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Not announced yet but most likely financials come out 2/17 and conference call the next day is my guess.
Novartis bought it.
Thanks N2K.
That speaks VOLUMES. This is my new signature!
U.S. Pain Foundation: Access to Abuse-Deterrent Medications Is Critical
Posted On 26 Jan 2015
By Paul Gileno
Published in The Connecticut Mirror on January 26, 2015
Each day it seems, we are reading a new story about another life lost or ruined by addiction to prescription medication. There’s no doubt illegal use of prescription drugs has turned into a major problem — here in Connecticut, across New England and the country.
There is a misconception that those who become addicted to prescription medication are pain patients. As a pain patient myself, and the founder of an organization designed to help people with pain, I can tell you — that perception is wrong.
People waking up every day with chronic pain are not the crux of the prescription drug abuse epidemic. Abuse comes when those medications fall into the wrong hands.
The issue for lawmakers and for society as a whole is how to balance the need for those living with chronic pain to have access to the medications their doctors prescribe, while at the same time making sure those who would choose to abuse these medications can’t do so.
It is a complex problem, and many stakeholders have ideas for taking it on. One aspect of a potential solution is emerging as a common sense step and could make a major impact in stopping the illicit use of pain medication here in Connecticut.
Abuse deterrent formulation, or ADF, is a new technology that is being implemented by the pharmaceutical industry to prevent the abuse of prescription pain medications.
ADF technology is a big step forward in curbing prescription drug abuse. Due to the way ADF medications are developed, the drugs cannot be crushed, injected or otherwise altered to achieve a high.
While ADF medications are not the only tools that should be used to stem the rising tide of prescription drug abuse, the technology should be on the front line in that fight.
That is why my organization, the U.S. Pain Foundation, which proudly calls Connecticut home, is supporting legislation this session that would give patients who need pain management medication greater access to ADF technology.
SB 21 would require insurance companies to cover ADF medications at the same level as traditional pain medications.
If passed, Connecticut would be following in the footsteps of states like Massachusetts, which last year was the first state in the nation to pass similar legislation. Lawmakers there and in other states see ADF technology as a way to help put a stop to the unnecessary abuse of these critical medications, while not penalizing those who have legitimate need for pain relief.
Connecticut has a long history of embracing advancements in the biopharmaceutical industry, as well as ensuring patients here in the state have access to the medications that are critical to their health.
This legislation will give parity to ADF medications, and make sure they’re affordable for those who need them.
That will be a real step forward in not only curbing prescription drug abuse, but making sure people living with chronic pain have access to the medications they need to live healthy and productive lives.
Paul Gileno is the founder and president of the U.S. Pain Foundation, headquartered in Middletown, Connecticut.
- See more at: http://claad.org/gileno-abuse-deterrent-medications-could-improve-lives-and-health-in-connecticut/#sthash.MlaIOWiT.dpuf
This is not an alert and we were not compensated for the following watch list.
So someone spams our board and Elite is behind it?
And yet no "information" is provided
Why does that matter? You have a wild opposing theory?
The other shares were payment for the Mikah ANDA's.
They were not free.
Who cares?
What was sweet about the deal? We all know who the CEO was. Why do you feel that is relevant?
He did for the 11 million
How he acquired the ANDAs I have no idea ...
Off to dinner
We can pick this up tomorrow
It's right in the form 4 you posted
He did pay for them in ANDAs
What does that have to do with the 11 million he owned before joining Elite ?
Direct or Indirect?
That proves nothing. He was paid for the ANDA's from Mikah.
He still owns the I series preferred shares.
Show me he converted those shares. He did not.
He is a direct owner of over 11,000,000 shares. Those were not given to him.
Please show us any doc, link or proof of any kind that he did not.
I'd really like to know.
Thanks for sharing.
Yet never any proof of otherwise or at least an alternate theory presented.
Phew!! That was an awful long "yes"!
Thanks!
So it's NOT possible to prove efficacy via 505b2 pathway using published literature or FDA findings?
These industry experts assert otherwise.
http://www.camargopharma.com/Userfiles/Why-505b2-is-a-Whole-Different-Animal.pdf
A 505(b)(2) application, on the other hand, is one for which
one or more of the studies relied upon for approval has not
been conducted by or for the applicant. In these cases, an
applicant may rely on published literature or on the FDA’s
previous finding of safety and/or effectiveness for the drug.
Heck even the FDA itself says so!
http://www.fda.gov/downloads/Drugs/Guidances/ucm079345.pdf
Section 505(b)(2) permits approval of applications other than those for
duplicate products and permits reliance for such approvals on literature or on an Agency finding of safety and/or effectiveness for an approved drug product.
I'm sure Camargo and Elite knows.
Glad we all agree that to prove efficacy does not necessarily require a phase 3 trial.
Whatever lit is required.
It is well known that efficacy can be proven without having to run an actual Phase 3 efficacy trial.
With 505b2 you can use published literature or FDA findings to establish efficiacy.
Interesting article about how the FDA is not so "rigid" as one may think.
Written by the Head of the FDA herself.
Why FDA Supports a Flexible Approach to Drug Development
Posted on February 6, 2014 by FDA Voice
By: Margaret A. Hamburg, M.D.
We all know that just as every person is different, so too is every disease and every drug.
Margaret Hamburg, M.D.And so we weren’t surprised by the results of a new study published in the Journal of the American Medical Association. The study found that FDA used a range of clinical trial evidence when approving 188 novel therapeutic drugs for 208 indications (uses) between 2005 and 2012. These results are entirely consistent with our regulatory mandate. We believe varying approaches to clinical studies to support drug approval is good news, not bad.
Data to support the approvals studied were based on a median of two pivotal trials per indication. A pivotal trial presents the most important data used by FDA to decide whether to approve a drug.
But when the authors looked more closely, they found that more than a third of these drugs were approved on the basis of a single pivotal clinical trial, while still other trials involved only small groups of patients for shorter durations. Of the approvals studied, the new drug was compared with existing drugs on the market only about 40 percent of the time.
The authors concluded that, based on these results, the ways in which FDA arrived at those approvals “vary widely in their thoroughness.” Or, in the words of one study author, “Not all FDA approvals are created equally.” Although I don’t think it was actually the author’s intent, a number of commentators framed this as criticism. But I would be more troubled if FDA used a rigid, “one size fits all” approach.
People with serious or life-threatening illnesses, particularly those who lack good alternatives, have told us repeatedly that they are willing to make some trade-offs in order to gain access.
And, of course, “thoroughness,” such as whether a clinical trial is large enough, is in the eyes of the beholder. There is no reason to expect drugs to be tested on similar numbers of patients, regardless of the disease.
Variation in approach to clinical studies demonstrates FDA’s innovative and flexible approach to drug development and approvals. Such an approach was specifically adopted by Congress in the Food and Drug Administration Modernization Act in 1997 and, most recently, in the Food and Drug Administration Safety and Innovation Act in 2012.
The FDA of today works with sponsors of new drugs to design a development and review pathway for each drug that best reflects the disease and patients it is intended to treat, the drug itself, and other treatment options. Some of the factors that enter into our calculus include whether the drug treats a rare or serious disease or addresses an unmet need and any previous knowledge we might have about the drug.
Thus, for example, FDA approved Imbruvica (ibrutinib), a treatment for mantle cell lymphoma, last year based on an “open-label, single-arm trial,” which means that every patient received the treatment and both patients and researchers knew they were receiving it. The results were compared to how well the 111 participating patients had responded to previous treatment for their disease.
And Elelyso (taliglucerase alfa) – for Gaucher disease – was an orphan drug approved in 2012 based on two trials with 56 patients.
In contrast, some trials require large numbers of patients to demonstrate a drug’s effects. This is often the case in studies in patients with a chronic condition such as cardiovascular disease, where larger populations are studied to capture treatment effects.
No matter what clinical trial design is chosen, the Agency always applies the same statutory approval standards of safety and efficacy to all drugs seeking to be marketed in the United States.
Increased flexibility does not mean abandoning standards, and it certainly does not mean abandoning science. Just the opposite. We need to employ the best science in ways that will increase efficiency, productivity and our shared ability to find creative solutions to the challenges that confront us.
At the end of the day, that is just smart regulation – ensuring that patients can more rapidly have access to the best that science has to offer.
Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration
- See more at: http://blogs.fda.gov/fdavoice/index.php/2014/02/why-fda-supports-a-flexible-approach-to-drug-development/#sthash.rJZJSBvr.dpuf
$7 billion, $8 billion...whatever!
How about that GLOBAL market!
The pharmaceuticals segment of the pain-management market is valued at $29 billion in 2007. It will be worth $38 billion by 2012 at a CAGR of 5.6%. http://bit.ly/1Ky2slU
Section 505(b)(2) expressly permits FDA to rely, for approval of an NDA, on data not developed by the applicant - such as published literature or the agency's finding of safety and/or effectiveness of a previously approved drug product.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069943.htm
Q4 2014 Results Earnings Conference Call July 1, 2014 12:00 PM ET
Unidentified Analyst
....I mean why don’t we do a reverse stock split or some kind of stock split. I don't know how you add more shares to a corporation without affecting the price.
Nasrat Hakim
Well, that's a longer discussion. First I am not going to have a stock split because the fundamentals does not support it right now. We will either organically grow back on to a NASDAQ or a major stock exchange or when we have fundamentals we’ll revisit whether we're going to have some kind of a stock reverse split. At this time I have no intention of looking at any of that. My focus is to get the products through the FDA, build some equity into this company and then evaluate the value of the company at that point.
Do you know anything about the standards for uplisting? You think a stock selling at .25 is eligible?
In due time.
This investor made no such assumption. But glad to see the transition from "promise" to "statement".
That's progress.
He said "We are on track to file".
He did not say "I promise we will file in December"
I personally would check before making an inaccurate statement.
To quote Bob Iger:
“Being religious about quality versus quantity has had a major effect on this company,” says Iger. “Nobody’s going to criticize you for bringing a great movie out late, but they will criticize you for bringing a bad movie out on time.”
No, in September Elite was "on track" to file. The FDA meeting in November changed that.
Faced with the choice of going with what they had and fulfilling the self imposed December date or waiting a bit longer with a greater probability of success they choose to wait.
Ever hear of adapting to changing conditions?
No, in September Elite was "on track" to file. The FDA meeting in November changed that.
Faced with the choice of going with what they had and fulfilling the self imposed December date or waiting a bit longer with a greater probability of success they choose to wait.
Ever hear of adapting to changing conditions?
That was then. This is now.
And I never took that as a "promise".
Elite was on track to file. The FDA requested more time. Elite could have filed in December but decided it was prudent to make the application as perfect as possible to comply with the FDA's wishes made in their November meeting.
MR. FRANGELLEONE: Okay. Finally, I met you in the Spring at one of the meetings. The big question I guess everyone is waiting on; do you have any confirmation on, if we need efficacy trial or not, for this particular NDA we’re trying to get pushed by December?
MR. HAKIM: And that is the subject that I have mentioned many, many times to everybody before. I went by the letter of the law and we have done everything that we believe the law requires. The FDA keeps coming back that they may want to see an efficacy and that’s what we’re negotiating with them. If they do, and as I’ve said, I have anticipated that they may ask for it; because if I was in the FDA there are certain things I may or may not ask for; and if they do, that is what I said; they will delay us a few months but they will not stop us because everything else we’ve done has been to their liking. And frankly, we are on the uphill of business and everybody knows, uphills happen as occasions for a hundred years. It’s not a matter of you’re going to say, in my opinion again, it’s a matter of going through the motions. So if they want us to go through the motions for one more thing, we will do it and we will do it right and we will get this approval.
And the great news for Elite is that; once we complete this first product, the ELI-200, and that’s why I’m focusing on it. Once we complete it, then we know exactly what the FDA wants for all the other products. So we start to go after them without having to wait for the FDA to tell us because they’ve already answered the questions for the first one. That’s why the first one takes the longest and it’s the hardest. Once we’ve established the criteria, we’ll move forward -- of all the others.
MR. SMITH: Okay. And the follow-up on that sir; when are we looking that we will be able to file everything?
MR. HAKIM: Trust me, we’re ready to file next month. But we are not in such a rush to file with the FDA and they come back three or four months later; “well you know, we really want you to do this one little thing;” it will take three or four months and end up delaying things badly. So, we are waiting for the FDA and they promise (to) expedite, to expedite things; to give us a clarity on what’s acceptable and what the, I shouldn't say what’s not acceptable because everything has been acceptable to them. It’s the fact that they've never seen any product like ours before and they may ask us for some enhancements or a couple of extra things. I've been frustrated and I bet you guys on it before; and once they make decision, that’s really what sets things in motion that will have a domino effect. It will happen one after the other.
This investor looks at it like this:
My return on my ELTP investment blows away ANY investment I could have made in PFE. Not even close.
Nasrat has delivered a far better roi than Ian.
Yes Ian reed is full of them
But they aren't