by DrKSSMDPhD | December 18, 2017 11:08 am
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Source URL: https://www.stockgumshoe.com/2017/12/special-update-from-arth-ceo-norchi/
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Long $ARTH – Here’s a post on the iHub board by a guy called ZiptraderO…any thoughts? “Please see my posts from last month for background on the process for 510(K) clearance. I did express my concerns that there was a problem with Arch’s application. Rather than likely receiving an NSE (rejection) Norchi pulled the application. Did anyone notice that at the LD Micro conference just over two weeks ago, he reset expectations that AC5 would only possibly be cleared as a “wound dressing” by January 17, 2018 and that Arch would then apply again with a new 510(K) to add on hemostasis. You can see the webcast today on their website, although I would not be surprised if they take it down. Check out slide 22. He spent less than 20 seconds to explain what most investors would have thought was a major change in direction. Roth Capital Partners dropped coverage of Arch following that presentation. Now Norchi would like us to believe that whatever problem they are having getting clearance for AC5 will be a setback of no more than 3 to 6 months and that a new 510(k) application will solve the issues. I take that as a best case scenario, but believe it to be unlikely to play out as he says. The 510(k) discussions normally start months before an application is submitted with pre-submission talks, and continues through various timed processes with the FDA. So Arch and the FDA have discussed AC5 for about 9 months already. To claim he has new data to present to the FDA seems unlikely as there is no ongoing study of AC5 to yield that data. Logic tells me that he has been told he will need to file a de Novo application or possibly a PMA so more likely we are looking a delay of approximately one to two years. If he files a 510(K) again it can’t be different enough from what he has already filed to be successful, I would think. One problem I see is that Norchi was looking for approval for both partial and full thickness wounds, but my understanding is that the human studies were only done on partial thickness wounds. What I have just presented is in my opinion of the most likely outcome. I don’t think Norchi is shocked by this as in his yearly report (10k) under “risks” he states the FDA may ask for a PMA because (to paraphrase) AC5 is so novel. My belief is that the advice he was given to file as he did was not good advice and not good planning. Also in the risks section of the 10k Norchi states that he has certain obligations and timeframes he must meet to keep his license with M.I.T. for AC5 (That agreement goes back to around 2006) and Norchi has never specified what the milestones are. So the worst case scenario is that Arch loses the license. I think as reasonable investors we should set our expectations between the best case and the worst. I won’t buy shares until there is a plan that can be understood, points towards success, and is transparent. Right now I think the stock is going to be stuck in a trading range, close to the low .50s but as months pass, I will not be surprised to see the price hit a 52 week low. As far a suitor coming in to the rescue, I see that as unrealistic. Why it hasn’t happened already, is anyone’s guess. This is my opinion and I am not suggesting you buy or sell shares. I currently own none.”
$ARTH Only 1 institutional holder and with 20,000 shares. In light of the European CE mark issues combined with low institutional interest, I decided to sell mine a while ago as I needed a little more certainty in my biotech investing life. Good luck to all the longs here.
sounds like those could be words of former username watermaven who decided to unsubscribe from SGS after being criticised over pieces he/she wrote earlier about Arch Therapeutics similar to this one.
watermaven’s comments on Arch on Dr. KSS’s treads raised a lot of talk and questions couple of months ago but mostly his/her concerns were addressed and forgotten by most(?)
I don’t know about this matter enough to comment any more, and i certainly am not one to talk about Arch Therapeutics, just telling how i felt after reading that.
$ARTH Same person different skin
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=137117011
Once again a ton of misinformation. This person is going all over the internet and refuses to talk with Dr. Terry Norchi.
He claims his information comes from the FDA. The people he spoke to are not relevant people pertaining to ARTH. He talked to a person who picked up the phone. He has listed FDA names he has talked to so those are being reviewed. Since all ARTH relevant FDA personnel and related information are confidential any relevant FDA person talking to him would be fired.
Roth analyst Michael Higgins joined a new firm. Ladenburg. This person is dreaming.
ARTH as disclosed got a new communication with questions last week. MDUFA clock did not allow for extension.
Dr. KSS wrote a short column on all this over a week ago.
Long $ARTH – One thing I do wonder is why the FDA waited until the very last day to hit Arch with apparently tough to answer questions. Is that normal behavior for the Agency? Did Arch literally get the call 24 hours before the clock ran out or did they just run out of time on something the FDA had addressed earlier in the process. It matters.
Well, it matters and it doesn’t matter. I have many roles in this forum, but I view mine in this instance as that of reporting, precisely, accurately, clearly what Dr. Norchi told me and asking a few questions to limn his answers, most of which he could not for sake of decorum answer. I do regard Dr. Norchi as a colleague who has given this forum exceptional access to him and to his operation. Readers must understand that I cannot have it multiple ways: I cannot start lobbing Mike Wallace style questions at him and expressing doubt because in this case, in this instance, that’s not the nature of my relationship with him. I am certainly not his PR guy, but Terry does not give access to all and if I become impecunious, I forfeit that good relationship with him. Therefore, I am left with rendering what he said exactly as he said it and taking it at face value. I think that if readers doubt the veracity of what he is saying—and it’s certainly within your prerogative to do that—then one should also rightfully question whether investing in ARTH remains a good idea. Only an individual can decide this. If you decide to exit Arch, no one’s going to ban you from the forum or speak ill of you….we are not a trading advisory. I just remind you that Terry told me that the FDA was in so many words apologizing to him and the company for how things seemed and that it could not grant more time. I don’t think there are liars or bad actors here. I think a radical new agent is at hand, IN the hands of a young company, and that there are certain growing pains.
Regarding $ARTH, first thank you for the opportunity to be grateful. No words suffice. Without you and Cleveland I would never have invested in $ARTH which I believe will be end up to be a wonderful cornucopia. It is my largest position held since the 1st quarter of 2015. It’s just that it’s been a long time with not much happening, and sometimes I get a little exasperated. However it takes only a zeptosecond (had to find something smaller than a nanosecond) for me look to $AUPH, $APTO, $HALO, $CWBR, as well as others I have invested in based on your mentoring.
Long $ARTH – Thanks for the words Doc. I understand the delicate situation you’re in with Norchi and appreciate any and all tidbits you disclose here from your conversations. Young company, growing pains and OTC:BB pretty much define the situation at hand and one that I’m all too familiar with from cutting my teeth on tech stocks in the late 1990’s. There won’t be any exiting $ARTH here. I don’t ever buy any penny stocks (now) in an amount greater than I’m willing to lose my entire investment on if proven wrong. I’m pretty confident that’s not the case with Arch. And boy…Is this a radical product or what! 🙂 Best!
UFO
have no doubt Doc, we appreciate and honor all that you’re doing for Gummune. Your wisdom and insight are priceless!
Merry Christmas!
$RXDX $RHBY $APTO $HALO
A Bloomberg article offers more color on the Ignyta (RXDX) buyout:
– Roche to buy RXDX for 1.7 billion, representing a 74% premium. Deal is expected to close in 1Q 2018
– Deal comes five weeks after Bayer licenses similar drug from competitor $LOXO
– RXDX’s experimental product homes in on specific mutation; therefore, it’s tissue agnostic. In a way $APTO’s CG’806 shares many of the same characteristics, targeting the FLT3 and BTK pathways, and has the potential of showing benefits in multiple indications. AML is just a start.
– RXDX was founded in 2011 by University of California, San Diego researcher Gary Firestein and Jonathan Lim, the former chief executive officer of Halozyme Therapeutics Inc.
Dr. Lim has founded at least 3 to 4 highly successful biotechs that I know of, including RXDX which I bought for the first time at its IPO. In the future I would be willing to buy into any new venture Lim may choose to be involved in, regardless of discipline (or even with my blind folds on.) 🙂
https://www.bloomberg.com/news/articles/2017-12-22/roche-to-buy-u-s-cancer-drugmaker-ignyta-for-1-7-billion
$RXDX long.
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$ARTH – making lemonade out of lemons. Long and OW
I hold ARTH in a number of different accounts, mostly IRA, Roth and Keogh. But I do hold a bunch in an individual taxable investing account. So I just sold a bunch of ARTH in my individual investing account to take a lost for this tax year. I plan on buying the stock back on or after 22 Jan. You have to have held the stock for 30 days prior to the sale and to wait 30 days after the sale to buy back in order to be able to claim the lost. I am betting that ARTH is not going to have a big pop for several months and should be able to buy it back at a reasonable price.
If nothing else, I get a deduction off of my investing income for 2017.
No Ticker
Good idea…take your loss in $ARTH then buy back. FWIW…I see a correction in the QQQ`s starting sometime in January so I bought QID today.
If you can’t be smart, be lucky. Sold a moderate amount of $APTO on the 26th, Bought it back for less yesterday.
$ARTH – np – I wasn’t sure which thread is more up-to-date for ARTH so chose this one…..
twa14 posted this video on the Clubhouse. I watched it through to the end and I thought it was appropriate to post here, hope you agree. It would lend to why Norchi is sure to cross all Ts and dot is. A real eye opener for medical device Companies and CEOs.
https://goo.gl/imHm5c
You are spot on with the video. It certainly shines a light on the extreme danger of being a CEO of any company the FED has picked to bring down.
The arrogance and complete lack of morality by the four prosecutors responsible for Howard Root’s case leaves me angry and sick to my stomach. Prosecutorial misconduct should be considered an embarrassment to them and something to avoid. But they know they’re immune to recourse by the system they abuse. At that level, its all about promotion and power.
ARTH 5x ow What might have been, but isn’t: an interesting development. This is not investable, and I find no info on its website related to a measured drying time.
“State College, PA, January 2018- Biomaterials and medical device start-up, Aleo BME, has received notification from the U.S. FDA that it has been approved for the sale and licensing of ElaSkinTM as a liquid bandage for the protection and treatment of a broad set of skin conditions and injuries. The 510K clearance introduces the market to a dynamic product capable of partly addressing the $10B global wound care market and is the first product to come from Aleo BME’s growing platform of bioactive polymers being developed for in health care, cosmetic, and agricultural applications.
ElaSkin’s development began in 2016 and validates Aleo BME’s approach to biopolymer production and characterization and demonstrates an ability to enter critical, regulated markets and produce medical devices that can benefit large patient populations. Aleo BME’s development pipeline also includes medical devices for unmet needs in the fields of endoscopy and neurology, enabling biopolymeric solutions that recognize the unique biology of diverse tissues. Offering to put the 510K clearance in context, CEO Chao Liu says “ElaSkinTM is a best-in-class technology that has a lot of potential uses in health care beyond the growing liquid bandage market. Its structure and strength afford it a degree of comfort and durability that no other marketed, biocompatible material has achieved. We’ve found a lot of uses for this science, but the breadth and growth of the wound care market makes it a great place to start.” See: http://www.aleobme.com/elaskin.html