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I sold today...very frustrating...further delay with CE, now they need $5M for filing, and their operating cash is running very low..it was $5M as of Sept 30th, and burn rate is $1.5M. So as of now they have about $3M left. How are they going to start internal trials ?? Major dilution coming, and its delay after delay. Stock may not go down more, but its not going anywhere for next 6 months.
They need $ for internal trials, operating expenses, CE. I can guarantee FDA will not approve external with just 42 patients..CE might.
The presentation from 31st is already on their website. Same info as last one from 10th Jan. No access to audio though.
Bottom line..stock had a nice rally last few days...some people sold today in anticipation that tomorrow's conference will not reveal any new news. That is likely correct, as last one was just 20 days ago.
So its already priced for no new news, if so we stay at this price. If something new announced, we go back up.
Given volume, guessing it is some warrants selling...in which case it is good as ARTH gets more cash.
ARTH story is still the same..no changes in plan. Still expecting stock to AT LEAST be $1.5 by end of year. Some people want to take few % profits, no problem. They will be buying at higher prices soon. The story will get better as we move through 2017.
Friday's volume was huge...over 800k on no news when average volume is 277k. Something is definitely up. There is no trial results coming up either. Have to think it is someone inside buying that knows something. Stock has never rallied like this just for an upcoming conference. No one is expecting any new news when they just had a conference 20 days ago.
Only thing I can see is buyout news likely coming.
Company should REALLY start giving plan on internal bleeding trials...really hope we get some news on these trials in the JAN 31ST meeting.
any know why the breakout ? Some news coming...volume has been picking up quite a bit, so someone is buying big chunks of stock. I would not be surprised if J&J buys them out for $250 million. Very cheap for potential of this technology.
Lets not get too excited here...volume was average...so spike did not come with strong volume. Did someone put 'buy' order on the wrong ticker ?
Bottom line...if Arth ends 2017 with the following -
- approval of CE (or close to getting it).
- progress on FDA filings - 501k, IDE etc. with some approvals/progress from FDA
- Most importantly. completion of the internal trials..or close to getting results of it. For internal trials, 40 patients might be low...they should be looking at 100+ based on my research of other hemostatic devices pending FDA. No big deal.
Then we can see stock in the $1.5s...so double of current price. At that point should be news about moving to NASDAQ too.
For the upcoming conference in Feb, there are companies (like AKER) that has just $7 million market cap. So no, I don't agree that there is something special about ARTH being invited to this conference. There are companies way smaller in market cap also presenting. Lets not try to read more into this then there is.
http://www.meetmax.com/sched/event_35292/~public/conference_speakers.html?event_id=35292&bank_access=0
CE filing and FDA filing are important, but to me more important is the start of internal bleeding trials !! Based on what CEO said, are they applying for internal trials in US ? Or is it Europe ? Why would this be taking so long ? Who needs to approve their internal trials ? FDA ?
Good reading.
If Guardwire gets CE with 22 patients, we can easily get it with 40 patients. That answered my questions earlier.
Guardwire below is class III high risk...I seriously doubt AC5 is in the same category. The don't need hundreds (800 !!) of patients to get US approval for either external or internal.
The U.S. approval process for medical devices is very different, especially in terms of the scope and size of clinical trials required for high-risk devices. To receive approval to market a device in the EU, the manufacturer must demonstrate that the device is safe and that it performs in a manner consistent with the manufacturer's intended use. To receive approval to market a class III high-risk (and some class II) device in the United States, the manufacturer must demonstrate that the device is reasonably safe and effective. This typically requires a prospective, randomized controlled, adequately powered clinical trial involving hundreds of patients.
This significant difference is illustrated by the example of distal protection systems used in interventional cardiology. The first such system to be developed was a specialized coronary guide wire with an expandable balloon at its tip (GuardWire from Percusurge, Inc., which was later acquired by Medtronic). During a coronary angioplasty or stenting procedure, the device is inserted via femoral arterial access and the balloon is inflated distal to the lesion. After the balloon is expanded, the lesion is treated. The purpose of the device is to block any dislodged arterial debris from embolizing. After the lesion is treated, any debris is evacuated by aspiration and the GuardWire is removed.
In the EU, the GuardWire device was awarded CE marking by demonstrating safety and performance (i.e., the ability to aspirate material during the stenting procedure) in a 22-patient, single arm study.6 In the United States, this device was designated Class II. To demonstrate safety and effectiveness (defined as the ability to reduce complications associated with stenting of saphenous vein grafts) the FDA required an 800-patient, multicenter, randomized trial comparing distal protection to usual care (no protection).7
Some short on the yahoo board saying that a 40 patients trials done may not be enough for CE approval. Anyone have any input on other trials done for other medical devices for CE that were smaller trials ? ARCH showed safety and efficiency, so data wise they are good.
Thinking this is external bleeding, so a large trial (like needed for drugs, other non-medical devices, non-invasive etc.) are not really needed.
For internal bleeding, likely the patient size would be bit larger am guessing.
Heard the webcast...everyone knew end of Q4 for CE was 'best' case, and not likely. He is still targeting Q1 as he discussed in Oct last year. Plan is still the same. Just waiting for 3rd party to approve etc. so there has been good process.
Timeline is still the same. Q1 submission.
FDA discussion is definitely new news, and very positive. IDE for internal trails...is that being done for US ? Meaning the internal trials will be done in the US vs. Europe ?
Another presentation on Jan 10th ? Why. When is news of internal trials coming ? Why can't that start ? Why so much delay.
Lots of people here hoping for big moves of ARTH, but it won't happen with filing of CE. The BIG move will come once they complete the internal bleeding trials. If they start it early 2017, should be done mid 2017. That is the big winner. CEO should really accelerate on starting new trials. Results we already know are superb.
Three basic categories of hemostats are widely used in surgery today: chemical agents, thermal devices, and mechanical methods that use pressure or ligature to slow bleeding. Each has its benefits and limitations. However, nanotechnology is rapidly ushering in new medical technologies. This review focuses on the 'nanohemostat', a new class of hemostatic agent that stops bleeding in less than 15 seconds by using (RADA)4, referred to as nanohemostat-1 (NHS-1), a synthetic biological material that self-assembles at the nanoscale when applied to a wound, and compares it to the characteristics of the 'ideal hemostat'.
Hemostasis is a major problem in surgical procedures and after major trauma. There are few effective methods to stop bleeding without causing secondary damage. We used a self-assembling peptide that establishes a nanofiber barrier to achieve complete hemostasis immediately when applied directly to a wound in the brain, spinal cord, femoral artery, liver, or skin of mammals. This novel therapy stops bleeding without the use of pressure, cauterization, vasoconstriction, coagulation, or cross-linked adhesives. The self-assembling solution is nontoxic and nonimmunogenic, and the breakdown products are amino acids, which are tissue building blocks that can be used to repair the site of injury. Here we report the first use of nanotechnology to achieve complete hemostasis in less than 15 seconds, which could fundamentally change how much blood is needed during surgery of the future.
Went over the presentation, was nothing much new, but he did mention 'partnership'. Someone asked him in the end about market opp, and he said $5 billion for hemostatic, equal and more additional for sealants. I expect stock to hit over $3 by mid 2017, assuming they go as planned - CE submission, CE approval, FDA approval, 2 more trials start beginning 2017 with results summer 2017.
One disappoint I have is it seems their 4 employees are going on vacation for next 3 months. He spoke about 'year almost over'..wth ? There is 1 full quarter left in 2016. They just want to wait around for subgroup analysis ? and publish ??
This is a disappointment. Why not start internal trials in 2016 ? He already knows Curan folks. Start the enrollment ! Why is everything waiting for 2017 ??
I know 3 months more delay (compared to what he said 3 months back) is not a big deal...but still disappointing.
The event that will really pop this (if no partnership till then) is the internal bleeding trials. Really hope they start that very soon like January. They have already done tons of preclinical comparison with many of the leading competitors, and the results are amazing. Its all posted on this site here.
A year from now (mid 2017, assuming CE application done, CE approved, internal bleeding trial complete at Ireland, we will be seeing $5 (even without partnership, and minimal dilution of $4-5 million).
With partnership before that, we see $2.5 right away.
I don't see what the big deal is about funding 2 trials - one for internal in Europe, and 1 in US....it will need about $5-6million. That is peanuts. Even if they do a dilution, that's 6-7% dilution. Very small.
I really hope they accelerate on their plan..why do they need to do things in sequence ?
First get subdata.
then publish.
then file ce.
then do trials.
A lot of above can be done in parallel. Unless they are pushing it out a bit, so they have time to first work out a partnership.
It is clear the selloff early Sept, and even today is due to fact that there is no major catalyst or event next 2-3 months. Everyone knew there will be no major release yesterday either. They stated what was already released earlier.
So those selling are short term holders, but will all come back in 2 months or less. Later 2016, should see multiple events like ce filing, sub-data analysis report, initating of internal bleeding trials...I doubt management would sit idle.
Cash till mid 2017, so we are good from funding side. There could be partnership in 2016 IMO.
Now that timelines are out, trial results are out, plan for 2016 are out, one question remains -
Why the heck are they not starting the internal bleeding trials ?? CEO keeps pointing to how well internal bleeding is controlled..lets get this done ! I really hope they start enrollment in 2016 while they do the formalities for CE and FDA and publication.
To all the folks on this board..confused on why ARTH sold off last 2 days...
Its so clear. Some people are a bid disappointed with the timelines CEO is putting out. There was selloff first when he said CE will me end of year. Now mild selloff last 2 days is because CEO put a bit of a damper on the FDA timelines. Now he says 2017...maybe someone was expecting submission in 2016.
The technology is the same, the market potential is the same, so nothing has changed expect some resetting on some people who were hoping for a bit sooner paperwork.
Apart from that the release on 24th was very bullish, even more so than the trail announcement as it has more information.
why can't they start internal bleeding human trails now ? Why does that have to wait for publication, CE submission etc. ??
External met all objectives, start internal now..by Q12017 results will be out. They can do it again in Ireland.
Yes, there are some hemostatic agents, but none as easy to use, as quick and efficient as AC5.
This section is where AC5 fits in -
The existing defects of current topical hemostats and the need for further improvements make their use limited to relatively low efficacy conditions, and prevent their application in more extensive situations (5). In fact, at present time, the ideal dressing has not been discovered, and no single hemostatic agent is likely to be superior in every clinical condition. Therefore, there is still the need for the continued refinement of the composition and formation of such dressings. In addition, current hemostats are mostly only available for use in developed countries. These types of products, which can be life-saving in both combat situations and events occurring in everyday life, need to be made available to, or produced in developing parts of the world.
These are all published times for AC5 for internal bleeding hemostatic. For external 41% is very good, but like I said earlier, they really need to do a human trial on internal control. At the worst, it will show 50% improvement in timing.
The average TTH after application of AC5 was significantly less than 30 seconds, whereas the average TTH after application of the cellulose product was approximately four (4) times longer.
The average TTH after application of AC5 was significantly less than 30 seconds. The average TTH for the fibrin sealant was approximately 50% longer.
The average TTH after application of AC5 was significantly less than 30 seconds, whereas the average TTH after application of the gelatin-thrombin hemostat was over 200% longer.
The average TTH after application of AC5 was significantly less than 30 seconds, whereas the average TTH after application of gelatin took over four (4) times longer.
From one of their older articles, comparing AC5 to popular sealant fibrin used in surgeries -
The average TTH after application of AC5 was significantly less than 30 seconds. The average TTH for the fibrin sealant was approximately 50% longer.
For external it is 41% less time vs. standard, for internal it is 50% less vs. standard.
They really need to keep the momentum going...1H 2016 was all about multiple patents, enrolling for human trails, getting great results. I seriously doubt CEO is smarter to keep silent for 5 months, and then file for CE. He will definitely present some new information, game plan in the Sept 11-13 conference.
I think he should start internal surgery trails in 2H. Why should this wait for CE ? Still feel internal will be the goldmine, as all current data shown on their site is based on internal hemostatic. Should see 70-80% reduction in bleeding time. Pigs bleed just like humans.
Agree he should done better job in the results release, with more information about next plan.
For those worried about 'dilution', this company is not finding cure for ALZ or cancer. It does not need 2 years of trials, expensive FDA engagement, hundreds of participants in multiple locations. Next trial maybe internal surgery hemostatic, again 40-50 participants in 1 location, takes 6 months to complete.
So any dilution would be around $4 million..that is about 5% of market cap.
Apart from that, they surely don't need lots of $ to pay for 4 employees and 1 office space. They got some $ from the warrants selloff that happened in July.
Not sure why 5 bucks will 'take a while' ? 5 bucks is about $700M market cap. Once they get CE, and get FDA PMA (both should be in by a year from now), this stock can easy see $700M. That is not a huge market cap. You need to look at the market opportunity.
Go back and read the presentation from their website from 29th June. This will make you realize that 41% improvement from 'control' or standard care is actually very good. They need to be clear on what the standard care was...fibrin? gelatin?
People maybe thought 'control' was placebo, which caused the selloff yesterday.
This is why the expert panel board said they are super excited about this product in the press release.
I agree they should be clearer in their release. Hope they have another presentation coming up, or news release. How about earnings release ?
They need to update their milestone page on their site.
http://www.archtherapeutics.com/technology/milestones
ACS will be classified as a class III by FDA... I think I posted this earlier too. You can search FDA medical devices site for pending approvals, and other hemostatic devices are all class III.
I think now that they have confirmed safety and efficacy, they should start planning for trial for internal use for surgeries. That is the goldmine. That was tested on rats and pigs and worked so well.
Apart from almost 50% reduction in hemostatic time, lets not forget OTHER reasons why doctors would prefer using AC5 for external and internal, instead of standard care -
Drawbacks of these products can include a combination of the following:
1.Unreliable, slow onset of action
Does not stop bleeding
Foreign body reaction, adhesion, granuloma formation, delayed healing
Infection
Difficult to prepare and use
Intact clotting cascade required
Animal/human sourcing
Must be kept dry or wet surface causes poor performance
Removal required
External application only
Toxicity potential
Narrow indications
Glue-like
Internal surgery in pigs, rats has shown very fast hemostatis, easy to use, clear, irregular etc. This is the gold mine IMO. They really need to start planning the trials for this on humans. It will definitely show very similar results.
Doing it externally on skin did some a slower hemostatis, but still about 1/2 the time than standard care. That is in itself a big achievement.
The market for internal is $7 billion or so, so this is the main market.
I bet if they do the subgroups analsyis, people with blood thinners were lower, but normal people were above 50% faster. That itself is a big win...most people are not on blood thinners.
My questions to management -
[1] why the delay for CE ? Do they want to get the subgroup information, which may show some subgroups performed better ?
[2] When are they planning to start trials for internal surgeries. Think this will be the big bet, as it clearly shows internal surgeries in rats was very good, easy to use etc.
[3] What is plan for US FDA PMA ? They are saying they are planning for it.
I guess I answered my own question..it will be a class III. Saw other hemostatic applications listed in the link, they seem to be all class III.
Does anyone know how long CE mark takes ? I read that PMA approval takes about 180 days. My guess is CEO is going to apply for both CE and PMA once results are out. CE looks more at safety, and FDA looks at safety and efficacy. Which is why they are doing the trails...to show both.
Does anyone know if this will be classified as class II or class III ? Thinking it is class II. Class II gets FDA approval much quicker than 180 days..could be 1-2 months.
Look at examples, this definitely seems to be class II -
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
Someone earlier mentioned 'late summer' as now Sept/Oct...I really think that is incorrect.
CEO said 'late summer' when he presented in early June. Last patient checkup was early July. For 46 patients, one month is way enough time to get stats, and present data beginning to mid August. CE approval will come sometime mid to late September.
If they need to do another trial for internal bleeding, that would start later in 2016. They also are applying for PMA with FDA.
My estimation is stock over $1 by Aug end, over $1.5 by end of year. This is taking into account bit of dilution - maybe another $4 million offering. Warrants sold recently should have got them some $.