Second Best Month for Unofficial $ELTP Blog

Please take notice of the upward moving trend for viewing this blog since it's inception in early 2011.
Plenty of data here, folks, and what you're seeing is some dips and peaks, but most significant was the huge spike in December 2015.
This month has brought in a nice tidy sum to earn 2nd place, all-time.  Higher lows and nice upsides.
Doesn't mean much, no paid ads, but if this continues, you may help supplement my income, so keep visiting.

Meanwhile, as goes $ELTP the company, so goes the $eltp Unofficial Blog.

Those Bunionectomy Studies

https://clinicaltrials.gov/ct2/results?term=Bunionectomy&Search=Search

How ART Works

Elite’s proprietary abuse-deterrent technology, ART™, is a multi-particulate capsule which contains an opioid agonist in addition to naltrexone, an opioid 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-deterrence can be applied to a wide range of opioids used today in pain management.

So Now You Know The Story in May

ELITE PHARMACEUTICALS (OTCMKTS:ELTP) Shorted Shares Increased By 148.48%

Todd MillerMay 15, 2016

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The stock of ELITE PHARMACEUTICALS (OTCMKTS:ELTP) registered an increase of 148.48% in short interest. ELTP’s total short interest was 106,100 shares in May as published by FINRA. Its up 148.48% from 42,700 shares, reported previously. With 704,700 shares average volume, it will take short sellers 0 days to cover their ELTP’s short positions. The stock increased 2.26% or $0.007 on May 13, hitting $0.317. About 912,846 shares traded hands or 29.98% up from the average. Elite Pharmaceuticals Inc (OTCMKTS:ELTP) has risen 45.45% since October 8, 2015 and is uptrending. It has outperformed by 43.81% the S&P500.
 LINK TO ARTICLE

TRANSCRIPT: Both Elite Pharma AND Dr. Setnik are referenced and quoted.

Interesting transcript. Both Elite Pharma AND Dr. Setnik are referenced and quoted. 
 
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM428296.pdf

Just info to chew on as we wait for July 14th!

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One that could be seen at a pretty high level
17 is separate multiparticulates for antagonist and
18 agonist in a technology like Elite Pharmaceuticals
19 are developing, or the agonist and sequestered
20 antagonist in the same bead, like Embeda.

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DR. SETNIK:

Mine's fairly easy, too. Thank
17 you for the opportunity to speak today. My name is
18 Beatrice Setnik. I'm with INC Research. I'm a
19 former employee of King Pharmaceuticals and Pfizer.
20 The opinions are my own, and I'm not being paid to
21 speak today.
22 I wanted to thank the FDA for this


1 opportunity to speak. I commend the FDA for
2 standardizing, or attempting to standardize, the
3 in vitro approach, as I think this will enable
4 sponsors to be able to come up with a consensus on
5 how to test in vitro products.
6 My concerns do lie with the attempt to
7 correlate in vitro to in vivo testing. When we look
8 at bioequivalency on the terms of efficacy, we are
9 dealing in a more simplified fashion. You have an
10 in vivo study. You have two endpoints on which you
11 establish bioequivalency. In the in vitro setting,
12 you're discussing the potential of looking at
13 various solvents and different conditions, with the
14 possibility of having upwards of a hundred different
15 testing conditions.
16 Not only do you need to standardize the
17 definition of how you define bioequivalency or
18 equivalency from your test to your reference
19 compound on each individual condition, but then be
20 able to define bioequivalency across a multiple of
21 almost hundreds if not more of actual testing
22 parameters, which in itself is a challenge.


1 Given the infancy of this field, and this
2 challenge is enough, which will be to standardize
3 across different products, the definition of what
4 will be bioequivalent is in itself another
5 challenge.
6 Not only do you have these confounders, you
7 have the variability in manufacturing which will
8 cause differences. The sheer number of conditions
9 in which you're testing statistically will pose a
10 high likelihood that you will not have two products
11 that will look identical in a panel of batteries
12 that are as extensive as what one tests in an
13 in vitro panel.
14 Furthermore, you will need to contend with
15 the fact if there are 90 percent homology,
16 95 percent, how well that be interpreted? How
17 will that be defined as equivalent to a reference
18 product? And furthermore, as has been stated
19 earlier, there have been cases where in vitro data
20 can be different from in vivo. So one has to be
21 cautious in the interpretation of what a
22 bioequivalent standard in an in vivo paradigm would


1 translate to in terms of in vivo.
2 Certainly when we do establish bioequivalency
3 to efficacy, we do so by testing in in vivo
4 conditions. We don't look at dissolution to
5 establish clinical efficacy in terms of
6 bioequivalence. And the same nature of this
7 conundrum would apply to the abuse-deterrent
8 formulations in itself. So I caution the committee
9 and the FDA to be careful about labeling claims on
10 an in vivo nature simply based on in vitro
11 paradigms. I think the science is too young for
12 this.
13 The second, I also wanted to point out that
14 with in vitro testing, the time component and the
15 complexity are two very important factors. A third
16 component is the toxicity, and also looking at the
17 different solvents that may be used, and what
18 toxicity and safety implications may be from using
19 different types of manipulation techniques.
20 The third point I also wanted to make was
21 that generally, abuse is a dynamic process. And
22 although we look at the types of behaviors that are


1 engaged today, these behaviors will change over
2 time. Certainly as more ADFs come to market, the
3 behaviors of the abusers will change over time.
4 Hays pointed out in a study that abusers over a
5 course of 19 months went from oral to intravenous
6 use. Individuals change. The trends change.
7 We also need to, as we are developing these
8 products, not only think about what routes of
9 administration are relevant today but also what will
10 be relevant tomorrow in the future years, as we are
11 dramatically changing the landscape of the abuse by
12 introducing ADFs potentially into the marketplace.
13 My last point is really the uptake and the
14 success of these types of products really will be
15 dependent not only on uptake of this, but also
16 understanding the limitations and the important part
17 that they play as a tool with other management of
18 careful risk evaluation and management in the clinic
19 setting of patients.
20 Not only do patients, providers, and
21 manufacturers need to play a role, but managed care
22 will also need to embrace the concept and play a


1 part in terms of promoting the safe and effective
2 use of opioid medications in the population. Thank
3 you.

Four Reasons For $ELTP

1) Elite Announces U.S. FDA Priority Review Designation For SequestOx™ NDA
http://ir.elitepharma.com/profiles/investor/ResLibraryView.asp?ResLibraryID=80708&BzID=2258&t=1948&g=939&Nav=0&LangID=1&s=0
The FDA has set a target action date under the Prescription Drug User Fee Act ("PDUFA") of July 14, 2016.

2) FDA to reform painkiller approval process
http://www.reuters.com/article/us-fda-califf-idUSKCN0VD2MJ
Bowing to pressure from lawmakers, Dr. Robert Califf, President Barack Obama's nominee to lead the Food and Drug Administration, said on Thursday the agency would reform its process for approving opioid painkillers.
The FDA said in its announcement it would develop additional safety information for immediate-release opioid painkillers; strengthen the requirement for drugmakers to produce information after a drug reaches the market; and expand access to abuse-deterrent opioid drug formulations.

Quote:
3) ADF Supported
 http://abusedeterrent.org/news/MAJORITY-OF-PUBLIC-SUPPORTS-REQUIRING-ABUSE-DETERRENT-FORMULATIONS0aIN-MOST-ABUSED-PRESCRIPTION-DRUGS0a.aspx#.VuvYJXg39FJ
McLean, Virginia. A new national survey reports 65% of adults in the U.S. believe the Food & Drug Administration should require pharmaceutical manufacturers to include an abuse deterrent formulation (ADF) in all of their most abused drugs, both name-brand and generic.
With the United States facing its worst prescription drug abuse problem ever, the emerging new technology of ADF’s helps prevent the crushing, snorting and injecting of prescription painkillers when abusers are seeking an immediate high. The FDA has approved labels for 5 Schedule II drugs with abuse deterrent properties, and 9 states have passed legislation related to ADF prescribing, but with no national mandate in place, it is easy for abusers to switch to prescription drugs without an abuse deterrent formulation.
Two-thirds of U.S. adults would also support legislation introduced in the U.S. Congress to mandate that pharmaceutical companies place abuse deterrent formulations in their products within the next four years.

Quote:
4) Physicians call for novel abuse-deterrent opioid agonist/antagonist formulations in survey
http://www.fiercedrugdelivery.com/story/physicians-call-novel-abuse-deterrent-opioid-agonistantagonist-formulations/2015-11-09
A survey of more than 200 physicians found that 31% think opioid antagonists is the abuse-deterrent formulation that is most needed to combat the opioid abuse epidemic--an issue that's been implicated in the startling rise of the death rate of middle-aged white Americans without a college degree.

What type of abuse- deterrent formulation is most needed?
Number (out of 214 respondents)
Opioid antagonist/agonist combination 66 (31%)
Physical or chemical barrier 48 (22%)
Novel delivery system 34 (16%)
Aversion 33 (15%)
Prodrug 14 (7%)
Other or combination of above 19 (9%)
FierceDrugDelivery supplied the question to Quantia MD, the provider of a physician engagement platform that counts one-third of U.S. doctors as its members.

Out of 214 physicians, 66 said opioid antagonists/agonists are the most needed formulation. Opioid antagonists are substances that interfere with the euphoria associated with drug abuse. The deterrents would generally be released and activated only if the product is manipulated, such as during crushing or snorting.

Elite MENTIONED In Opioid Article!

Government Spending On Opioid Epidemic Creates Surprising Beneficiary

Thursday,April 28,2016

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On March 22, 2016 the Food & Drug Administration (FDA) said it would require opioid painkillers to carry a black box warning, as part of the U.S. government’s response to curbing the opioid epidemic [1]. Overdose on prescription painkillers like ‘Percocet’, ‘Oxycotin’, ‘Vicodin’ and illicit heroin, combined, led to nearly 26,000 deaths in 2014. Critics, however, say it may be “too little, too late” and point to the failure of the black box warning instituted in 2004 for anti-depressants, suggesting the label change is unlikely to adversely affect major opioid drug makers like Purdue or Endo, or newer entrants like Pernix or Elite Pharmaceuticals.  READ THE REST

Huge Questions Loom For Elite Pharmaceutical Future

When will the FDA release it's decision might be the least cloudy question that can be asked.  We know the answer is sometime in June.  The FDA has set a target action date under the Prescription Drug User Fee Act (“PDUFA”) of July 14, 2016 for SequestOx.  So any time between now and then investors will get news on the FDA's decision.  What happens next could be huge in either direction, and has a everyone calling shots on the message boards.  As long-time investors and shorts and naysayers duke it out the one thing that's missing is information from neutral, reliable sources on what kind of outcome looms.  There have been some unreliable "valuations" of the company but for every pie in the sky comes a dose of grounding commentary to be considered.  For every stand-tall comment comes a STFU and vice-versa.