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Heddle is the ideal skipper for JBI. His floater dry-docks are ideal for keeping sinking rusty hulks above water just long enough to cut into pieces for sCrap. What could be more apropos?
LOL They would have to report that.
Only scam snake oil operations would maneuver to evade that requirement, capiche ?
there is a chance that potential future processors will be even more bloated as you point out, but I refer readers to the revenue skimming agreement where all the fun will be taken off the top of any workhorses. IE the costs are ours , the revenue is Capn's.
1) there is one indisputable common thread in JBII from first rumblings til today. And he is kind of cute in an ugly puppy sort of way.
2) The elephant is white. Thus Spake SeekingAlpha ? awww come on ......
3) at the deep down heart of every towering oak is that little inescapable acorn.
Its true the good ol days were rich pickings but the knock ons are still timely.
Extra credit) correct use of a word does not wear it out.
yup every comer Vice President of every successful company that generates plastic as an also ran is dying to get her career shelved by taking on a new building sized Goldberg that requires perpetual tinkerfarking to get into a money losing fuel business.
This is a Great Leap Forward with a cartoonish conclusion.
skimmin' millions across years of missed marks is thanks aplenty.
Maybe we can all just raise a toast of mañana bañana daiquiri,
at the drink-away-the-pain-support-group after BK.
No. Mid-month will see OB updated to the beginning of the previous month.
FDA still running their calendar like in the good ol hard copy days,
but going thru our money like a debutant on parade.
yeah next measure ride height. Oil2oil=equilibrium.
I say 5cent. Have it your way; DOWN>5%
ROTFP (rollin on the floor puke'n) just puke'n
how soon I forgot. True that. Still its all "A Goal" afa FDA cares
Follow volume my friend, not wet paint doggieshowponys.
It hit 40 a day ago and 45 a week ago.
Major volume panicked to 32.
I make that a 20~30% haircut. Sweet.
dont think of "down2cents", think as down >5% !
And the only important volume days recently were a huge spike of someone BAILING at a recent manufactured top,
and today now the rest are finally catching on & dumping this,
all day in a panicky hot potato slow walk to the fire escape.
Think of it as down 1/3 in 3 weeks.
Think of that ROFL'ing around
Jus rolf'in!
fun- OB is normal for this time of month. Updated monthly in arrears.
This week , as second full WW in month, ought to see an update.
Last month was 1 week late reportedly due to new FDA software glitch
The proper green nomenclutter is 'energetic disassembly' and we are covered.
There is a platter that will enter low orbit in those events.
Stock meltdown is not covered. Please file orderly toward the exits
True Dat. No external conspiracies anyway.
Now shill promoters, THAT I believe in.
Cap'n Heddle on deck and he only brought one life preserver.
Nownow, plenty chances for PatientInvestors Taking One for the Team coming soon. The latest whale dumper should drop support any moment now and bargins, BARGINS I say will be available for all .
yeah I took a little taste before the very positive CC.
Of course I made a total pig of myself across that triple bottom.
Starting to see how this thing works eh?
Wonder how its going elsewhere ROTMFFLMAO.
easy buying shares. Its selling whats the trick!
When has that ever stopped ?
GOOD GRIEF ! Link please to whomever said even once that "pyrolysis oil is worthless." ?
It's not worthless, it's simply worth less than the total costs of making it ! All the hype efforts the world has to offer can't change that.
Styrofoam is polystyrene, an aromatic hydrocarbon.
Un-compacted styrofaom is typically >95% air. Due to bulk, it's difficult and expensive to collect and transport.
Polystyrene shows up in insulation, packaging materials as well as food contact and injection-molded items (utensils, CD cases, etc). More than half of all polystyrene produced is blended with 5 to 10 percent butadiene rubber. Its often contaminated during use.
As a poor oxygen & water barrier, you can expect the closed styrofoam cells to transport significant amounts of either or both. Aren't those bad things to add to a pyro processor?
every time thats called a "scientific paper', I throw up a little in my mouth.
Its high schoolish
Trx = 5501, Nrx = 3003
the lowest bidder with a couple tape decks is not NASA's buddy & savior.
Something else to be curious about - if those tapes were the property of NASA, and NASA's information was on those, how does DJ Juicy, gaining access as a contractor, lay claim to any contents from there? I got to run that by some NASA buddies.
WIthout a receipt or a release, I suppose that indicates even the foundational so called technology of this company could be labled ill gotten.
I agree! Ricky is destined to be a big winner with the way the agreements are penned. Ordinary shareholders; meeeh not so much. Jus not'in!
is JBI even trading anymore ? How we gonna make butter if there is no churn ?
I guess its better than the 20% hair cuts headed out of the oven tic TOC.
I heard 1000 times $3 mill arrived in the coffers; well OK maybe it 333 times $1 million. Better shut the front AND back doors if we want to drip out the holes instead
19 Vascepa Patents in Orange Book. Did I lose count?
Is there already a new entry as BioB mentioned ?
Patent Data
N202057 001 8188146 Jan 27, 2020 Y Y
N202057 001 8293727 Feb 9, 2030 U - 1287
N202057 001 8293728 Feb 9, 2030 U - 1287
N202057 001 8298554 Apr 29, 2030 Y
N202057 001 8314086 Feb 9, 2030 U - 1287
N202057 001 8318715 Feb 9, 2030 U - 1287
N202057 001 8357677 Feb 9, 2030 U - 1287
N202057 001 8367652 Feb 9, 2030 U - 1287
N202057 001 8377920 Feb 9, 2030 U - 1287
N202057 001 8399446 Feb 9, 2030 U - 1287
N202057 001 8415335 Feb 9, 2030 U - 1287
N202057 001 8426399 Feb 9, 2030 U - 1287
N202057 001 8431560 Feb 9, 2030 U - 1287
N202057 001 8440650 Feb 9, 2030 U - 1287
N202057 001 8445003 Apr 29, 2030 U - 1287
N202057 001 8445013 Apr 29, 2030 U - 1287
N202057 001 8501225 Apr 29, 2030 U - 1287
N202057 001 8518929 Apr 29, 2030 U - 1287
N202057 001 8524698 Apr 29, 2030 U - 1287
Company response
MiMedx Addresses FDA Untitled Letter And Reiterates 2013 And 2014 Guidance
MARIETTA, Ga., Sept. 4, 2013 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, confirmed today that it is in receipt of an "Untitled Letter" from the Food and Drug Administration ("FDA"). The Company further announced that it expressly disagrees with the position in the letter and has been in conversation with the FDA to resolve the matter as quickly as possible. The letter questions the Company's Amnion / Chorion Injectable products' eligibility for marketing solely under Section 361 of the Public Health Service Act.
As explained on the FDA's website, an "Untitled Letter is an initial correspondence with regulated industry that cites violations that do not meet the threshold of regulatory significance for a Warning Letter."
Bill Taylor, the Company's President and COO, commented, "The Company was surprised by this letter considering the FDA conducted a directed inspection of our facility in July 2012, one of the express purposes of which was to 'determine the status of the [Company's] AmnioFix® injectable product.' The inspection report indicated that 'information regarding the [Company's] AmnioFix® Injectable product, which was rolled out August 2011, was collected and forwarded to CBER for review. The information collected included advertising, packaging, process procedures and studies conducted related to the product.' Following that inspection, the inspector advised us that CBER had completed its review and had no findings or further questions and, therefore, the inspection was classified as NAI, or No Action Indicated. The formal establishment inspection report confirming the NAI conclusion was issued on December 4, 2012." The establishment report is posted on the Company's website at www.mimedx.com.
MiMedx is very focused on regulatory compliance and proceeded with marketing the injectable product only after receiving advice from outside legal counsel that the product met the criteria for regulation as an HCT/P under Section 361 of the Public Health Service Act. The Company believes the FDA's conclusion is based on a misunderstanding of the micronization process and is responding to the Untitled Letter and will reiterate its request for a meeting with the FDA.
The Company reiterated its expected revenue range for 2013 of $54 million to $60 million and its 2014 goal of $90 million to $110 million. The revenues from the Company's injectable are projected to be approximately 15% of the Company's 2014 revenues.
Parker H. "Pete" Petit, the Company's Chairman & CEO, stated, "Based on other precedents, the Company believes it should be able to continue to sell its injectable products, but even if that not the case, management believes it can refocus its resources to achieve its stated revenue goals."
About the Company
MiMedx® is an integrated developer, manufacturer and marketer of patent protected regenerative biomaterial products and bioimplants processed from human amniotic membrane. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies include the device technologies HydroFix® and CollaFix™, and our tissue technologies, AmnioFix® and EpiFix®. Our tissue technologies are processed from human amniotic membrane that is derived from the donated placentas. Through our donor program, mothers delivering full-term Caesarean section births can elect in advance of delivery to donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary Purion® Process, to produce a safe, effective and minimally manipulated implant for homologous use. MiMedx® is the leading supplier of amniotic tissue, having supplied over 170,000 allografts to date to distributors and OEMs for application in the Wound Care, Surgical, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
Untitled letter per FDA
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm367184.htm
August 28, 2013
FACSIMILE & UPS EXPRESS MAIL
Bill Taylor, President and CEO
Surgical Biologics, a MiMedx Group Company
60 Chastain Center Blvd NW
Kennesaw, GA 30144
Dear Mr. Taylor:
During a Current Good Tissue Practice (CGTP) inspection of your firm, Surgical Biologics, a MiMedx Group Company, located at 60 Chastain Center Blvd. NW, Kennesaw, GA 30144, from July 30, 2012 to August 1, 2012, investigators from the Food and Drug Administration (FDA) collected information on the manufacture of a number of amniotic/chorionic-based products. This information was provided to the FDA’s Center for Biologics Evaluation and Research (CBER) for review.
You are currently registered with the FDA to recover, screen, package, process, store, label and distribute these products. You distribute some of these products directly as a MiMedx Group Company and act as a contract manufacturer for the other products. The FDA is contacting these other distributors under separate cover. These products include: AmnioFixTM Injectable, AccelShieldTM Injectable (Accel Spine), ---(b)(4)---------------------------------------, and EpiFixTMInjectable, all of which are intended for use, among other things, in reducing inflammation and scar tissue formation, as well as for enhancing wound healing of soft tissues.
These micronized amniotic/chorionic-based products are manufactured by ----(b)(4)------- dehydrated composite amnion and chorion tissue, and then having the end user resuspend them in normal saline for injection into soft tissues. Injectable amniotic/chorionic-based products are human cells, tissues, and cellular and tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d). However, these products are HCT/Ps that do not meet all of the criteria in 21 CFR 1271.10(a) and therefore are not regulated solely under section 361 of the Public Health Service Act (PHS Act) and the regulations in 21 CFR Part 1271. Specifically, the products do not meet the minimal manipulation criterion set forth in 21 CFR 1271.3(f)(1) due to the micronization process which alters the original relevant characteristics of the structural tissue, relating to the tissue’s utility for reconstruction, repair or replacement. As a result, your HCT/Ps are drugs as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)].
Please be advised that in order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations [21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312]. None of the amniotic/chorionic-based products described in this letter are the subject of an approved biologics license application (BLA), nor are there INDs in effect for any of these products. Based on this information, we have determined that your actions have violated the Act and the PHS Act.
This letter is not intended to be an all-inclusive review of the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and the PHS Act and their implementing regulations.
We request that you notify this office, in writing, of the steps you have taken or will take to address the violations noted above and to prevent their recurrence. Your response should be sent to me at the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Suite 200 N, Rockville Maryland 20852-1448.
If you have any questions regarding this matter, you may contact Dr. Jessica Kostick at (301) 827-6201. Please be advised that only written communications are considered official.
Sincerely,
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Running script chart added,
I believe you thank http://stocktwits.com/BullRunner, could be mistaken.
Suggest you save url in your own Faves in case of shennigans.
Now, about the reward for "suggestion of the day"
see signature for some AMRN appropriate music,
seems Stanley does as many things at once as Vascepa does..
Meant to before, I'll work on it.
Intro is a Mod Job, btw which more should apply for ...
No matter if anyone GTC 1 billion shares at infinity. Hypothecation prevention simply by out of the money GTC is an utter fallacy. And no I wont look a brokers credit dept for anyone. But then anyone daft enough to long JBI on margin is or will be destroyed anyway.
JBIs problem is not naked shorts ... its smartly dressed bears
JL Does that include Itiswhatitis ?
I feel that phrase is a plague ( a plaque?)
SunTrustRobinsonHumphrey starts AMRN at BUY, PT=15
http://www.streetinsider.com/New+Coverage/SunTrust+Robinson+Humphrey+Starts+Amarin+Corporation+%28AMRN%29+at+Buy/8656815.html
Sooooooooo pyrolysis is a net redux process ...