pagiantmetknicksfan@yahoo.com
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We all know Elite's approach works. Thats just science. Embeda with the same pharmacological approach works but they obviously have manufacturing issues still....Good science...but bad idea on their part...]
And basically your comments prove as we know already that Elite will get FDA approval and pass trial after trial for ADT opioid...one after the other after the other....And that is just science..
Here is how it works...If I sold my shares I am looking to buy back cheaper. If I am still accumulating I am looking to buy cheap...If I have bought all I want I disappear until I have sold...This is how the stock is traded right now....Sell some...buy some....low volume, try to move the price down..accumulate now...etc...Heavy MM influence right now too or supported...I guess it depends on how you look at it.
except they are nothing alike....but besides that they are similar...lol
Here is how it works...If I sold my shares I am looking to buy back cheaper. If I am still accumulating I am looking to buy cheap...If I have bought all I want I disappear until I have sold...This is how the stock is traded right now....Sell some...buy some....low volume, try to move the price down...etc...Heavy MM influence right now too or supported...I guess it depends on how you look at it.
Traders sell into the bid and then need someone else to sell to move price down..all day every day on ELTP
He never said anything about a promise for a partnership..more made up stuff...lol
Nah...just regular stock manipulation on OTC as stock is being accumulated...we all know it by now..
Or what? Lol...hahahaha...I am buying too...lol
Its not regular retail....lol....but it works for me cause I have shares to buy...Traders sell some shares trying to move the price down....same pattern day after day
When I see MMs stacked up on the ask or the same MM on the ask trying to hold the price down..I call that manipulation...especially when you know it is not regular retail...Same old manipulation...has been this way for a while...enjoying it really...
I could go on and on about what is going on right now...but I still have shares to buy...lol
Here is how it works...If I sold my shares I am looking to buy back cheaper. If I am still accumulating I am looking to buy cheap...If I have bought all I want I disappear until I have sold...This is how the stock is traded right now....Sell some...buy some....low volume, try to move the price down...etc...Heavy MM influence right now too or supported...I guess it depends on how you look at it.
Here is how it works...If I sold my shares I am looking to buy back cheaper. If I am still accumulating I am looking to buy cheap...If I have bought all I want I disappear until I have sold...This is how the stock is traded right now....Sell some...buy some....low volume, try to move the price down...etc...Heavy MM influence right now too or supported...I guess it depends on how you look at it.
Yah....follow the lowest common denominator....chart swallowers sold at .18 last time too....but in the meantime......stock is going to explode again before too long...
I don't believe in January effect really. I believe in manipulation down in December trying to scare people into believing tax loss selling is going on constantly. Great for those accumulating shares though....
Nothing wrong with taking profits. Merry xmas to you too. It is all about how we conduct ourselves in the end. Cap is stupid low right now. Any pharma with positive trial results like this and a pretty much guaranteed line of future approvals and trial results should carry a many x higher valuation....not even including the generic drug business line which is pretty nice too.
What was the news that drove to to .97 before? The stock is in accumulation mode by many....not retail included....I will give you a hint...it wasnt news and it was P&D....it was distribution after accumulation. Traders sold at .18...lol
The stock has been a handful of traders trying to work the price down for a few weeks. Watch BMAK on the ask constantly trying to move it down. Trying to get someone to put in an ask ahead of him. And then he will bid sit and work it down.
They are going to run this one hard again. With a cap sitting around $110m and positive clinical trials and more expected plus NDA filing (probably several once they know what the FDA is fully expecting-officially since they probably already know through Camargo)
You are looking at 4-6x gains maybe more.
Also expect a marketing and sales deal here too since they are doing that DD now.
This is about as great a risk/reward as you will find right now. Little risk and very high reward.
Good stuff. Congrats man.
So still nothing that even suggests Elite will not get an approval? Pretty amazing really. A lot of statements below but not one single one that suggests any reason they will not get approval for an entire line of abuse deterrent opioids.
Elite Pharmaceuticals Reports Results of Pilot Bioequivalence Study for ELI-201
...Provides Update on Pivotal Study for Second Opioid Abuse Deterrent Product and Manufacturing Transfer of Generic Products
Northvale, New Jersey, Tuesday, February 18, 2014:
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB: ELTP) announced today successful results from a pilot bioequivalence study initiated in December 2013 for ELI-201, a twice-daily opioid abuse deterrent oxycodone product with abuse deterrent technology. Three different twice daily formulations developed by Elite were tested in the study. The study results demonstrate that all formulations in the study were bioequivalent to the reference drug based on pharmacokinetic measures including peak plasma concentration (Cmax) and area under the curve (AUC) for oxycodone blood plasma levels. The study was a single dose, open label, randomized, four period, four treatment, cross over study in 16 healthy volunteers under fasted conditions.
The formulations tested utilize Elite's proprietary pharmacological abuse deterrent technology with the opioid antagonist naltrexone. Levels of sequestration of naltrexone were evaluated based upon a naltrexone assay with a level of detection (LOD) of 4 pc/mL. The study results demonstrated that Elite's formulations were superior to an approved and marketed comparator product using a similar pharmacological approach. The comparison was based upon publicly available data from a similar fasted study in healthy volunteers and using a similar naltrexone assay with an LOD of 4 pc/mL. The primary metabolite of naltrexone, 6-Beta-natrexol, was also analyzed in the Elite study although no data from the comparator product was available for direct comparison.
As previously announced, Elite initiated a pivotal bioequivalence study for an undisclosed opioid abuse deterrent product in January and dosing for this study has now been completed. Results from the study are expected in March.
In addition, supplements are being prepared to file with the FDA for manufacturing site transfers for the first four of twelve approved generic products. Elite expects to file a Changes Being Effected in 30 days (CBE-30) in March for Isradipine, 2.5 mg and 5.0 mg capsules for transfer of manufacturing of this product to Elite's facility. Elite also expects that its partner, Epic Pharma, will file with the FDA a CBE-30 for Dantrolene Sodium, 25 mg, 50 mg and 100 mg capsules, Loxapine 5mg, 10mg, 25 mg, 50 mg capsules and Hydroxyzine 10 mg, 25 mg, 50 mg tablets for transfer of manufacturing of this product to Epic's facility in June. Although we hope to launch the products 30 days after these filings, Elite cannot guarantee when these products will launch as it is dependent on FDA acceptance of the filing.
"We are delighted with the results from our clinical studies and pleased to have confirmation of the formulation for our extended release product, ELI-201, our twice-daily oxycodone product and the progress of the second opioid," stated Nasrat Hakim, President and CEO for Elite. "We are also on track with the manufacturing site transfer of the twelve generic products Elite is adding to the product line. The transfers of these products have been prioritized and we will have additional supplements to file following these first two products."
About Elite's Abuse Deterrent Technology
Elite's abuse deterrent products utilize the Company's proprietary pharmacological abuse deterrent technology. Elite's abuse deterrent technology is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist. Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry. Elite has seven commercial products currently being sold, twelve additional approved products pending manufacturing site transfer and two additional products under review pending approval by the FDA. Elite's lead pipeline products include abuse resistant opioids utilizing the Company's patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the manufacturing and distribution of eleven approved products pending manufacturing site, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations
518-398-6222
Dianne@elitepharma.com
Elite Pharmaceuticals Reports Successful Pivotal Bioequivalence Study for Abuse Deterrent Product ELI-200
Northvale, New Jersey, Wednesday, March 05, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) announced today successful results from a pivotal bioequivalence study initiated in January 2014 for Elite’s undisclosed abuse deterrent opioid product, ELI-200. The study results demonstrated Elite’s product is bioequivalent to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) for opioid blood plasma levels. The study was a single dose, open label, partially randomized, three-way cross over study in healthy volunteers with 42 subjects under fasted conditions and 38 subjects under fed conditions.
The formulation utilized Elite’s proprietary pharmacological abuse deterrent technology with the opioid antagonist naltrexone. Levels of sequestration of naltrexone were also evaluated and dosing of Elite’s intact formulation resulted in almost no exposure levels to naltrexone (LOQ of 4 pg/mL) and its metabolite 6-?-naltrexol (LOQ of 10 pg/mL) as intended. Elite will proceed with the development program for this product including completion of a human abuse liability study. Elite expects to file an NDA for this product by year end.
“As I have stated before, we have set in motion several initiatives that will have significant impact on Elite’s future,” commented Nasrat Hakim, Elite’s President and CEO. “Following the success of the pilot bioequivalence study in December for ELI-201, we are delighted with the results of this pivotal bioequivalence clinical study for ELI-200, our second opioid abuse deterrent product. ELI-200 is expected to be filed this year and will be the first NDA product filed by Elite with the U.S. Food and Drug Administration.”
The bioequivalence studies for these opioid abuse deterrent products are being conducted under the direction of Camargo Pharmaceutical Services.
About Elite’s Abuse Deterrent Technology
Elite’s abuse deterrent products utilize the Company’s proprietary pharmacological abuse deterrent technology. Elite’s abuse deterrent technology is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist. Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers.
About Section 505(b)(2)
The Company plans to file an NDA for this product based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act. Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug.
About Camargo Pharmaceutical Services
Camargo is a full-service drug development partner specializing in the 505(b)(2) process — an approach for developing products that offer differentiated benefits. Camargo is capable of managing every facet of the plan throughout the development continuum, from feasibility assessments, formulation and testing the drug product, to conducting preclinical and clinical studies, to final submission.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry. Elite has seven commercial products currently being sold, twelve additional approved products pending manufacturing site transfer and two additional products under review pending approval by the FDA. Elite’s lead pipeline products include abuse resistant opioids utilizing the Company’s patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the manufacturing and distribution of eleven approved products pending manufacturing site, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
ELITE PHARMACEUTICALS RELEASES POSITIVE TOP LINE HUMAN ABUSE LIABILITY DATA FOR ELI-200, AN OPIOID ABUSE DETERRENT PRODUCT
HAL study compared subjective effects of drug liking, drug high and good drug effects between ELI-200 and the comparator formulation in non-dependent recreational drug users
Northvale, New Jersey, Tuesday, September 09, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) today reported top line results from a Human Abuse Liability (HAL) study for the ELI-200 product. ELI-200 is an undisclosed abuse deterrent opioid product for pain.
The study results demonstrated statistically significant (p <.0001) lower measures of drug liking, drug high and good drug effects for Elite’s manipulated (crushed) ELI-200 when compared to the manipulated (crushed) drug listed comparator product and found 91.9% of the subjects experienced increased drug liking with the comparator product compared to ELI-200 in non-dependent recreational drug users when administered intranasally. The study also found 80.6% of the subjects experienced a decrease in drug liking with the intranasal crushed ELI-200 in comparison to the administration of oral intact ELI-200.
The data will be presented at the 16th Annual Rodman and Renshaw Global Investment Conference in New York City on September 9, 2014.
“We could not be more pleased with the top line result from the Human Abuse Liability Study for ELI-200 which confirms the effectiveness of our abuse deterrent technology,” said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “This successful technology will be the platform for an entire line of opioid products utilizing our proprietary technology. We remain on track to file our first new drug application for ELI-200 by December 2014.”
HAL Study Details
The HAL study was a single-center, randomized, double-blind, double-dummy, active- and placebo-controlled, single-dose, five-way crossover to evaluate the relative bioavailability, abuse potential and safety of crushed intranasal ELI-200 capsules compared to the crushed intranasal comparator product, oral intact ELI-200, and placebo in 37 healthy male and female non-dependent recreational opioid users with intranasal experience. The primary objective was to assess the abuse potential of ground ELI-200 relative to the crushed comparator product when administered intranasally to non-dependent, recreational opioid users with intranasal experience.
The secondary objectives were:
• To assess the abuse potential of crushed intranasal ELI-200 relative to placebo (intranasal and oral) in non-dependent, recreational opioid users with intranasal experience.
• To assess the abuse potential of oral intact ELI-200 relative to crushed intranasal ELI-200, crushed intranasal comparator, and placebo (oral and intranasal) in non-dependent, recreational opioid users with intranasal experience.
• To assess the relative bioavailability of the opioid in plasma from crushed intranasal and oral intact ELI 200 compared with one another and crushed comparator when administered intranasally in non-dependent, recreational opioid users with intranasal experience.
• To assess the safety of crushed intranasal and oral intact ELI-200 compared with crushed intranasal comparator and placebo (intranasal and oral) in non-dependent, recreational opioid users with intranasal experience.
The full report from the HAL studies is expected in October.
HAL studies are included in the FDA’s Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling (January 2013). These studies are an important tool for the FDA to assess the relative abuse potential of a new drug. For drugs with abuse-deterrent properties, a HAL study assesses the impact of the potentially abuse-deterrent formulation on measures that predict how probable it is that the medication will be attractive to abusers. The industry guidance recommends that a Visual Analog Scale (VAS) be used to measure drug liking, drug high, good drug effects and other qualities.
Update on Other Development Programs
In addition, the Company also reports results from pivotal and pilot bioequivalence studies for ELI-202. The study results from the pivotal study for ELI-202 demonstrated Elite’s product, both the lowest strength and the highest strength, were bioequivalent for the opioid to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) for opioid blood plasma levels. ELI-202 is combination drug that contains a second drug and the study results for the second drug showed bioequivalence for AUC, but a lower Cmax. No food effect was seen with either drug. The study was a single dose, open label, partially randomized, three-way cross over study in healthy volunteers with 32 subjects under fasted conditions and under fed conditions.
Prior to receiving the complete and final report for this study, Elite initiated a pilot study to understand and address the lower Cmax for the combination drug. Two formulations were dosed in the pilot study and both formulations demonstrated that a repeat bioequivalence study with 32 subjects or more would be expected to be bioequivalent for the measured parameters. The pilot study was a single dose, open label, randomized, three period, crossover study in 8 healthy volunteers per arm under fasted conditions. A repeat bioequivalence study for ELI-202 is scheduled to begin in early October.
The formulations utilized Elite’s proprietary pharmacological abuse deterrent technology with the opioid antagonist naltrexone. Levels of sequestration of naltrexone were also evaluated and dosing of Elite’s intact formulation resulted in almost no exposure levels to naltrexone (LOQ of 4 pg/mL) and its metabolite 6-?-naltrexol (LOQ of 10 pg/mL) as intended.
“Our technology continues to perform as expected with positive outcomes,” continued Mr. Hakim. “There will be no impact on our target filing for ELI-202 in Q4 2015.”
About Elite’s Abuse Deterrent Technology
Elite’s proprietary abuse deterrent technology is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid antagonist. Naltrexone is an opioid receptor antagonist used primarily in the management of alcohol dependence and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive for abuse or misuse by recreational drug abusers. Elite’s pharmacological approach to abuse resistance can be applied to a wide range of opioids used today in pain management.
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company developing a pipeline of proprietary pharmacological abuse-deterrent opioid products and niche generic products. Elite specializes in oral sustained and controlled release drug products with high barriers to entry. Elite has seven commercial products currently being sold, twelve additional approved products pending manufacturing site transfer and two additional products under review pending approval by the FDA. Elite’s lead pipeline products include abuse-deterrent opioids utilizing the Company’s patented proprietary technology, and a once-daily opioid. They are sustained release oral formulations of opioids for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Elite also provides contract manufacturing for Ascend Laboratories (a subsidiary of Alkem Laboratories Ltd.) and has partnered with Epic Pharma for the manufacturing and distribution of eleven approved products pending manufacturing site transfer, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop a branded product for the United States market and its territories. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
Contact:
Elite Pharmaceuticals, Inc.
Dianne Will, Investor Relations, 518-398-6222
Dianne@elitepharma.com
It actually has been spectacular. The company is rolling and the balance sheets look great. The trials have all gone as expected and the market they WILL be entering is billions.
Again no one has anything to note why this company will not succeed. Isn't that the goal of a company? To succeed...
The truth is that no one really knows what the FDA is going to do here. Elite has submitted everything they needed to. The FDA has not seen a product like this before as noted.
The beads are separate and the product is Bio-equivalent. So what does running an efficacy trial get you? It doesn't really add any value so why will the FDA require one?
No one knows how the FDA is going to go here and whether they do or not doesn't really impact Elite either way except for a few months time difference.
So the answer is that we are all waiting on the FDA now.
Again, you have nothing to support that it is not on track. Actually they are ready to file now...Not sure how you missed that but there is a replay of the call you can check out soon.
They don't need any new financing....lol...They have 7m in cash. Not sure what you are talking about but listen to the call again ...might help you there with that.
Basically there are two scenarios. FDA says they want an efficacy trial. Elite will pass as Opioids relieve pain and have known to do so for 100 years and the product is already proven to be bio-equivelant...It is a generic drug and the Naltrexone is shown not to leak, passed the HAL studies, and is solid on stability.
The FDA does not require and we file immediately.
Either way under expedited review.
There really is nothing to complain about. Anything negative here has been pure speculation for speculations sake without any data. Nasrat has been 100% forthright but these markets are heavily manipulated by traders and games.
The price gets forced down and people that should not be investing say OMG OMG something bad has happened. Did anyone actually look at the companies cash and financial position? And considering what lies ahead for them, it is pretty remarkable.
People that hold shares will make a ton of money. People that trade will make some money. How one goes about their personal business is something they have to live with. I do wonder if it was like this 10 years ago, 20 years ago?
And still no one can tell me why there is anything to fear whatsoever from the products, trial results or otherwise. Basically as I keep saying either the stock will be worth a ton in a month or so or in a few months.....As I keep noting over and over...
Yet somehow I have not been confused about what Nasrat has said in any way and noting the same things he has been noting....for a long time....hmmmm
I would and they are on track to file now....LOL LOL
So long term investors wait to hear whether they will make a crap ton of money next month or in a few months....
And traders try to find an angle to make a few bucks in between.
Right now long term investors have been winning
Got a link for any of that? I know you don't.
?Flooded the market? With 6m shares? That is flooded? That is about 2% of the OS I think. I have a different definition of the word flooded. The financial situation of this company right now is pretty incredible.
They actually have 6 products in various stages. You could have called in and asked about it. Eli 200 is the key product really. They are all generics. Eli 200 is the first domino. The value here is ridiculous.
They are on track. They have fulfilled everything they are required to and then some. Now it is up to the FDA to decide if it is enough. Basically the same things many here have been saying. like myself and Couch and others.
No delay was announced. Actually what has occurred is exactly what Nasrat said before. They have to hear what the FDA decides. They have fulfilled everything they said they would. Now traders who are working this stock as I note would like to create the perception that a delay was announced but one was not.
In fact saying there is a delay is making something up.
Traders make money based on creating a perception via trading. These items have nothing to do with truth and the PPS does not reflect the call or the company in OTC land like it does on a bigger board stock. There are quite a number of manipulators on this stock which require the creation of fear via trading, manipulating, shorting etc.....The more money you have the more you can do....Even Jim Kramer has noted this.
Anyone that listened to the call knows it was very positive and things are going extremely well. However, the more a price can be manipulated, the more money people can make. The lower volume and lower the price the less cash it takes to manipulate a price.
What this company has done and is poised to do is amazing.
Something occurred to me as I am currently shopping for Health insurance. If Oxycontin has no generic on the market. Then there is clearly a need for generics, desire to lower health care costs etc...
As opioid generics are eliminated or look to be substituted for ADT versions, it makes perfect sense that the FDA would push through these generic versions very quickly..Between the urgency over abuse and urgency over costs and needing ADT and generic choices, these drugs likely get pushed in an expedited manner.
You should post more.....
Filed under "Things no one said ever"
Ohh plenty of evidence of that...day in and day out...LOL LOL
Partnership now...I agree it is likely..
However, exciting to see the soon to play out race to the top. Still haven't been given any reason to believe there is any reason that Elite will not succeed. Not one...LOL
That is what is so funny about the arguments. Even if an efficacy test is required, no one can give any reason why it wouldn't pass. The Oxy beads are separate.....it is a generic drug. They know the plasma profile and those trials proving that have been stellar. Elite can make generic drugs. And we know the Naltrexone beads don't leak as well. So while there is no common sense reason to do an efficacy trial, no one can give legitimate reasons to fear one.