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Ah what a surprise.... Whole lot of nothing from McCoy. Few more enquiries in New Zealand over christmas, confirmed that all McCoy/RGIN/PMF has there is a whole bunch of pissed of people.
Has "no time" come and gone, its difficult to pin it down in RGIN time
Here you go Wag/Nip, as I said earlier Dont wait too long, read up on his tweets and by all means come over to here. Do your DD but this company is going places and making TONS of money in the process
https://twitter.com/IntVentures
https://investorshub.advfn.com/boards/board.aspx?board_id=29895
look at a 2 month chart for them, you'll see what the excitement is about
GLT RGIN, they're going to need it
Scott...yes, pls post the pR..thx
[quote he put out a very nice PR this morning then tweeted more PR's coming over the next 7-10 days][/quote]
Scott...put up the link to the pr twitter if you dont mind...thanks
Dont wait too long, he put out a very nice PR this morning then tweeted more PR's coming over the next 7-10 days. Theyve received 1 million in funding thus far with more waiting in the wings. Crypto's have put a lot of bread in my pocket where as RGIN, is looking like chopped meat
That sounds like a good move...I may do the same and revisit this at a later date.
Im not familiar with funding for cultured skin products, its kind of a newer market. 2 years is a long time to wait in penny land. Im taking my bread to a different party in Cryptoland, INTV to be exact. Their CEO communicates via Twitter and is doing very well by it. Doubled my money here but McCoy needs to find his tongue. Its buried in his neck somewhere.
Well what have I learned...How is it that McCoy cant find an investor for such a "Breakthrough" product? Shouldn't investors be chomping at the bit to get their money into this wonder product? Nicole...you are a complete fraud (I kinda thought that before) All your cheer leading is just a bunch of bull shite and you should just go away. I am going to hold my shares and see what the next two years bring waiting for funding.
If McCoy holds true to his pattern he'll release a 10Q detailing something of substance, then it'll be back to silence while he figures things out. His achievements and 2 months of someones cheerleading arent putting any benjamins in my pocket, it may be time to look elsewhere.
Scott, looks like we need a partner w/an amount of investment $$$ to get this on track. Considering the unmet need, what are chances of him getting hooked up w/such?
As I suspected,
https://ih.advfn.com/stock-market/USOTC/regenicin-inc-pc-RGIN/trades
actual sells are being logged as buys, so the green is sales the red is buys
folks are tired of the horse and pony show here. McCoy would be better off carving up that herd for Steaks
We'll see how the market views their "milestones" but without funding RGIN isnt moving much, regardless of whats been touted.
10K's out, next up a 10Q maybe a 8K then more silence?
10K is out
STILL LOOKING FOR MONEY TO MOVE FORWARD, BUT PROCEEDING ON THE WORK TO GET TRIALS STARTED.
Overview of key events of the year ended September 30, 2017
During 2016-17, the Company had been positioning its product, NovaDerm, to enter clinical trials to gain FDA product approval. Having secured Orphan Designation for NovaDerm, we completed the necessary independent research and executed several key supply and manufacturing contracts to pave the way toward a pre-IND meeting with the FDA. The IND is an investigational new drug application filed in order to receive permission from the FDA to enter into the clinical trial process. Our pre-IND meeting with the Agency was very successful and clearly defined some additional requirements we needed to begin the clinical trials and the agreed upon protocols we needed to perform the trials. It was further agreed that the trials would initially cover 3 patients and then would be extended to 7 additional patients. If approved, NovaDerm® will be the first and only autologous, cultured skin substitute product allowed for medical use on burns requiring grafting.
We estimated that the completion of the IND and the clinical trials would take approximately 12-18 months and cost in the range of $3.5 -$4.5 million. In addition to the completion of the IND, the only other significant gating item to entering the clinical trials is funding.
On December 26, 2016, Dr. Joseph Rubinfeld, one of the original Board Members, unexpectantly passed away. On August 7, 2017, Dr. Craig Eagle, also an original Board Member resigned to pursue other interests. The Company is grateful to these two gentlemen for their support and contributions during the past seven years.
These two board positions remain open anticipating requests of Board representation from potential investors.
The following is a review of the major milestones achieved during the year:
1. Our contract laboratory completed the laboratory portion of their analytical research services and we received their final report. This was a lengthy process in which we identified certain potential product improvements that we continue to evaluate internally. The final research report was a crucial part of our FDA submissions for an Orphan Designation and Pre-IND (Investigational New Drug).
2. We filed our annual report for our Orphan Designation, as a biologic, with the Office of Orphan Products Development of the FDA for the treatment of burns requiring skin grafting with NovaDerm®. The Orphan Designation granted is for “treatment of patients with deep-partial or full-thickness thermal burns requiring grafting”. The FDA's Orphan designation is granted to promote the development of unmet clinical needs with new therapies for rare diseases and disorders. Orphan Product terminology is applied to Orphan designated products proven safe and effective, and the approved Orphan Product entitles the product, up to seven years of US market exclusivity. In addition, there are other financial benefits along with the FDA’s support during the approval process.
3. We are following through on the results of our FDA pre-IND meeting. During the Pre-IND meeting The Agency addressed our questions and provided guidance on our planned NovaDerm® development pathway going forward. It was agreed that Bovine TYPE 1 hide collagen scaffolds from Pure Med Farma, LLC (a related company) would satisfy American Society of Testing and Materials testing to fulfill current ASTM Type I requirements. We are working closely with Pure Med Farma to ensure this testing complies.
4. We have continued to work on finalizing the IND as funds allow. An IND application is the document filed with the FDA to request permission to proceed with clinical trials. This application includes the candidate product's research, chemistry, manufacturing controls and processes, pre-clinical safety, clinical trial protocols, and more.
3
Table of Contents
Our Business Moving Forward In 2018
The company’s major objective for 2018 remains to secure the required funding to finalize some additional requirements of the IND application, and begin the clinical trials. It is estimated that the cost to finalize the IND will be approximately 1.5 million dollars, and the cost to complete Phase 1 of the clinical trial will be approximately 2 million dollars. As previously reported, our goal in obtaining this funding has been to minimize shareholders' dilution as much as possible. Consequently, we are primarily pursuing financing through the issuance of a debt instrument and international licensing agreements.
We have worked with a number of potential investors and continue to pursue the necessary funding based on our stated objectives. It has taken longer to raise the funds than originally estimated; however, we remain confident that our goal is achievable. In the interim, the officers and related parties intend to continue to fund the Company’s essential operating costs.
We have begun the preliminary planning for the clinical trials to the extent we are able, considering funding constraints. As previously reported, we have chosen a CRO to assist in our IND submission and conducting the trials. Clinical site selection and patient recruitment should be somewhat simpler than other clinical trials, as we are limited in site selection to the 150 burn centers qualified to treat catastrophic burns. In addition, the surgical protocol will be similar to the grafting procedures currently in use at those facilities. NovaDerm® should thus require minimal physician training.
The initial trials are planned to begin with a total of ten subjects with an Initial Data Safety Monitoring Board (DSMB) review of safety on the first three subjects once they have reached 6 months follow-up. We do not intend to interrupt our trial waiting for the DSMB report.
Our management is considering various possibilities and approaches to obtaining clinical trial materials and manufacturing. While no final decision has been made, management’s approach is to set up the trials so as to allow for a seamless transition into commercial production upon approval.
Regenicin's 10K is due this week, with a 10Q in Feb then a 8K about all of it in August if history repeats itself like McCoy has for the last 10 years.
https://www.otcmarkets.com/stock/RGIN/filings
Hahahahahaha Winthorpe! He has 10 business days to file from the NT without incurring SEC fines. A look at their history, McCoy has filed NT-10K's since inception, files, does a 8k announcement then goes back in to hybernation untill the following year.
Kind of sad actually but these companies dont make a dime off of the retail investor so updating us isnt their priority. We're just mushrooms.
When does Mccoy have to put the reports out by? I feel like Billy Ray and Louis waiting for the frozen orange juice reports to come in....
Lets see which it is:
1/ a real actual measure of concrete progress
2/ further promises
I know what I'm expecting but you never know.
Guaranteed Money Money Money Funding Coming Up
1 week left for McCoy to submit his 10K, then a 8K'd PR on development then its back to silence if he hasnt accomplished anything thats been touted.
I can park this dead money anywhere, crypto's and MJ stocks are hot!
Dead right. So the link you posted is to MoCoys consulting website. New Zealand Life Sciences Ltd is the NZ company McCoy is a shareholder in. So of course NZ Life Sciences maintains it's links to McCoy as he is a shareholder.
New Zealand Life Science Hikurangi LLC is a different company that owns the Hikurangi facility and fell out with McCoy big time. McCoy still claims on his website to be in partnership with them. And the NZ Life Sciences website still claims to have facilities and products in NZ, neither is true from what I've seen.
NZ has free public information on all companies at the link below. You can see for yourself that there is no common shareholder or anything else between these two companies. While you are at it, do some DD on McCoys other shareholders........
[url]
https://companies-register.companiesoffice.govt.nz/[/url][tag]insert-text-here[/tag]
For mine - this all fits the McCoy pattern, lots of noise and smoke, but nothing ever eventuates, and the closer you look the more dodgy things you can find.
United States Partner Companies
http://www.newzealandlifesciences.com/united-states-partner-companies.html
Usually when companies have a "falling out" with associates they REMOVE said associates from their websites,
what else you got
Here is some basic info. The site below takes you to the website of New Zealand Life Sciences Ltd, with Roy Nelson, Randall McCoy and others as shareholders. You will see that they say or imply strongly, that they have state of the art processing facilities in New Zealand. They don't, according to my sources.
insert-text-here
The Hikurangi facility is owned by New Zealand Life Sciences Hikurangi Ltd. This is unrelated to Randalls company, although McCoy in his own right, did apparently do some consulting for them before they fell out, and the falling out was major, no way back stuff. I think the photos shown are also used on Pure Med Farma website claiming to be from the USA facility.
On it's own - maybe not that big a deal. But over the 18 months I've been watching, it fits the pattern of claims being made that just aim at pushing up the RGIN price for a while, and nothing real ever eventuates.
Presumably you will ask Randalls alter ego on here to prove her positions as well?
These are the people and plant at Hikurangi that fell out with McCoy, and my understanding - on good authority - is that McCoy was doing some consulting only, not associated with RGIN. He now has nothing to do with these people or this plant, and never had any ownership of it. The news article is about 6 months old, and has been well overtaken by events.
This needs some follow up;
http://www.maoritelevision.com/news/regional/northland-plant-change-collagen-market
It’s Going To Be A Great 2018 Huge Things Are Happening As We Speak
Yep, agree with most of that except they don't have their own Alabama facility. They did get some closed herd hides processed down there somewhere, but the hows/wheres and who has been paid or not are the subject of ongoing rumours. Seems to fit the pattern of claims being made that end up being hollow, to put it politely.
There are so many moving parts.
- McCoy consulting firm
- PureMed
- Life Sciences
- RGIN
Now everyone in RGIN is on PM's board. Nelson runs PM. They have the only FDA APPROVED facility in US. They are the main distributor on LS product. So if falling out with McCoy that's not end of the world at all. They have own producing facility in Alabama. Besides there are many more farms moving to collagen as way more profitable, so LS not only game in town.
Its about getting financing and into trials. There are many more people involved then just RGIN employees. Its just that stock will get the benefit
What they were looking to accomplish in 2017:
Obviously Late: But this next report is VERY IMPORTANT
• Secure interim financing to finalize product development needed to support the IND;
• Complete a second round of financing in order to conduct 10 patient clinical trials with NovaDerm® and finalize required manufacturing engineering runs and validations;
• Work with Pure Med Farma to finalize Collagen Scaffold Testing Specifications for NovaDerm®;
• Finalize contracts with the CRO and select the NovaDerm® clinical trial material manufacturer;
• Retain a Principal lead investigator, medical advisor, surgical trainer and dermopathologist;
• Select and execute contracts with two clinical study sites; and
• Perform a successful graft of NovaDerm onto a clinical trial subject.
Had a little more info from NZ, - the guys who booted McCoy are going OK and it is their facility at Hikurangi - this facility has nothing to do with McCoy who only did some consulting for them before falling out with them. He seems to still be claiming that it is his facility, on the NZ website he is using. I've been following this for 18 months, and the same thing keeps happening, delays and obfuscation. The ties with Discala defendants is also a big worry, Kyleen Kane/Cane etc. I'm still hoping there is a good product here somewhere but am increasingly dubious.
Thx...I am reading it as positive also...2 wks is good w/me
Typically NT's have 2 weeks to file before incurring fines. since the 10K is Wayyyyyyyy overdue by a year, McCoy will be fined by the SEC another hiccup in this companies history, but its a sign of....progress?
The subject annual report, semi-annual report, transition report on Form 10-K, Form 20-F, 11-K or Form N- SAR, or portion thereof will be filed on or before the fifteenth calendar day following the prescribed due date; or the subject quarterly report or transition report on Form 10-Q, or portion thereof will be filed on or before the fifteenth calendar day following the prescribed due date; and
Anyone see the extension date? New due date ...IS _______?
Extension granted...
https://ih.advfn.com/p.php?pid=nmona&article=76380132
a trickle of volume. McCoy hasnt deployed his Load up Load Up Load uP helper lately
You must be kidding.
This stock is opening some eyes...
https://finnewsweek.com/reversal-time-regenicin-inc-rgin-schaff-indicator-nearing-key-levels/666471/
I'm good thanks anyways
Want to buy my shares?
Huh, over the past year or so we have periods of no trade days so the recent activity seemed an improvement. No info available on product/FDA position or any trials. TBD.
My take is this...for the last three to four weeks, it looks to me like the price is being floated in a particular range that is set. It is now .105-.1299. A few weeks ago I commented in was ranging at .086-.09. So there is a constant ask and bid at those numbers. The volume has obviously increased so I look at it not so much from price but the volume. Why is this happening? Is it good or bad? I really do not know. It seems to me someone or people are going through the trouble of keeping this range there has to be a reason. I think they do not want it shorted so thats why this is happening. The lack of news bothers me as well...I think its still a wait and see till after the new year. Let me qualify all this by saying Im just a novice investor looking at this like a puzzle and trying to figure it out. But the trends of what Im talking about are all there.
From a technical setup, its not the best indicators. Somethings not right here imo.
Any thoughts on recent price/volume activities?
Santa McCoy needs a new GPS cause he missed the bullzeye this year. Maybe he's on New Zealand time?
According to you, lol and youre who 2 days old?
If true, that's insider information and posted and recorded on a public blog. Cant be taken back. Wow ... How wreckless...
I'm pretty cautious about the so called good news in NZ. My info is that although the NZ Life sciences (McCoy and his buddies) implies they own or control a facility at Hikurangi, my info is that they don't, and fell out big time with the folks that do own it. Pretty misleading to still be claiming they are involved with it if true. Not much of what they are claiming for NZ checks out, specially if it's correct that the media done earlier in the year is with the guys that ended up booting them.
Jessie, great info. Thanks buddy...keep us all posted on what you are seeing or thinking. Your input is greatly appreciated.
No one really knows where this will go. I see it in stages which is way better than a huge pop, everyone sells and shorts then goes back to no trading volume. So for news:
1. Lets see what funding is: Do they dilute stock when receive funding, that's a biggie, or is it a big loan, or is it giving some of company away. So watch that.
2. How long will FDA approval take: Is it a 1 yr process or 2 year process. If its long then guys may wait to buy it, if shorter than buyers will hold.
Institutions cant buy until above $5, so I hope don't split stock, so they can buy it, that's bad because will probably hammer it and short it.
Clarity on the consulting company
How will news be discussed during trials. If we wait with no news again, then at end they say approved or not, that is not good.
If approved will probably be bought out just like many of the other companies I have stated in this space.
These guys have been trying to get this to market since bought the technology in 2010, as I was an initial investor at .62. Averaged down a lot and still hold, it just seemed to take forever, but if done right, that's a good thing.
Also, there are many articles on the consulting company. life Sciences and other stories on the NZ collagen market. The entire market for all this is roughly $118B. So plenty to share. Great article last May how the entire region is looking to do this because way more profitable than farming. Type in McCoy or Life Sciences, or NZ closed herd, you will see they have been busy all year. Probably buy dips until news, cant really lose much at this cheap price.
Great insight Jesse. What do you think the end game is for this stock. Lets assume they get into clinical sooner than later and they ultimately get fda approval. Where do you see this thing going?
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Regenicin, Inc.
10 High Court
Little Falls, NJ 07424
**updated and correct phone number** (973) 557-8914
they filed this on aug 22 2016- http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=11558959
Name: | Randall McCoy |
Title: | Principal Executive Officer and Director |
Date: | August 22, 2016 |
Name: | John J. Weber |
Title: | Principal Financial Officer and Director |
Date: | August 22, 2016 |
LITTLE FALLS, N.J., June 12, 2012 /PRNewswire/ -- Regenicin, Inc. (OTC Bulletin Board: RGIN) a biotechnology company specializing in the development of and commercialization of regenerative cell therapies to restore the health of damaged tissues and organs, announced today that the Food and Drug Administration (FDA) has granted Orphan Status approval for the PermaDerm® product, the only tissue-engineered skin prepared from autologous (patient's own) skin cells consisting of both epidermal and dermal layers, that is indicated for catastrophic burn patients. The FDA had previously designated PermaDerm® to be a biological/drug (permanent skin replacement) not a medical device (temporary skin replacement). PermaDerm® is the only skin replacement technology to receive this Biological/drug designation.
COMPANY HIGHLIGHTS:
PermaDerm™ is being developed to be the only tissue-engineered skin prepared from autologous (patient's own) skin cells consisting of both epidermal and dermal layers. A small harvested section of the patient's own skin can be grown to graft an area one hundred times its size in as little as thirty days.
These living, self-to-self skin graft tissue are intended to form permanent skin tissue that will not be rejected by the immune system of the patient, a critical possibility in porcine or cadaver skin grafts used today.
The technology has been clinically tested in over 150 pediatric, catastrophic burn patients. Currently Regenicin is working with its contract manufacturer to prepare for pre-market approval of PermaDerm™ from the FDA.
PermaDerm™ is being designed to save lives, reduce healthcare costs by decreasing the patient's stay in the Critical Care Unit and reduce the need for additional surgeries. An insurance company procedural code has been approved for reimbursement of costs to hospitals. The American Medical Association has assigned CPT (Current Procedural Terminology) code for cultured skin substitutes under the dermal substitute category which enables insurance companies to process and hospitals to be reimbursed for cultured skin substitutes once approved by the FDA.
According to the American Burn Association, there are currently over 2,000 cases annually involving burns covering over 50% of the patient's total body surface area.
PermaDerm™ is being developed for the treatment of catastrophic, full-thickness burns covering over 50% of the total body surface area.
PermaDerm™ has been used in clinical trials on pediatric patients with catastrophic burns covering from 50 to 90+% of their body.
PermaDerm™ is being developed to require less donor skin from the patient's own body, thus needing fewer surgeries to harvest skin. The result is expected to be less scarring, with fewer infections and faster healing.
Randall McCoy
Chief Executive Officer
Randall McCoy has more than 37 years of experience in the healthcare industry. His experience includes executive positions and scientific research and development. His previous employment includes George Washington University, Temple University Medical School and RCA/SRI International (Director of Life Sciences and Electronic Displays). Mr. McCoy has assisted both small and major pharmaceutical/device companies address FDA issues. He has also helped over 225 foreign and domestic companies introduce their FDA regulated drug and medical device products into the US and World market. Mr. McCoy currently has over 30 Patents US and International.
Changed to AMBS
Dr. Joseph Rubinfeld Ph.D
Director at CytRX; Initial Co-Founder of Amgen, Inc.
Dr. Joseph Rubinfeld co-founded SuperGen, Inc. in 1991 and has served as its Chief Executive Officer and President, Chief Scientific Officer and as a director. He has been a director of CytRX since July 2002. Dr. Rubinfeld is also a founder of JJ Pharma. Dr. Rubinfeld was one of the four initial founders of Amgen, Inc. in 1980 and served as a Vice President and its Chief of Operations until 1983. From 1987 until 1990, Dr. Rubinfeld was a Senior Director at Cetus Corporation and from 1968 to 1980, Dr. Rubinfeld was employed at Bristol-Myers Company. Dr. Rubinfeld received a B.S. degree in chemistry from C.C.N.Y. and an M.A. and Ph.D in chemistry from Columbia University.
John Weber
Regenicin™'s Interim CFO
John Weber most recently served as Executive Vice President of Fujifilm USA, the highest ranked American corporate officer, from 2006 until his departure in 2009. His responsibilities included overseeing all corporate activity with the exception of R&D. During that time Fujifilm was ranked as the fastest growing medical imaging company, consistently ranking #1 or #2 in customer satisfaction. From 1998 through 2006 he served as Senior Vice President, Operations at Fujifilm USA where he spearheaded the transition of the company from a film distributor to a digital medical informatics company. From 1986 until 1998 he served as CFO where he helped to profitably manage Fuji's growth from an employee base of 75 to over 1,000. Prior to his distinguished career at Fujifilm USA, Mr. Weber served as the CFO for the confectionary and drinks division of Cadbury Schweppes Limited for three years and as Corporate Controller for an additional five years.
Dr. Craig Eagle
Pfizer Oncology
Dr. Craig Eagle joined Pfizer Australia in 2001 as part of the medical group. In Australia, his role involved leading and participating in scientific research, regulatory and pricing & re-imbursement negotiations for compounds in therapeutic areas including oncology, anti-infectives, respiratory, arthritis and pain management. In 2003, Pfizer relocated Dr. Eagle to the United States where he was appointed as the worldwide lead for development of Celecoxib in oncology to oversee the global research program. Since that time he has had increasing responsibility for overseeing the global research plans and teams for Irinotecan and Dalteparin. In 2007, he became head of Medical Affairs and Outcomes Research for Pfizer, including the US oncology business. Dr. Eagle has led, or been directly involved with, teams that resulted in eight new products or indications. As part of his current role at Pfizer, he has led the integration of the Pfizer/Wyeth oncology businesses and portfolio.
The Broadsmoore Group, LLC 9,223,770(8)
560 Lexington Ave., 16 th Fl.
New York, NY 10022
PDA Associates LLC 7,770,000(9)
560 Lexington Ave., 16 th Fl.
New York, NY 10022
Officers, directors and 5 percent shareholders collectively 54,508,099(10) 59.74%
* Less than 1%
(1) Unless otherwise indicated, each person or entity named in the table has sole voting power and investment power (or shares that power with that person's spouse) with respect to all shares of common stock listed as owned by that person or entity.
(2) A total of 83,807,964 shares of the Company's common stock are considered to be outstanding pursuant to Rule 13d-3(d)(1) under the Securities Exchange Act of 1934.
(3) Includes 32,821,641 shares of common stock held in his name and options to purchase 885,672 shares of common stock.
(4) Includes 50,000 shares of common stock held in his name and options to purchase 885,672 shares of common stock,
(5) Includes 1,050,000 shares of common stock held in his name and options to purchase 885,672 shares of common stock
(6) Includes 50,000 shares of common stock held in his name and options to purchase 885,672 shares of common stock,
(7) Includes 33,971,641 shares of common stock, options to purchase 3,542,688 shares of common stock and shares of Series A Convertible Preferred Stock convertible into 3,350,000 shares of common stock,
(8) Includes 5,706,270 shares of common stock held in its name, warrants to purchase 167,500 shares of common stock and shares of Series A Convertible Preferred Stock convertible into 3,350,000 shares of common stock,
(9) Includes 7,400,000 shares of common stock held in its name and warrants to purchase 370,000 shares of common stock,
(10) Includes 47,077,911 shares of common stock, warrants to purchase 537,500 shares of common stock, options to purchase 3,542,688 shares of common stock and shares of Series A Convertible Preferred Stock convertible into 3,350,000 shares of common stock
http://ih.advfn.com/p.php?pid=nmona&article=5144097
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