indication at all. Does it not work like it’s supposed to? Is there a problem with AC5 in this indication? What ever happened to the video of AC5 stopping bleeding almost miraculously? It has disappeared and never been mentioned again. Pressure ulcer ointments are a dime a dozen. While it’s nice to FINALLY see some sort of progress toward actual marketing of this product, the far “sexier” one was for bleeding. Where did it go?
Slide Presentation
https://tinyurl.com/yczzdtat
Conference Presentation
https://tinyurl.com/ybmh96r5
IMHO Norchi’s Best
bought 30k more.happy holidays. denno
$ARTH Long and OW – not to toot my own horn, but I believe I predicted a 14 or 17 Dec decision from that wonderful governmental organization called the FDA.
However, I am not too impressed with the SP move, although I am now green for the first time in almost a year.
Congratulations to all of us that have stuck with ARTH.
$ARTH, long & OW – Yessir, rlamore, you did indeed “nail it ” and I too have watched your day coming. Like you, I’m disappointed with price performance. I think we have to remember that ARTH’s repetitive non-execution, regardless of cause, has pushed investors away. The active loyal guard has shrunk to those who just put the stock away and out of mind. Now is time for ARTH to publish some periodic news to call back their supporters. There should be plans to announce about their post 501(k) activities – will ARTH now execute?
Hi Bob and Others,
Also $ARTH long and OW
Nice to see the comments from our long-term correspondents here (I miss you) – and great that $ARTH has provided something to be positive about. My Arch Therapeutics holdings have just about been the only bright spot in my IRA portfolio. They’re almost singlehandedly offsetting other more gloomy portfolio events.
At the back of my mind, though, is the unsettling history of earlier price rises for $ARTH, and I’m staying cautious.
Best wishes to all,
Penny
Ditto to that
General stock market downturn and $ARTH’s ups & downs:
Well, if this is any consolation to those of us in the US who have to take Required Minimum Distributions from our IRAs, a low valuation of our account/s at December 31 will mean that we don’t have to take as large a distribution in the nearish future.
I’m predicating my optimism on Mr Market causing stock valuations to go back up next year when the RMD has to be paid out.
Go $ARTH! (next year, not right now)
(This is my first year of being faced with a RMD, and now I’m realizing that it would not have been so good for me if I were a year older and the valuation was at December 31, 2017.)
where are the resent comments for arth?
Right here. Norchi is presenting to the Biotech Showcase Tuesday, Jan. 8, at 9 AM PST. Probably new comments after that.
Anyone catch the presentation today? This is trading terrible after the news as if everyone knows they need more $
Replay available on company website.
$ARTH atlas long
i was wondering if i’m the only one puzzled by valuation markets are giving to Arch Therapeutics. doesn’t seem fair at all :-/
yours humbly, Finn
Keep the faith. The process has taken a lot longer then the initial excitement by some were hoping for. But the fact AC5 has been approved by the FDA bodes very well. The CE approval may take months – but they should be able to get some type of licensing deal after. It may not be pie in the sky – but other products are similar. And yes more trials need to be done. But I don’t think that will go unnoticed by potential partners.
no worries, i’m holder of my incredibly overloaded position since 2015 š and totally agree with you, Arch still requires of us nerves of steel and few more months before something actually happens at least with the share price. so not giving up on my faith.
still cannot help wondering if all the initial promoters and enthusiasts have abandoned the company now that there’s actually something happening.
but as you said below, this game has many moving parts, those warrants for example etc.
Hi Finn,
Similarly $ARTH long & OW.
My husband and I have a joint hobby in overseeing our respective stock portfolios. He’s into gold/silver/oil stocks and knows he’s in no position to cast aspersions on my biotech stock choices.
Periodically I tell him, “Wait until ARTH gets to $10! ” (That’s per share, not for my total holdings) and we have a good laugh together. Then we say, “May we live that long!”
Happy New Year to everyone,
Penny
(These stocks are in the gambling part of our portfolios, so we can laugh.)
That was very well said, Penny, of both you and your husband š agree with you totally.
It sure has been painful period of waiting, at some point no end in sight, but when you add all those things Cleveland keeps telling us and corporate webpages’ information together, i’ve got no doubt we will reach those magical Nasdaq-required share price numbers eventually.
And it’s not about keeping faith, i’m no religious person, it’s about the science and progress Arch is making. There’s nothing like Arch out there, and won’t be for many more years to come.
yours truly, Finn
Ok! FDA has now approved AC5 so where is the jump in stock price? Am I being impatient? What should realistic expectations be? And yes Iām in for the long hall but expected more bounce.
What you need to realize is that they have raised money twice in the last year and a half – or whatever the timeline is. And with each stock sold there comes a warrant. And once it ‘hit’ and the FDA approved – well these investors are selling their warrants. Or stock shares. And just holding on to the warrants. If I remember correctly the last raising had a stock for 35 cents with one warrant that could be cashed in at anytime in a year or two for 55 cents. So the investor(s) are selling some off to get their money back. Which makes sense. Better now then later. But they are definitely not leaving the stock altogether. Just trying to re-coup part of a big investment. I wouldn’t worry. It may take a CE approval and licensing deal to see it move substantially. But you never know.
agree, this stock has been ho-hum at best. Was expecting a lot more bounce once FDA approval….quite disappointed actually…
$ARTH – Arch Therapeutics to Provide Corporate Update at the 2019 BIO CEO & Investor Conference
https://ir.archtherapeutics.com/press-releases/detail/522
ARTH looong
Hi Griffin,
Thanks for providing a spark of life on the $ARTH thread. Can hardly wait until Feb 11-12 – or something.
Cheers, Penny
$ARTH similarly looong
Yep … Feb. 11th at 2:15PM ET this coming Monday.