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Hey longs, if you remember we had som CT in 2011 I thinks with release date of 2016 or so, im wondering if today CT is related. Anyway I agree something is brewing nicely :)
Hey Couch, Lasers and all longs...I see Elite as a company with novel technology which will transform what true ADF mean. Will set new standard. There are only 1million volume for a company of 800mil outstandig shares. This will sky rockets if it see 40 or 50 mil volume a day similar to last few runs.
Good luck all LONGS....
Exactly. He did mention that clrearly. Anybody in doubt can listen to the CC audio recording. ELI 200 is coming and nobody can stop us!
Congrats long! This the best news for Elite in last few years and more to come! This year and next years are ours :)
Hey Laser, a technical question (sorry if this has been discussed before): Elite was very secretive about ELI200 and not disclosing what the drug is and what the doses are, but suddenly after Phase 3 result everything disclosed. What that mean to Elite, the competitors and those big pharma that they were thinking of Elite acquisition ?
TIA
Meshcan
Thanks Mocha Jet. I sent this list to Dianne Will @ Elite
You can check with Investor Relatins ( Dianne) at dianne@elitepharma.com, she can tell if any info are publically available or not at this stage. Always there is a risk but no risk means no reward!
Yes. Good time ahead with ELI200 ADT!
GLTA
Merry Christmas to all longs!
Hey longs, Lasers, Couch, NASDAQ2020, Aqua, senderos, Drugdoctor, Dr PeteRose MLB, no2koolaid, Mazeppa and anybody that I might forget (sorry!), wish you a very happy new year, healthy and with big news of ELI200 approval.
Some of us have been here for almost 5 years and I believe 2016/2017 will be the retirement for some :)
Good luck to you all and Merry Christmas!
Meshcan
Thanks Lasers, Couch and all other longs who respond to the question.
GLTA
Hi Lasers/Couch/NASDAQ2020,
Long time no talk :) , something confused me and I need your help to shade some light here. We know that ELI-200 is an abuse deterrent product for an undisclosed opioid, we were guessing that ELI-200 is Morphine/Nal opiod. In recent PR, it says that" A Phase III efficacy study is scheduled to begin dosing this quarter. This Phase III study is a multi-center, randomized, multiple-dose, blinded, placebo-controlled, parallel group, study to evaluate the efficacy and safety of abuse deterrent ELI-200 for the treatment of adults with moderate to severe pain following surgery. "
But when we look at Clinical Trials in below link it is clearly says Oxycodone/Naltrexone dosing trial which Estimated Study Completion Date is August 2015.
https://clinicaltrials.gov/ct2/show/NCT02401750?term=Elite+Laboratories&rank=2
From the other side we know that ELI-201 is generic Oxycontin, it is public info.
I guess , now you know what I'm going to ask. Based on this, both ELI-200 and Eli-201 are Oxycodone/Naltrexone! Isn't it interesting? Is one ER and one IR or even maybe once-a-day?
Regards,
Zogenix and Purdue Pharma Exchange Waivers of Regulatory Exclusivity for Extended-Release Hydrocodone Products -
See more at: http://globenewswire.com/news-release/2014/10/31/678670/10105325/en/Zogenix-and-Purdue-Pharma-Exchange-Waivers-of-Regulatory-Exclusivity-for-Extended-Release-Hydrocodone-Products.html
Anyone noticed this?
YouTube Audio file Elite Conference Call 18-August-2014 click below link
CLICK HERE: YouTube Audio File Conference Call 18-August-2014
"Nobody can stop us!" ,Nasrat Hakim
"This is our year" , Nasrat Hakim
ELI ADT family! :
ELI-200: Undisclosed Abuse Deterrent opioid (most likely is Morphine/Naltrexone better EMBEDA). BE study done and good result. Even though this was second BE study but will be first NDA to be filed with FDA in 2014. I believe EMBEDA has once-daily and twice-daily, that's why Hakim pushing this first, we will have two version ELI-200 Mor/Nal once-daily and twice-daily. My opinion!
January 14, 2014: First dosing of a pivotal bioequivalence study in healthy volunteers
March 05, 2014: Pivotal bioequivalence study successful result.
June 09, 2014: Human abuse liability clinical study for ELI-200 started
ELI-201: Oxycodone/Naltrexone twice-daily with ART/ADT. BE Study done and good result. Will be filed NDA with FDA in 2014. Three different twice daily formulations developed by Elite were tested in the study. This is generic of OxyContin.
December 05, 2013: First dosing of a Pilot bioequivalence study in healthy volunteers
February 18, 2014:Successful results from a pilot bioequivalence study
July 15, 2014: First dosing of a Pivotal bioequivalence study in healthy volunteers
ELI-202: Hydrocodone/Naltrexone twice-daily with ART/ADT.
May 19, 2014: First dosing of a pivotal bioequivalence study in healthy volunteers. Two bioequivalence studies will be run together.
ELI-216: Oxycodone/Naltrexone once-daily with ART/ADT.
ELI-154: Oxycodone once-daily ER with no ART/ADT , scale up at Elite for a $ 400 million dollar market in Europe.
GLTA
YouTube Audio file Elite Conference Call 18-August-2014 click below link
CLICK HERE: YouTube Audio File Conference Call 18-August-2014
"Nobody can stop us!" ,Nasrat Hakim
"This is our year" , Nasrat Hakim
ELI ADT family! :
ELI-200: Undisclosed Abuse Deterrent opioid (most likely is Morphine/Naltrexone better EMBEDA). BE study done and good result. Even though this was second BE study but will be first NDA to be filed with FDA in 2014. I believe EMBEDA has once-daily and twice-daily, that's why Hakim pushing this first, we will have two version ELI-200 Mor/Nal once-daily and twice-daily. My opinion!
January 14, 2014: First dosing of a pivotal bioequivalence study in healthy volunteers
March 05, 2014: Pivotal bioequivalence study successful result.
June 09, 2014: Human abuse liability clinical study for ELI-200 started
ELI-201: Oxycodone/Naltrexone twice-daily with ART/ADT. BE Study done and good result. Will be filed NDA with FDA in 2014. Three different twice daily formulations developed by Elite were tested in the study. This is generic of OxyContin.
December 05, 2013: First dosing of a Pilot bioequivalence study in healthy volunteers
February 18, 2014:Successful results from a pilot bioequivalence study
July 15, 2014: First dosing of a Pivotal bioequivalence study in healthy volunteers
ELI-202: Hydrocodone/Naltrexone twice-daily with ART/ADT.
May 19, 2014: First dosing of a pivotal bioequivalence study in healthy volunteers. Two bioequivalence studies will be run together.
ELI-216: Oxycodone/Naltrexone once-daily with ART/ADT.
ELI-154: Oxycodone once-daily ER with no ART/ADT , scale up at Elite for a $ 400 million dollar market in Europe.
GLTA
YouTube Audio file Elite Conference Call 18-August-2014 click below link
CLICK HERE: YouTube Audio File Conference Call 18-August-2014
"Nobody can stop us!" ,Nasrat Hakim
"This is our year" , Nasrat Hakim
ELI ADT family! :
ELI-200: Undisclosed Abuse Deterrent opioid (most likely is Morphine/Naltrexone better EMBEDA). BE study done and good result. Even though this was second BE study but will be first NDA to be filed with FDA in 2014. I believe EMBEDA has once-daily and twice-daily, that's why Hakim pushing this first, we will have two version ELI-200 Mor/Nal once-daily and twice-daily. My opinion!
January 14, 2014: First dosing of a pivotal bioequivalence study in healthy volunteers
March 05, 2014: Pivotal bioequivalence study successful result.
June 09, 2014: Human abuse liability clinical study for ELI-200 started
ELI-201: Oxycodone/Naltrexone twice-daily with ART/ADT. BE Study done and good result. Will be filed NDA with FDA in 2014. Three different twice daily formulations developed by Elite were tested in the study. This is generic of OxyContin.
December 05, 2013: First dosing of a Pilot bioequivalence study in healthy volunteers
February 18, 2014:Successful results from a pilot bioequivalence study
July 15, 2014: First dosing of a Pivotal bioequivalence study in healthy volunteers
ELI-202: Hydrocodone/Naltrexone twice-daily with ART/ADT.
May 19, 2014: First dosing of a pivotal bioequivalence study in healthy volunteers. Two bioequivalence studies will be run together.
ELI-216: Oxycodone/Naltrexone once-daily with ART/ADT.
ELI-154: Oxycodone once-daily ER with no ART/ADT , scale up at Elite for a $ 400 million dollar market in Europe.
GLTA
rfwelsh , when lab studies were started? did we get PR on that? any details?
YouTube Audio file Elite Conference Call 1-July-2014 click below link (reposting CC Audio file)
CLICK HERE: YouTube Audio File Conference Call 1-July-2014
"Nobody can stop us!" ,Nasrat Hakim
"This is our year" , Nasrat Hakim
ELI ADT family! :
ELI-200: Undisclosed Abuse Deterrent opioid (most likely is Morphine/Naltrexone better EMBEDA). BE study done and good result. Even though this was second BE study but will be first NDA to be filed with FDA in 2014. I believe EMBEDA has once-daily and twice-daily, that's why Hakim pushing this first, we will have two version ELI-200 Mor/Nal once-daily and twice-daily. My opinion!
January 14, 2014: First dosing of a pivotal bioequivalence study in healthy volunteers
March 05, 2014: Pivotal bioequivalence study successful result.
June 09, 2014: Human abuse liability clinical study for ELI-200 started
ELI-201: Oxycodone/Naltrexone twice-daily with ART/ADT. BE Study done and good result. Will be filed NDA with FDA in 2014. Three different twice daily formulations developed by Elite were tested in the study. This is generic of OxyContin.
December 05, 2013: First dosing of a Pilot bioequivalence study in healthy volunteers
February 18, 2014:Successful results from a pilot bioequivalence study
July 15, 2014: First dosing of a Pivotal bioequivalence study in healthy volunteers
ELI-202: Hydrocodone/Naltrexone twice-daily with ART/ADT.
May 19, 2014: First dosing of a pivotal bioequivalence study in healthy volunteers. Two bioequivalence studies will be run together.
ELI-216: Oxycodone/Naltrexone once-daily with ART/ADT.
ELI-154: Oxycodone once-daily ER with no ART/ADT , scale up at Elite for a $ 400 million dollar market in Europe.
GLTA
YouTube Audio file Elite Conference Call 1-July-2014 click below link
YouTube Audio File Conference Call 1-July-2014
"Nobody can stop us!"
"This is our year"
ELI ADT family! :
ELI-200: Undisclosed Abuse Deterrent opioid (most likely is Morphine/Naltrexone better EMBEDA). BE study done and good result. Even though this was second BE study but will be first NDA to be filed with FDA in 2014. I believe EMBEDA has once-daily and twice-daily, that's why Hakim pushing this first, we will have two version ELI-200 Mor/Nal once-daily and twice-daily. My opinion!
ELI-201: Oxycodone/Naltrexone twice-daily with ART/ADT. BE Study done and good result. Will be filed NDA with FDA in 2014. Three different twice daily formulations developed by Elite were tested in the study. This is generic of OxyContin.
ELI-202: Hydrocodone/Naltrexone twice-daily with ART/ADT.
ELI-216: Oxycodone/Naltrexone once-daily with ART/ADT.
ELI-154: Oxycodone once-daily ER with no ART/ADT , scale up at Elite for a $ 400 million dollar market in Europe.
GLTA
YouTube Audio file Elite Conference Call 1-July-2014
YouTube Audio File Conference Call 1-July-2014
"This is our year"
ELI ADT family! :
ELI-200: Undisclosed Abuse Deterrent opioid (most likely is Morphine/Naltrexone better EMBEDA). BE study done and good result. Even though this was second BE study but will be first NDA to be filed with FDA in 2014. I believe EMBEDA has once-daily and twice-daily, that's why Hakim pushing this first, we will have two version ELI-200 Mor/Nal once-daily and twice-daily. My opinion!
ELI-201: Oxycodone/Naltrexone twice-daily with ART/ADT. BE Study done and good result. Will be filed NDA with FDA in 2014. Three different twice daily formulations developed by Elite were tested in the study. This is generic of OxyContin.
ELI-202: Hydrocodone/Naltrexone twice-daily with ART/ADT.
ELI-216: Oxycodone/Naltrexone once-daily with ART/ADT.
ELI-154: Oxycodone once-daily ER with no ART/ADT , scale up at Elite for a $ 400 million dollar market in Europe.
GLTA
ELI-200 is better EMBEDA...CEO kind of confirmed it. Listen to CC.
Elite has two ANDA pending FDA approval...UPDATE
From: Dianne Will <dianne@elitepharma.com>
Date: Mon, Apr 28, 2014 at 2:49 PM
Subject: RE: ANDA pending FDA approval
To: meshcan <meshcan@gmail.com>
From: meshcan [mailto:meshcan@gmail.com]
Sent: Monday, April 28, 2014 9:03 AM
To: Dianne Will
Subject: Re: ANDA pending FDA approval
Good Morning Dianne,
A few more questions that I hope you can help:
1). I'm interested to know when exactly these two ANDA have been filed with FDA. Is there anyway you can find this out from Elite?
I don’t know the exact dates. I know it has been more than two years since they were filed.
2). I see in the Elite website both ELI-201 and ELI-200 have been identified as NDA. As both are generic and have branded product, shouldn't it be ANDA?
No. They will be filed as a new drug application and will receive either a priority or standard review which is six months or ten months respectively.
It seems that ANDA’s filed with the FDA are averaging three years for review.
Best regard,
Dianne.
"Elite has two ANDA pending FDA approval "
Exactly NASADAQ2020 and if they release the monster news then nobody can stop it and price will go to $4 in a blink...
I asked a few more questions from Dianne, I'll update later.
Elite has two ANDA pending FDA approval
One is over two years with FDA and it seems close to approval. I'm wondering what it is!
Please see below what Dianne replied.
http://www.elitepharma.com/product_pipeline.asp
From: Dianne Will <dianne@elitepharma.com>
Date: Tue, Apr 22, 2014 at 1:27 PM
Subject: RE: ANDA pending FDA approval
To: Meshcan <meshcan@gmail.com>
Dear Meshcan
It is my understanding that ANDA reviews with the FDA are currently running about three years for review/approval.
I do not have the dates of when these were filed, but I believe one has been at the FDA for more than two years at this point. I have no idea of when we can expect approvals as the FDA does not provide PDUFA dates for generic drug filings like they do for branded products. We simply have to wait until we hear from the FDA on this.
Best regards,
Dianne.
From: Meshcan [mailto:meshcan@gmail.com]
Sent: Tuesday, April 22, 2014 10:05 AM
To: dianne@elitepharma.com
Subject: ANDA pending FDA approval
Hi Dianne,
We have two undisclosed drug that are pending FDA approval per Elitepharma website. Can you please advise when we've filed ANDA with FDA. Are we still communicating/responding to FDA question/concerns about this two drugs? Any estimated time of approval? Any other info that you can share about these?
Have a good day,
Thanks,
Meshcan
I agree $4/share is just for first ADT and we will go way higher than that for all 15 ADT opiods..
I'm wondering who can apply plug n play ADT technology to Moxduo. Note lack of question mark :)
BTW, Actavis also is in investor in Moxduo drug!
Agreed, we are trading 5 folds comparing last year!
Those 40 mil is good for accelerate developing and human study for ADT/ART drugs that Elite is developing. The most important thing that many people forget is production. If we want to Launch ELI-200 and ELI-201 next year, we need huge money to buy material, hire people, ramp up production and distribute. That cycle definitely need money way more than 40 mil. Yes, if we want to capture a good market share and have a few hundred million revenue, we need to spend a lot of money to reach there.
GLTA
Nasrat Hakim knows how to play! he is a good player and professional CEO on Pharma market. Now is ELTP terms on any negotiation for partnership.
He wants to protect shareholders assets.
By the way, who is the biggest shareholder. Note lack of question mark (LOL this is Couch signature!, sorry Couch)
Like Nasrat.
GLTA
ELTP retirement fund.
I set a buy request for more shares tomorrow. It is for slightly less than 100k shares and I want to use it toward buying a nice car for my family for the Christmas or sooner! My multi hundered thousands core shares that I bought in March 2011 will stay untouched for early retirement!
GLTA
Great, whoever is interested can read page 5 of the document Couch shared,
"
A formulation that, upon manipulation, would result in the release of pharmacologic antagonists to the opioid, thereby creating a substance that would either decrease the product’s pharmacologic effects (e.g., euphoria) or result in a mild to moderate degree of drug withdrawal when the manipulated substance is injected or administered by another route of abuse.
"
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf
Great! thanks Destiny
Wow, Good job, you got your answer then. Your mission completed, LOL
Good job, you got your answer then. LOL
You can ask Dianne in Investor Relation, do you have her number? LOL
Also you can call in next CC.
You have many choices.
As I said Nasrat will be the ONLY one to decide when is TIME...
Transparency is good but timing is defined by CEO.
You can ask Dianne in IR too!!!
Actually they are working closely with FDA. You know why? FDA requires more opiods with superior ADT on the market. Do you know who has superior ADT technology with many patents??
Thanks Lasers. I mixed these ELI-200 and ELI-201 alot!! LOL
"This is our year"
ELI ADT family! :
ELI-200: Undisclosed Abuse Deterrent opioid (most likely is Morphine/Naltrexone better EMBEDA). BE study done and good result. Even though this was second BE study but will be first NDA to be filed with FDA in 2014. I believe EMBEDA has once-daily and twice-daily, that's why Hakim pushing this first, we will have two version ELI-200 Mor/Nal once-daily and twice-daily. My opinion!
ELI-201: Oxycodone/Naltrexone twice-daily with ART/ADT. BE Study done and good result. Will be filed NDA with FDA in 2014. Three different twice daily formulations developed by Elite were tested in the study. This is generic of OxyContin.
ELI-202: Hydrocodone/Naltrexone twice-daily with ART/ADT.
ELI-216: Oxycodone/Naltrexone once-daily with ART/ADT.
ELI-154: Oxycodone once-daily ER with no ART/ADT , scale up at Elite for a $ 400 million dollar market in Europe.
Well said...."he FDA will be the one's who decide if Elite' ADT is good enough or not. So far the FDA has no complaints."
Lasers, sorry for repeating Pete question again, it says "The ELI-201 pilot study showed that more than one of Elite’s formulations was bioequivalent to the brand product" doesn't that mean ELI-201 (Mor/Nal) has different formulations, I guess we have different size of Naltrexone bead so that's why we have different formulations of ELI-201...the other guess is we have once daily and twice daily EMBEDA and therefore we have once-daily ELI-201 and twice-daily ELI-201...
Any thought?
GLTA
Why you are worried about the result Dr_LOW...?
Nasrat will announce them when is TIME...they said the result is great and superior than many others. We trust Nasrat that says the truth.
Nasrat and his team verify, analyze data and release when is in the benefit of Elite and shareholders.
Nasrat will be the ONLY one to decide when is TIME...
GLTA Longs