markm
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Post by markm on Aug 10, 2016 22:32:25 GMT
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Post by furbush87 on Aug 11, 2016 2:31:57 GMT
that is actually quite fascinating from a medical standpoint, it makes perfect sense that it is a device. I'll have to dig into it to see if I think it is a good investment.
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markm
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Post by markm on Aug 11, 2016 16:54:39 GMT
Agree. Acts as a barrier and does not interact with anything. 200+/- Applications
Attributes of AC5
Synthetic peptide
Clear liquid, squirted or sprayed-- Can see and operate through it
Conforms to irregular wound geometry Physical mechanical barrier (no metabolic activity or chemical activity with the body)
Classified as Medical Device in Europe because of no interaction with the body No sign of interaction with human cell receptors or cell kinase enzymes
Stops bleeding promptly
Faster time to stop bleeding versus five different popular marketed products
Blood thinner agnostic—only hemostasis product that is.
Efficacy even in presence of “blood thinners” Bioasborbable
Natural amino acids, non-animal
Enables normal healing
Non-cytotoxic, non-pyrogenic, non-irritant, non-sensitizer
Stores at room temperature
Indefinite shelf life
Simple, effective, versatile, safe universal
There are many other hemostatic agents, but:
* They all rely on using the patient's blood,
*They all take minutes to stop bleeding, not seconds
* None of them create a clear seal that a surgeon can see through
* None of them work just as well on people on blood thinners
* None of them work in every situation where bleeding has to be stopped
Arch's AC5 product solves all these problems.
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markm
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Post by markm on Aug 12, 2016 16:47:08 GMT
One of the 200+- applications for AC5 is Pressure Ulcers or Bedsores: Number affected: 2.5 million patients per year. Cost: Pressure ulcers cost $9.1-$11.6 billion per year in the US. Cost of individual patient care ranges from $20,900 to 151,700 per pressure ulcer. Medicare estimated in 2007 that each pressure ulcer added $43,180 in costs to a hospital stay. Lawsuits: More than 17,000 lawsuits are related to pressure ulcers annually. It is the second most common claim after wrongful death and greater than falls or emotional distress. From Government Website: www.ahrq.gov/professionals/systems/hospital/pressureulcertoolkit/putool1.html
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markm
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Post by markm on Aug 14, 2016 15:31:26 GMT
Anytime a hole in the body occurs one needs to worry about bleeding, leaking and contamination to mitigate infection. Arch’s AC5 to address these needs. Arch intends to transform the landscape of interventional healthcare with products to seal and protect leaking and bleeding tissue.
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markm
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Post by markm on Aug 18, 2016 23:46:54 GMT
Arch Therapeutics ARTH Dr. Norchi INTERVIEW -- Arch Therapeutics’ President and CEO, Terrence Norchi, Featured on “Small Cap Spotlight” Podcast Discussing First Product, Clinical Trial Significance, CE Mark Process, and Other Items August 18, 2016 Small Caps Podcast on Arch Therapeutics www.archtherapeutics.com/news/media/detail/1222/arch-therapeutics-president-and-ceo-terrence-norchi Other MISC postings from SA Electric Phred , Contributor Here are some of the musings of a vascular surgeon buddy with whom I share the release: "... . . . the big deal is that it is safe in humans. The 41% faster hemostasis in nice, but so what. No one would use this kind of product on a skin lesion excision. Now they can move forward with additional studies using it for where it could have a HUGE impact. With more major bleeding, this really looks revolutionary. ALL the other topical hemostatic agents rely on the clotting cascade. This is a sealant that (if you watch the rat video) you can get results in actively bleeding surfaces. So I think cardiac, vascular trauma and ortho surgeons would love it. Also could use in an outpatient wound clinic setting where they do a lot of wound debridements (excising slough and dead tissue from chronic inflamed wounds). One could do a much more aggressive (better) debridement and not have to wait forever holding pressure while the bleeding stops. ...I do appreciate your reaching out to me on this. I'm rather fascinated by this stuff. I think I'd use it like crazy if I had it." OK so he likes it but I still haven't convinced him to buy the stock. But he's convinced me to hold mine (or perhaps engage in more panic buying if we go back to the 50's) One of the values of SA is reaching out to practices like this and sharing their observations. Bill in Shanghai 20 years ago I was the Canadian distributor for a collagen product, Avitene, used for hemostasis (to stop bleeding) tinyurl.com/hj8... the product takes minutes to work but it was a highly successful product that surgeons counted on because it worked. Bleeding during surgery is a serious and potentially life threatening factor of surgery. Avitene sold in 1990 for $30 for a small sheet and price was never an issue. AC5 works in seconds, once on the market there will be fast conversion. Surgeons need this and will use it as soon as a bleed is identified. Arch Therapeutics IMO is a strong buy Another Article www.massdevice.com/arch-therapeutics-touts-1st-human-novel-blood-control-device/
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markm
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Post by markm on Aug 19, 2016 17:59:22 GMT
Future ARCH Financings
I am beginning to doubt whether there will be any future stock financings in light of what I am seeing in recent JV deals.
I see people are attempting to talk the Arch price down talking about stock financings. Look they had $ 5.7 million cash per recent 10-Q. I believe another $ 1.9 series E warrants were exercised recently. They burn $400,000 month. Thus 17 months of funding.
Study these and note size of numbers and dream about ARTH. Imagine if they did a deal for just 50 of the 200 potential applications.
Remember we only need $ 8 to $ 12 million of additional capital to get all the human trials in Europe AND USA per SEC filings. This is SMALL. A JV in Europe could take care of this easily.
Study these recent deals to see how big the numbers have gotten:
Little MEI Pharma rockets up on $25M cash injection, deep-pocket partner for PhIII AML cancer study (market cap $ 67 million---royalty in high teens)
"This morning, MEI $MEIP is taking the wraps off a development deal with Switzerland’s Helsinn designed to shepherd the HDAC inhibitor pracinostat through a pivotal study. MEI gets $20 million in near-term cash —$15 million up front with a $5 million milestone at the start of the Phase III — along with a $5 million equity investment. And there’s $444 million in milestones on the table for success, along with royalties that can be earned from Helsinn’s marketing efforts"
"Advaxis Inc. ADXS, +5.48% shares spiked 28% in pre-market trade Tuesday after the company announced a $40 million agreement with Amgen Inc. AMGN, -0.15% to develop and commercialize cancer immunotherapy treatment ADXS-NEO. The agreement includes a $40 million upfront payment to Advaxis and a $25 million purchase of the company's common stock by Amgen, along with sales milestone payments of up to $475 million and additional royalty payments based on global sales."
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markm
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Post by markm on Aug 21, 2016 3:51:24 GMT
A Story in the FUTURE
Source: Doctor shareholder of ARCH
It is midnight in rural America. At the tiny emergency facility there are no doctors on staff at this time. A person is rushed to the facility puking blood. What does the nurse do? She has him drink AC5 to stop the bleeding. Next day the doctor addresses the cause of the bleeding.
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markm
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Post by markm on Aug 21, 2016 17:11:19 GMT
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markm
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Post by markm on Aug 22, 2016 14:19:51 GMT
Regarding margins on AC5----$ARTH I have spent a fair amount of time trying to determine this so let me try and add some color.
So from the current company presentation:
“Arch is a small public company with a medical device pathway, relatively low capital requirements and potentially high margin novel products targeting large growing markets. ”
“Potentially high margin novel products.” So what does potential “high margin” mean per my estimates?
At scale I estimate $ 400-$500 typical sale per application (2cm by 2cm area) with my estimated calculated cost (based upon discussions with several experts in the field–these shall remain confidential) of anywhere from 5% to 20%. So profit margins of anywhere from 80 to 95%. The key word is “scale.” I believe the profit margins will tend to the high side.
Look at the cost of pressure ulcers or bedsores–Do you think Arch can do better than $20,900 to $151,700 per pressure ulcer ?? Per Bedsore !
Number affected: 2.5 million patients per year.
Cost: Pressure ulcers cost $9.1-$11.6 billion per year in the US. Cost of individual patient care ranges from $20,900 to 151,700 per pressure ulcer.
Lawsuits: More than 17,000 lawsuits are related to pressure ulcers annually. It is the second most common claim after wrongful death and greater than falls or emotional distress
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markm
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Post by markm on Aug 25, 2016 0:37:47 GMT
The market for AC5 is unthinkably large: Every soldier in the world will need a bottle of AC5, every policeman in the world, every ambulance, every gun club, every ER in the world, every first aid kit in every office and manufacturing plant in the world, every person on blood thinners, etc. A billion or more bottles?
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markm
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Post by markm on Aug 25, 2016 22:24:07 GMT
Could This Device Offer Faster Bleeding Control?www.mddionline.com/article/could-this-device-offer-faster-bleeding-control-08-24-16Posted in Research and Development by mthibault on August 24, 2016 Arch Therapeutics' AC5 Topical Hemostatic Device was found to be safe and faster at controlling bleeding than standard treatment in a small trial. What makes this technology unique?Share Marie Thibault It's so far, so good for the AC5 Topical Hemostatic Device. Recently released topline data from a small study has shown the solution is safe and achieved hemostasis of skin wounds 41% faster than standard treatment. AC5-developer Arch Therapeutics is planning to use these study results in a CE Mark application for the device. The AC5 device doesn't look like your typical device. It is a slightly viscous liquid that Terrence Norchi, MD, president and CEO of Arch Therapeutics, compares to the consistency of alcohol-based hand sanitizer. Still, the product is expected to be regulated as a device because of its unique technology. Norchi told MD+DI that the topical AC5 consists of self-assembling peptides that interact with the highly charged environment of a wound to build itself into a physical barrier over the wound. AC5 is being regulated as a device in Europe and is likely to be viewed similarly by FDA. Norchi pointed out, "It's that self-assembly that has allowed us to go down the pathway of being a medical device rather than a traditional drug . . . A device is something that requires for its primary effect neither metabolic activity nor chemical activity of the body. The fact that [AC5] will self-assemble out of body, without being metabolized, that it will do so in your pasta sauce, is very supportive of this being a device." The 46-patient study was the first to test AC5 in humans. Each patient in the study had at least two skin lesions that were removed under local anesthetic. Each patient received both treatments—one on each wound—wounds were randomized to treatment with AC5 or standard therapy with a sham application of saline with a syringe. The primary endpoint assessed safety through 30 days post-procedure. Neither the control group or AC5 group had any serious adverse events and the two groups had similar safety results, according to a company press release. Importantly, a secondary endpoint evaluating wound healing found no evidence of AC5 having any detrimental impact on healing. Time to hemostasis was measured as a secondary endpoint. Wounds treated with AC5 had a statistically significant faster median time to hemostasis—41% faster than wounds in the control group (p<0.001). "We’ve seen ranges from 10-15 seconds to half a minute to certainly under a minute. We're not looking at times north of a minute," Norchi said.
Study principal investigator Jack Kelly, MD, a plastic, reconstructive, and aesthetic surgeon and professor of surgery at Galway University Hospital in Galway, Ireland, said in the release, "These study results indicate significant potential for AC5 in the treatment of bleeding skin wounds. The safety and efficacy outcomes for AC5 in this study were impressive and reassuring. While possessing a safety profile at least as good as that of the control group, AC5 was associated with a clinically significant improvement in time to hemostasis." The study excluded patients with major underlying conditions like active malignancies, pregnancy, or organ failure. But, of the 46 patients studied, 10 were on one antiplatelet product. Data from that subset of patients will be analyzed to determine whether they experience a similar desired hemostatic effect with AC5, Norchi said. "Those patients tend to bleed more. Our underlying mechanism of action being self-assembly should be relatively agnostic to somebody's coagulation cascade and bleeding tendencies." Kelly noted AC5's ease of use. "We are encouraged by how patients responded to the unique formulation of AC5 and how easy it was for a clinician to use," he said in the release.
Norchi echoed this sentiment. He pointed out that AC5 doesn't require cold storage and is simple to prepare, with the current formulation just requiring doctors to mix the powder with water and apply it using a syringe. "I recall doing some animal surgery once with a human surgeon." Norchi said. "She looked at me after using [AC5] for the very first time and said, 'This stuff is beautiful.' I think to use it is to really appreciate it." Arch Therapeutics anticipates that this study data will be published in a peer-reviewed journal and plans to use the data as part of its CE Mark application. That regulatory submission is slated at earliest by the end of 2016. As for plans in the United States, Norchi said the company tentatively intends to file an FDA submission in 2017, but cautioned that "submission is a coordination of a number of activities beyond just the clinical trial."
This study is just the beginning of the trials Arch Therapeutics plans to conduct. The company is focused on building a broad set of products, Norchi said, including an internal hemostatic device for surgical procedures, products for chronic cutaneous ulcers, prevention of surgical adhesions, and various form factors of its technology. "If a surgeon or health care provider sees bleeding, he or she can pick our product off the shelf. That's the goal," Norchi said. Marie Thibault is the managing editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter@medtechmarie.
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markm
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Post by markm on Aug 29, 2016 20:32:57 GMT
www.nuigalway.ie/about-us/news-and-events/news-archive/2016/august2016/curams-first-co-funded-clinical-trial-successfully-completed-with-arch-therapeutics-.htmlCÚRAMs First Co-Funded Clinical Trial Successfully Completed with Arch Therapeutics Wednesday, 24 August 2016 Professor Abhay Pandit, Director of CÚRAM, said: “Clinical trials are an essential component in creating medical devices that realise their full potential and ensuring the safety value of each new development. Without these trials, research cannot be translated into economic, health or societal benefits. Our collaboration with Arch Therapeutics is very exciting. Leaders within CÚRAM have a successful history working with Arch, and we are delighted to support their drive to commercialization for what should be very important products for the healthcare industry.”Here is Curam that is FUNDING $2 EUROS to ARCH's $1 EURO for human trials. Curam is backed by Irish government.
www.curamdevices.ie/
For me Curam has always been my third party due diligence to validate the Arch technology in addition to Dr. KSS. Look at background of people. Plus they have to put their own $$ behind the technology.
Arch AC5 -----A clear liquid that has been classified as a medical device--200+- applications Summary of Arch: www.archtherapeutics.blogspot.com/
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markm
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Post by markm on Sept 8, 2016 1:11:55 GMT
Arch CEO is a MD, MIT MBA and Former Portfolio Manager at Putnam $4 Billion Healthcare Fund.
Old but informative perspective on Norchi—the timing of trials off but at this time it matters little Arch has already now had its first successful human trial. www.youtube.com/watch?v=GRktlyx5ALk
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markm
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Post by markm on Sept 9, 2016 15:30:20 GMT
AC5 Topical Hemostatic Device achieves study endpoints September 08, 2016 By Bob Kronemyer The first clinical study of the AC5 Topical Hemostatic Device from Arch Therapeutics Inc. (Framingham, Mass.) for skin lesions with bleeding wounds was found safe throughout the surgical procedure and up to 30-days postoperatively. Performance as assessed by time to hemostasis was also 41% faster than standard care. “This hemostatic device is one of a set of products we are developing based on our self-assembling peptide technology,” says company president and CEO Terrence W. Norchi, M.D., in an interview with Cosmetic Surgery Times. “We believe these products have the potential to make a difference in patient care, leading to better outcomes while being a valuable tool in the surgeon’s or healthcare provider’s toolbox.”
Related: Silver shows promise in early wound treatment Dr. Norchi explains that when the hemostatic device’s self-assembling peptide is exposed to a highly charged environment, such as a wound or salt water, “the interactions among and between the peptide’s amino acid side chains and that environment lead the peptide to assemble into a physical mechanical barrier. You typically can see the liquid become more gel-like at that time. This is a very different mechanism of action compared to other successfully commercialized products and we believe it will help make a difference for patients.” The European 46-patient study included 10 patients who were on antiplatelet monotherapy. All patients had bleeding wounds from excision of at least two skin lesions under local anesthetic in the same setting. “The trial was designed to focus primarily on safety because this is very important both for us and for the regulatory authorities,” Dr. Norchi says. “In fact, especially in the European Union (EU), one can argue that showing safety matters even more than efficacy in order to be allowed to sell a product.” Arch Therapeutics expects to launch the AC5 Topical Hemostatic Device in Europe next year. “In the near future, we hope to see data that show hematoma and seroma formation is lessened,” Dr. Norchi says. “We further anticipate that tissues will heal normally, even in patients who have underlying diseases such as diabetes. Thus, if all goes well, the patient’s outcome will be improved with less bruising — which are both cosmetically and medically troubling — along with less scar formation and normal healing. That would be a wonderful outcome.”
Apart from hemostasis, potential applications for the technology include sealants and prevention of surgical adhesions, gastrointestinal bleeding (peptic ulcers) and bleeding from antithrombotic medications (blood thinners). Wound care applications are also promising, such as hard-to-heal ulcers (pressure ulcers and diabetic foot ulcers), plus specialty applications like central nervous system surgery, burn care and plastic surgery.
“Patients who are having biopsies or skin procedures that leave them prone to bruising, hematomas and seromas, could potentially benefit as well,” Dr. Norchi says. cosmeticsurgerytimes.modernmedicine.com/cosmetic-surgery-times/news/ac5-topical-hemostatic-device-achieves-study
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markm
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Post by markm on Sept 10, 2016 20:49:27 GMT
The Burden of Bleeding
Bleeding is common in both open and laparoscopic surgery and can result in 30-50% of procedure time spent controlling bleeding
Visual Surgery Field loss resulting in increased error risk
Increased length of hospital stay
Use of expensive resources (blood transfusions cost $500 to $ 1,000 unit)
Can result in abnormal healing and adhesions
Hematomas and seromas formation in surgery wounds
Antithrombotics (blood thinners) increase bleeding risk
"The clear field of vision (AC5 product is clear liquid) provided could cut procedure time in half as well as provide vastly increased likelihood of excellent outcome post-surgery."
Arch Therapuetic AC5 Surgical Hemostatic Device
Attributes of AC5
Synthetic peptide
Clear liquid, squirted or sprayed-- Can see and operate through it
Conforms to irregular wound geometry Physical mechanical barrier (no metabolic activity or chemical activity with the body)
Classified as Medical Device in Europe because of no interaction with the body No sign of interaction with human cell receptors or cell kinase enzymes
Stops bleeding promptly
Faster time to stop bleeding versus five different popular marketed products
Blood thinner agnostic—only hemostasis product that is.
Efficacy even in presence of “blood thinners” Bioasborbable
Natural amino acids, non-animal
Enables normal healing
Non-cytotoxic, non-pyrogenic, non-irritant, non-sensitizer
Stores at room temperature
Indefinite shelf life
Simple, effective, versatile, safe universal
Next Generation Medical Technology
There are many other hemostatic agents, but:
* They all rely on using the patient's blood,
*They all take minutes to stop bleeding, not seconds
* None of them create a clear seal that a surgeon can see through
* None of them work just as well on people on blood thinners
* None of them work in every situation where bleeding has to be stopped
Arch's AC5 product solves all these problems.
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Post by selluwud on Sept 10, 2016 22:46:44 GMT
The Burden of BleedingBleeding is common in both open and laparoscopic surgery and can result in 30-50% of procedure time spent controlling bleeding Visual Surgery Field loss resulting in increased error risk Increased length of hospital stay Use of expensive resources (blood transfusions cost $500 to $ 1,000 unit) Can result in abnormal healing and adhesions Hematomas and seromas formation in surgery wounds Antithrombotics (blood thinners) increase bleeding risk " The clear field of vision (AC5 product is clear liquid) provided could cut procedure time in half as well as provide vastly increased likelihood of excellent outcome post-surgery." Arch Therapuetic AC5 Surgical Hemostatic Device
Attributes of AC5
Synthetic peptide Clear liquid, squirted or sprayed-- Can see and operate through it Conforms to irregular wound geometry Physical mechanical barrier (no metabolic activity or chemical activity with the body) Classified as Medical Device in Europe because of no interaction with the body No sign of interaction with human cell receptors or cell kinase enzymes Stops bleeding promptly Faster time to stop bleeding versus five different popular marketed products Blood thinner agnostic—only hemostasis product that is. Efficacy even in presence of “blood thinners” Bioasborbable Natural amino acids, non-animal Enables normal healing Non-cytotoxic, non-pyrogenic, non-irritant, non-sensitizer Stores at room temperature Indefinite shelf life Simple, effective, versatile, safe universal Next Generation Medical Technology
There are many other hemostatic agents, but:
* They all rely on using the patient's blood,
*They all take minutes to stop bleeding, not seconds
* None of them create a clear seal that a surgeon can see through
* None of them work just as well on people on blood thinners
* None of them work in every situation where bleeding has to be stopped
Arch's AC5 product solves all these problems. Sounds like you're sold. Good luck
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markm
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Post by markm on Sept 13, 2016 0:51:05 GMT
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markm
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Post by markm on Sept 14, 2016 0:49:11 GMT
$400,000 ARCH monthly burn rate
$ 5.7 million cash 6/30/16 per quarterly 10Q + 1.9 million exercise of series E warrants by Maxim “investors” (I believe this happened in this third quarter) minus monthly operating expenses $ 1,200,000 for 3 months Equals $ 6.4 million or 16 months left—-my calculation
Need $ 8 to $12 million of additional capital for full Europe and USA clinicals per SEC docs (TINY) for ALL 200+- AC5 applications —-This amount is for EVERYTHING….
The human trials for Arch are not that expensive when compared to other biotech trials. Plus running human trials in Ireland is cheaper than most other places.
Remember that Curam is putting up 2/3 cost of Euro human trials—2/3 !!
So I have written about potential of Arch JV terms bringing in $$$$ to cover the entire $8 to $12 million
Future ARCH Financings
I am beginning to doubt whether there will be any future stock financings in light of what I am seeing in recent JV deals. SEE MEIP and ADXC Below
Study these and note size of numbers and dream about ARTH. Imagine if ARCH did a deal for just 50 of the 200 potential AC5 applications.
Remember we only need $ 8 to $ 12 million of additional capital to get all the human trials in Europe AND USA per SEC filings. A JV in Europe could take care of this easily.
Study these recent deals to see how big the numbers have gotten–HUGE:
Little MEI Pharma rockets up on $25M cash injection, deep-pocket partner for PhIII AML cancer study (market cap $ 67 million—royalty in high teens)
“This morning, MEI $MEIP is taking the wraps off a development deal with Switzerland’s Helsinn designed to shepherd the HDAC inhibitor pracinostat through a pivotal study. MEI gets $20 million in near-term cash —$15 million up front with a $5 million milestone at the start of the Phase III — along with a $5 million equity investment. And there’s $444 million in milestones on the table for success, along with royalties that can be earned from Helsinn’s marketing efforts”
“Advaxis Inc. ADXS, +5.48% shares spiked 28% in pre-market trade Tuesday after the company announced a $40 million agreement with Amgen Inc. AMGN, -0.15% to develop and commercialize cancer immunotherapy treatment ADXS-NEO. The agreement includes a $40 million upfront payment to Advaxis and a $25 million purchase of the company’s common stock by Amgen, along with sales milestone payments of up to $475 million and additional royalty payments based on global sales.
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markm
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Post by markm on Sept 16, 2016 16:58:37 GMT
"I believe AC5 is an obvious winner. It is very safe. It will be used in every operating room in the world, because it turns some of the messiest, most difficult surgeries into relatively blood-free procedures. It can dramatically reduce the need for blood transfusions in certain operations. It will be in every EMS vehicle to stop bleeding in accident victims immediately, instead of enduring a high-speed ambulance race against the death of a patient bleeding out. It will be in every soldier's pack for immediate use on the battlefield."
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