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I appreciate your interest.
But I have nothing further to add. I've explained it plenty enough, go back and read my explanations or don't. Believe it or don't. Rexista will not get Full Approval until OxyContin's exclusivity is expired. It could get a carved out label but I doubt it. I told you they would not get Priority Review and why and in fact they did not. When we're still here in late 2018 or early 2019 without an approval, maybe then you'll get it. Either way, no skin off my back. GLTY.
I've told you this multiple times before.
WeeZuhl, you interpreting Oxycontin's FDA Exclusivity wrong. It is only for NPP or New Patient Population. You are thinking it is like New Chemical Entity or New Product exclusivity where it completely blocks any other similar drug from approval.
As I mentioned before the FDA has removed the nasal exclusivity which expired in 2016. So the "NPP" is the only one left. Also, I do not think a successful Paragraph IV patent challenge can get around the "NPP" exclusivity. The "NPP" FDA exclusivity is non-patent exclusivity and not related to patents. So you are wrong on that too.
Aren't you soffering of the "I-am-the-truth bias"?
You keep thinking that...
You were wrong when you thought that the NPP exclusivity was pediatric exclusivity and extended the nasal exclusivity for 3 years.
its important to actually listen and read when they put on these conferences to what is said and how they say it
Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, stated, "FDA approval of our application for a generic version of Glucophage® XR provides further indication that the FDA is making progress to clear its backlog of ANDA drug candidates under review, and further validation of our core drug development and regulatory capability. We are encouraged that some of the Company's other 8 ANDA candidates may be accorded further attention soon. We are actively evaluating options to realize commercial returns from this new approval."
Generex & Emmaus: A Love Story
Gnbt is broke. They cant dilute enough to come up with the money needed to pay Emmaus. How is this deal going to get done.
Now a question. The way I read the letter of intent with Emmaus is that you’re treating GMBT as a company that has currently a market value of about 10 million US dollars, or 12 million. I’ve already once sent an email to you, which I never received a reply to. I see a significant hidden value related to GMBT, sorry related to _____ [0:54:42] and as well as related to Antigen Express, which is not reflected in the current stock price and with this, the way you’re trying to do this acquisition, you’re giving away 90 per cent of that value for free to the current owners of Emmaus. I would really like to receive a comment on that and how you would like to re-compensate the
current stock holders. I’m following this company for 10 years now and I’m actually very upset as you may hear out of my words.
Joe Moscato:
Let me just say one thing as regard to your first question. As far as the value of the platforms, we believe there is significant value in our platforms and we will come back to those platforms in a more efficient and more effective way with this team.
As far as giving away 90 per cent of our company to Emmaus, well there are significant further steps that need to be done. And those steps, obviously _____ [0:54:00] the reverse stock split. Once that reverse stock split is garnered then we will move immediately for an annual meeting of shareholders. We will ask for new authorized capital which will reduce the Emmaus holdings and that stock that Emmaus gets out of the transaction is given after the new authorized capital is approved by shareholders. So, if we authorize 500 million shares, as an example only, and the stock is $10 a share, the math would call for Emmaus owning less than 10 per cent of the company. It’s all about what the ratios will be, it’s all about how much authorized capital we get approved from shareholders after the reverse as we move into the annual meeting. Again, we’re not giving any of our stock to Emmaus until after that is accomplished. The ownership of Emmaus will significantly lessen in terms the way the cap structure is laid out today.
This is correct.
Blue dye mixed with Oxycodone, time-released. So maybe blue dye is also time-released over 12 hours similarly to the Oxycodone. If dye is released over many hours, maybe it will not even change the color of poop.
The PODRAS patent summarizes the procedure to manufacture the pill. It says the ingredients of the core, which contain Oxycodone and the blue dye, are mixed together into granules. The core also contains the ingredients for time-release.
Such a clever analogy.
All the smarties and m&m eating kiddies with blue dye smeared all over their cute little faces aren't turning into little blue smurfs and dying
Each blue m&m contains .08mg blue #1, so an individual would need to eat 377 blue m&m's per day every day to achieve a similar blue dye load in the their gut as a Rexista user.
I guess he decided it is not sequestered.
Della Penna replied to my email about the blue dye and said that it is an Inactive ingredient.
When any color dye is used to make a tablet look more appealing, that is an inactive ingredient, a general use color additive. For "stigmatizing dye," which deeply discolors human tissue, there is an intended effect on the user, and it causes a change to the user. So it meets the definition of active ingredient no matter how you slice it. But even if you want to call it an inactive ingredient for some strange reason, you still have to recognize that it is a bioactive molecule. It has biological activity that can be studied in vitro and described. In the correct human body compartment (blood) at the necessary dose (unknown) in a particular situation (sepsis), it has a very well-described biological effect (death).
Blue dye no. 1, a triphenylmethane dye, is a potent inhibitor of mitochondrial respiration in vitro and reduces oxygen consumption by a factor of eight in mitochondrial preparations in vitro. It appears to inhibit energy transformation by blocking the adenine nucleotide translocator (as is the case with atractyloside).
LPC does not hold (m)any shares.
There is a limit in the number of shares that Lincoln can hold. They can't hold more than 9.99% of the outstanding shares at any given time. Based on the numbers in the 10Q they have exceeded the limit!
Lincoln Park Capital are not longs.
Obviously, these kinds of financing organizations do not generally discuss their business model, but the way they make their money is not hard to figure out. It basically involves churning most of the shares as they get them. If they keep any for long-term, it's probably not very many, and maybe only (some of) the free shares they get to initiate the deal.
This is one classy company.
http://www.abnnewswire.net/press/en/87070/
IntelliPharmaCeutics International, Inc. (NASDAQ:IPCI) Abuse Deterrent Technology featured at Healthcare Conference
NetworkNewsWireNew York, New York, 08:30 EST Feb 17, 2017 (NetworkNewsWire) – The ‘2017 Disruptive Growth & Healthcare Conference’, which ran February 15-16 at the Convene at 730 Third Avenue Conference Center in midtown Manhattan, New York, featured some stellar participants, either as presenters or as sponsors. Along with over 60 other firms in a variety of fields related to biotech, IntelliPharmaCeutics International, Inc. (NASDAQ:IPCI) (TSE:I) was on the bill. The Toronto, Ontario-based company was scheduled to introduce its drug delivery technologies and exhibit its leading pipeline candidates.
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Yes! Yes! Yes!
I think blue dye is not normally digested and turns poop blue anyways. Like when you eat a bunch of Fruit Loops, the food coloring makes your poop colorful.
but until that time, be forewarned. I will make sure every time you post regarding this blue dye, I will counter with a post that states" the company claims no blue dye is released unless the drug is tampered with
Good to know...
it makes perfect sense. they created an encapsulate of the blue dye that wont be digestible however it will break apart if tampered with. They indicated all along they can use numerous items and deliver numerous items in one pill using nPODDDS.
The burden of proof isn't on me. I asked you to provide evidence of your claim which you haven't. If one were reading their patents one would have surely seen evidence of separation layers within delivery mechanisms and numerous mentions of methods of controlling the release of 1 or more substances within a capsule/tablet. So where is your evidence to support your claim
Nailed it!
Despicable_Z wrote:
Please...just go...away...for good.
Your whole point is the blue dye will be released into the GI tract causing all kinds of deadly issues. BUT you have not offered any evidence the blue dye is delivered into the GI tract at any point when used as directed.
So ...... where is your scientific evidence of this delivery ?
And what if the FDA doesn't like it ? It gets removed from the formulation. That's just terrible isn't it.
Can you provide other examples?
the dye IPCI is using falls under the FDA's GRAS (generally recognized as safe) section, and as such, there shouldn't be any safety issues.
...the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use
Those must be some fat kids.
lmfao tell that tale of complete and utter rubbish to the millions of kids who've been eating blue smarties and m&m's for decades while smearing FDA approved blue dye #1 all over their tiny hands and cute little faces hahahahahahahahaha weeeeeeeeeeeeeeeeeeeeeeeeeee
More fun with math: Each blue m&m contains .08mg blue #1, so an individual would need to eat 377 blue m&m's per day every day to achieve a similar blue dye load in the their gut as a Rexista user.
The company has now publicly stated how this will work.
Unless you tamper with the drug no blue dye will be released. It will stay encapsulated. all you will do is poo out little blue pellets. LOL
again, your not addressing the issue. "No blue dye will be released unless the product is tampered with"
I do not believe the FDA worries about people who tamper with drugs and trying to hold the company liable.
I wonder what Weasel will bring today?
Blue Colon at Autopsy
Arch Pathol Lab Med—Vol 125, May 2001
The autopsy was performed on a 50-
year-old diabetic woman who was
status postnephrectomy for xanthogranulomatous
pyelonephritis. She
had been in the surgical intensive
care unit for 34 days prior to her
death. During this time she received
enteral feeding by the aspiration detection
protocol calling for 0.5 mL of
blue food color per 250 mL of food
given. The active ingredient in this
product is FD&C Blue No. 1 (Warner-Jenkinson,
St Louis, Mich), also
commonly known as ‘‘brilliant
blue.’’ This patient had a similarly
colored bright blue colon and some
less intensely stained patchy blue areas
in the small intestine.
While Podras has not been proven yet, nPODDDs has been. I think its this delivery system that made Focalin a success.
So,clearly these little spheres that encapsulate the active ingredients can be made out of different substances. The one containing the blue dye just wont dissolve and will be easily passed through your bowels.
Example 29
Oxycodone Sustained Action (SA) 80 mg ODR Tablets (Each Tablet Contain 70 mg in the Core and 10 mg External to the Core) Formula for core
Ingredients % w/w
Oxycodone HCl 18.34
Polyethylene Oxide 65.00
Aluminum lake Blue#1 4.00
Crospovidone 2.00
Microcrystalline cellulose 11.66
Eudragit RL 2.00
Magnesium stearate 0.50
however, if you break apart the pill by crushing then they break apart and would release the dye! pretty clever!
fully explains now why dye isnt an issue. it never gets into your system unless you abuse the drug.
Oh well if the CFO says so...
Blue dye issues put to rest......did anyone else listen to the presentation? Penna clearly said the Blue dye is only released IF someone uses the drug against directions by crushing it. so by mere ingestion the blue dye isn't released.
Not sure the FDA requires a safety test for using the drug in another means than how it was intended LOL. as long as you dont abuse it, no dye released!
Both your math and your logic are off.
great so each pill weighs what .5g tops? Probably less but for simplicity sake for yourself. The dye makes up 4% of that weight. So .02g of weight is blue dye. So TOPS 20 mg of blue dye.
WHO says a ADI of 12.5mg/kg so average male in US 195 lbs (88 kg) 88x12.5mg = 1100mg so you'd have to eat over 55 pills to reach that level? Even an addict wouldn't smash 55 pills to hit that level. Which is not even toxic. What prescription would ever call for that?
Example 29
Oxycodone Sustained Action (SA) 80 mg ODR Tablets (Each Tablet Contain 70 mg in the Core and 10 mg External to the Core) Formula for core
Ingredients % w/w
Oxycodone HCl 18.34
Polyethylene Oxide 65.00
Aluminum lake Blue#1 4.00
Crospovidone 2.00
Microcrystalline cellulose 11.66
Eudragit RL 2.00
Magnesium stearate 0.50
FD&C blue dye no. 1 was approved by the FDA for use in food after experiments showed that the dye was nontoxic and was not absorbable. However, these experiments were performed in healthy animals.
We encourage judicious use of this food dye in patients with sepsis or other illnesses associated with increased gastrointestinal permeability.
Of course I know. Thanks again.
mopar44o wrote:
So do you know specifically what blue dye IPCI is using? Are they using a natural dye? An artificial dye? There are several of them. The fact is you know nothing at all.
Example 29
Oxycodone Sustained Action (SA) 80 mg ODR Tablets (Each Tablet Contain 70 mg in the Core and 10 mg External to the Core)
Formula for core
Ingredients % w/w
Oxycodone HCl 18.34
Polyethylene Oxide 65.00
Aluminum lake Blue#1 4.00
Crospovidone 2.00
Microcrystalline cellulose 11.66
Eudragit RL 2.00
Magnesium stearate 0.50
Formula for Loading Dose
Ingredients % w/w
Opadry White 13.09
Oxycodone HCl 9.53
Water 77.38
Formula for Acid labile coat
Ingredients % w/w
Eudragit E (milled) 9.73
Sodium Lauryl sulfate 0.974
Stearic acid (milled) 1.46
Talc 3.40
Simethicone 0.84
Water QS
Formula for Alkalinizing Coat
Ingredients % w/w
Opadry White 16.132
Magnesium Hydroxide
It just shouldn't be this easy.
Doog- I heard the FDA is considering that M&Ms carry a warning label that excessive use of said product may cause sepsis and subsequent death! Bahahahah!!!!!
The Quest to Make a True Blue M&M
By MALIA WOLLAN
OCT. 5, 2016
In response to growing pressure from consumers across the globe, Mars announced in February that over the next five years it would remove artificial colors from all the processed foods it makes for human consumption, and that pigments found in natural substances would take their place. This research kitchen is where scientists are now cautiously tinkering with the chemistry of some of America’s most celebrated candies.
Mars has joined a growing list of global food manufacturers removing artificial dyes from some or all of their products. The companies include Nestlé USA, General Mills, Kraft, Frito-Lay, Campbell’s, Kellogg’s and Mondelez International (the maker of Oreos, Tang and Sour Patch Kids). The orange glow of Kraft’s revamped macaroni and cheese now comes from paprika, turmeric and annatto, a coloring extracted from tree seeds. General Mills experimented with 69 different natural dyes before it released a naturally colored Trix and six other reconfigured cereals in January. (The company was unable to find a workable blue or green, so those colors have been left out for now.)
In 2013, the Food and Drug Administration approved Mars’s petition to use the microscopic algae spirulina to make the first natural blue dye approved for use in the United States. As a result, any food manufacturer in the country can legally use spirulina as a colorant. Mars spent years researching spirulina’s safety; in order to overhaul 1,700 or so recipes and update its global manufacturing capabilities, the company desperately needs a substitute for synthetic Blue No. 1, as does the rest of the industry. But right now, there isn’t nearly enough spirulina dye to go around — and in any case, sometimes it doesn’t yield just the right blue, or the color degrades and comes out blotchy, or it tastes odd. So researchers are still looking everywhere for other natural blue pigments.
There are things we still don’t know about how artificial colors interact with the human body. Research shows that Blue No. 1 is the only dye that crosses the blood-brain barrier, which exists to protect the brain from toxins and pathogens. It enters the fluid inside the skull, but scientists know almost nothing about what it does once it’s there. Rather than continue to defend themselves against these growing concerns, big food companies last year began making public commitments to give up synthetic dyes.
This is way too easy.
He's ridiculous.. Blue dye #1 was used in Smarties for years. Never heard of anyone die from eating blue smarties.
In 2006 it was announced that Nestlé were removing all artificial colourings from Smarties in the United Kingdom, owing to consumer concerns about the effect of chemical dyes on children's health.[10] Nestlé decided to replace all synthetic dyes with natural ones, but, unable to source a natural blue dye, removed blue Smarties from circulation (which led to the common misbelief that blue Smarties triggered hyperactivity in some children) and replaced them with white ones.[11] White Smarties were replaced by blue Smarties in the United Kingdom in February 2008, using a natural blue dye derived from the cyanobacterium spirulina.[12]
Artificial colouring was removed from Smarties on the Canadian market in March 2009. The new range included all the colours except blue. Blue Smarties were re-added in May 2010.[13]
Huh?
I don't think you got it right at all. The purpose of the blue dye was to flag signs of abuse as a early warning. It was never designed to prevent chewing.
Our RexistaTM formulation contains a blue dye that is emitted once the tablet is tampered with or crushed, and may act as a deterrent to a user who attempts to abuse it orally or via the intra-nasal route.
I didn't realize the Commissioner was involved...
weasel....its still covered under this;
Quote:
(2) If an application for a new drug inferentially contains a proposal for a color additive regulation, and the applicant fails to designate it as such, the Commissioner, upon determining that the application includes a proposal for a color additive regulation, shall so notify the applicant and shall thereafter proceed in accordance with the regulations in part 71 of this chapter.
so your telling me, the IND as well as pre-submission meetings and acceptance review meeting no one has applied this section to see if they complied?
This is so easy.
weasel.....read this and tell me why Blue dye can't be used as long as its certified?
Quote:
§74.1101 FD&C Blue No. 1
(a) Identity. (1) For ingested drugs, the color additive FD&C Blue No. 1 shall conform in identity to the requirements of §74.101(a)(1).
(2) For externally applied drugs, the color additive FD&C Blue No. 1 shall conform in identity to the requirements of §74.2101(a).
(3) Color additive mixtures for drug use made with FD&C Blue No. 1 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring drugs.
(b) Specifications. (1) The color additive FD&C Blue No. 1 for use in coloring drugs generally shall conform in specifications to the requirements of §74.101(b).
(2) FD&C Blue No. 1 Aluminum Lake shall be prepared in accordance with the requirements of §82.51 of this chapter.
(c) Uses and restrictions. (1) FD&C Blue No. 1 may be safely used for coloring drugs, including drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice.
(2) FD&C Blue No. 1 Aluminum Lake may be safely used for coloring drugs intended for use in the area of the eye, in amounts consistent with current good manufacturing practice, subject to the restrictions on the use of color additives in §70.5(b) and (c) of this chapter.
I agree the analogy was bad in this case .... but along the same lines
I don't think you can assume the dye will be released in the GI tract. It could be passed through without being released.
Amigo Mike
That's a pretty terrible analogy.
The blue dye doesn't affect anything or cure anything, it is easy to see it's not the active ingredient.
What if you just give it a sugar coating so it taste sweet, is that going to be a big problem with the advisory committee too? Ok, so no one had done that with opioid drugs before, we should probably require additional testing to make sure the sugar coating is safe?
We added some blue dye so that when crushed, you're going to get stained blue. That's not any different than making it taste sweet by adding some sugar or any food additive.
The purpose of the dye is to flag signs of abuse. It function as a marker. The FDA has no reason to be concerned with the dye.
FDA Public Health Advisory: Subject: Reports of Blue Discoloration and Death in Patients Receiving Enteral Feedings Tinted With The Dye, FD&C Blue No. 1
September 29, 2003
Dear Health Care Professional:
The Food and Drug Administration (FDA) would like you to be aware of several reports of toxicity, including death, temporally associated with the use of FD&C Blue No. 1 (Blue 1) in enteral feeding solutions. In these reports, Blue 1 was intended to help in the detection and/or monitoring of pulmonary aspiration in patients being fed by an enteral feeding tube. Reported episodes were manifested by blue discoloration of the skin, urine, feces, or serum and some were associated with serious complications such as refractory hypotension, metabolic acidosis and death. Case reports indicate that seriously ill patients, particularly those with a likely increase in gut permeability (e.g., patients with sepsis), may be at greater risk for these complications. Because these events were reported voluntarily from a population of unknown size, it is not possible to establish the incidence of these episodes.
The only thing to debate about the blue dye is if it's considered and inactive or active ingredient. Its approved for use as a pharmacologically inactive substance by the fda.
Now we know it doesn't furnish pharmacological activity, cure, mitigate anything, treat, diagnose, or affect the structure or function of the body. The ONLY way you can say it can be considered active is if its used to prevent. Which its not really because if its consumed as it's intended then it acts as an inactive ingredient and really does sweet f' all. That's my take
When any color dye is used to make a tablet look more appealing, that is an inactive ingredient, a general use color additive. For "stigmatizing dye," which deeply discolors human tissue, there is an intended effect on the user, and it causes a change to the user. So it meets the definition of active ingredient no matter how you slice it. But even if you want to call it an inactive ingredient for some strange reason, you still have to recognize that it is a bioactive molecule. It has biological activity that can be studied in vitro and described. In the correct human body compartment (blood) at the necessary dose (unknown) in a particular situation (sepsis), it has a very well-described biological effect (death).
Artificial food dyes can inhibit mitochondrial oxidative phosphorylation in vitro by acting as uncouplers (as does 2,4-dinitrophenol), by blocking electron transport (as does cyanide), or by inhibiting energy transformation by blocking the generation of ATP. Blue dye no. 1, a triphenylmethane dye, is a potent inhibitor of mitochondrial respiration in vitro and reduces oxygen consumption by a factor of eight in mitochondrial preparations in vitro. It appears to inhibit energy transformation by blocking the adenine nucleotide translocator (as is the case with atractyloside).
Give even 1 other example.
IPCI's Rexista uses FDA approved batches of blue dye #1 well within the FDA's approved levels...just like the thousands of other drug and food products out there that use FDA approved batches of dye in the FDA approved levels
FD&C blue dye no. 1 was approved by the FDA for use in food after experiments showed that the dye was nontoxic and was not absorbable. However, these experiments were performed in healthy animals. Artificial food dyes can inhibit mitochondrial oxidative phosphorylation in vitro by acting as uncouplers (as does 2,4-dinitrophenol), by blocking electron transport (as does cyanide), or by inhibiting energy transformation by blocking the generation of ATP. Blue dye no. 1, a triphenylmethane dye, is a potent inhibitor of mitochondrial respiration in vitro and reduces oxygen consumption by a factor of eight in mitochondrial preparations in vitro. It appears to inhibit energy transformation by blocking the adenine nucleotide translocator (as is the case with atractyloside).
Although both patients had serious underlying illnesses, their condition was improving before they received the dye and turned color. We hypothesize that the refractory hypotension and metabolic acidosis seen in these patients may be explained by the known biochemical effects of this dye, since neither patient had hypotension or severe acidosis immediately before the discoloration. The hyperthermia in the child may represent an uncoupling effect of FD&C blue dye no. 1 that is not apparent in vitro. We encourage judicious use of this food dye in patients with sepsis or other illnesses associated with increased gastrointestinal permeability.
Clearly if one like Weasel is a shareholder (assuming he is one) he feels the blue dye is going to be a death nail.
death knell
/'deTH ?nel/
noun
the tolling of a bell to mark someone's death.
used to refer to the imminent destruction or failure of something.
"the chaos may sound the death knell for the peace plan"
A·chil·les heel
noun
a weakness or vulnerable point.
synonyms: weak spot, weak point, weak link, weakness, soft underbelly, shortcoming, failing, imperfection, flaw, defect, chink in one's armor; nemesis
"hardware support has traditionally been something of an Achilles heel for the operating system"
Take a break... You are making a fool out of yourself... BAHAHAHAHA!
Scary thought...
The blue dye will pass the Niacin test as it does have a clear use and advantage and that is for early detection of abuse. therefore any known side effects and can be accounted for.
Try reading the whole question...
What's the benefit of skipping the safety study and then holding the application for a year and a half?
Weasel...really? you need someone to answer that? if you can get a product accepted without the need for the study and yes that issue would have been discussed in the pre submission meetings and the IND, why would a company spend 20 to 24 million it doesn't need too?
I never did get an answer to that question.
For crap sake, they could have done the Phase 3 Safety Study TWICE by now. What's the benefit of skipping the safety study and then holding the application for a year and a half?
Just like the niacin in Acurox.
But Weezuhl... The blue dye has been a known part of Rexista for a long period of time. This will not be news to the FDA as I am sure it was part of the original discussions the company had with them at the IND stage.
In 19-1 vote, FDA panel rejects Acurox
"What I'm hearing from the committee is that it's probably not appropriate to put the niacin in this product because it does not have a definitive advantage, and it has associated side effects," said Jeffrey Kirsch, chairman of the Anesthetic and Life Support Drugs Advisory Committee, which voted on the drug.
Here is what I said...
Weezuhl- Wasn't it you who said that since ELTP had to do a PH3 IPCI would eventually have to do a PH3 on Rexista? Looks like no PH3 is likely required so now you move on to the next thing to bash...
It is not for me to prove that Rexista is unsafe. It is for the company to prove that it is safe. That has not been done, either for the new use of blue dye or a Phase 3 Safety Study, which is how these problems are caught. There is no blue dye in OxyContin, which is why I was very surprised there is no Phase 3 Safety Study. There have been no systemic absorption studies in at-risk subgroups. There have been no accumulation studies in patients on chronic opioids. There are no reported HAL studies to show the blue dye does anything, and certainly it does not impart a benefit on the legitimate user.