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Let me clear up the confusion
..with the option to add products in the future.
Elite Pharmaceuticals, Inc ( ELTP ) announced today the signing of a license, manufacturing, and supply agreement with Glenmark Pharmaceuticals, Inc., USA to market two Elite generic products in the United States with the option to add products in the future.
Next I started trying to track down the fed Tmax for oxycodone tablets, and it turns out that it is not public information, as far as I can find. But! I did find the fed Tmax for oxycodone capsules! I don’t understand the full history of how this happened, but somehow along the way a bunch of generic manufacturers started making oxycodone 5mg in capsule form and oxycodone solution with a different manufacturing technique. They were doing this without proper approvals and the FDA swept them all off the shelf at once, similar to what they did to us with Lodrane. Lehigh Valley (with Glenmark Pharmaceuticals) subsequently received approval for their two products via 505b2 NDA’s for a 5mg capsule- and a second NDA for oral solution. Both NDA’s use Roxicodone as a reference product.
no one has mentioned the state of SequestOx and related patents. If the compound has been reformulated is it still patent protected?
Prove it
By the way, I personally am not shorting this stock.
True, you can't make this up...
When has this stock EVER increased half that amount. Here is the reality, it hasn’t ever under Nasrat’s leadership after news has been released. But guess what? How did the stock fare after the SequestOx news? Reality bites. Followed by 2 more CRLs. There is a clear trend here and that consistency is what is being traded on. Stock has gone nowhere but south for months. Can’t make this stuff up.
Total bull.
I disagree. This stock is both predictable and with no buyers, is very weak. No updates from management continues the downward spiral. This sets up a situation for less risk for OTC penny stock short sellers.
If one can get an 80% chance of a 3-4% gain on a quick short selling trade, the margin requirements and rates are nothing.
This isn’t just an exchange of hands between MM’s dragging this down. This also isn’t a P&D, which crashes after the initial run up. This is retail turnover from selling + shorting + LPC dilution.
So post it....
Sadly, there is so much info lacking regarding how shorting actually does occur, sans offshore
Btw, a marketmaker is part of a registered broker/dealer and LPC is not a broker rofl
Thoughts?
shorting OTC stocks can be and is done in general through offshore brokers. This is not something new.
Pure sophistry.
It's been represented penny stocks cant be shorted or shorting penny stocks is cost prohibitive or shorting penny stocks is illegal
Yet, why would companies, such as Elite, insert such anti-shorting language in their purchase agreement with LP if the above is true??
Nope.
Stability testing takes time.
As of the last Q thy still hadn’t responded to the FDA regarding their concerns stated in the CRL and yet stated they “intend” to respond. I believe in CC mgmt clarified they prioritized the “avatar”
filing over Norco response.
US Generic Drug Approvals Tick Upward in March and April
Posted 18 April 2018 | By Zachary Brennan
2018 kicked off on a low note for generic drug approvals, but according to the latest activities report, the US Food and Drug Administration (FDA) in March began inching back to its fiscal year highs for approvals.
The decline in abbreviated new drug application (ANDA) approvals seen in January and February was attributed, at least partially, to the implementation of a new 1 January deadline for companies tracking elemental impurities. But those issues seem to have abated.
Robert Pollock, a senior advisor at Lachman Consultants, told Focus that he thinks the recent trend shows that the elemental impurities issue “appears to be less of a problem. I was a bit concerned the first 7 days in April due to very low numbers of approvals but April now appears to be in line with March approvals or even may even exceed March if the daily numbers for April continue.”
In addition to the growth in approvals in March and April, complete responses (CRs) sent in March also continued to decline, with less than half the number of CRs sent in March when compared to October 2017.
The updated figures come as FDA has released new considerations for applicants deciding when to submit elemental impurity data: One for ANDA applicants with a goal date in February and when the elemental impurity issue is the only outstanding deficiency, and the other for applicants with official goal dates in several months.
"In general, FDA recommends that any applicant who has not fully addressed elemental impurities in their applications in their current form submit the information as soon as possible," the agency said.
Do you have any guesses as to why Troxyca was discontinued?
ELI-201 Pilot Bioequivalence RLD = OxyContin?
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.
Referencing Approved Drug Products in ANDA Submissions
Guidance for Industry
January 2017
....
If an RLD appears in the Discontinued Section and FDA has not yet made a determination whether the drug was withdrawn from sale for reasons of safety or effectiveness, the applicant must submit a citizen petition under 21 CFR at the same time as the ANDA submission, seeking a determination whether the listed drug has been withdrawn from sale for safety or effectiveness reasons. Such petition must contain all evidence available to the petitioner concerning the reason that the drug product
was withdrawn from sale.
...
When selecting a new reference standard, FDA generally selects a drug product that is therapeutically equivalent to the discontinued RLD and is the market leader based on units sold.
...
If there is no reference standard in the Active Section of the Orange Book for a drug product the applicant intends to duplicate, the potential applicant may submit controlled correspondence to FDA asking FDA to select a reference standard for that drug product.
Uh, no.
Here is so real good news for Elite...
https://abcnews.go.com/Business/story?id=8186474&page=1
Glad I’m not short... hahaha
SEC Rule on 'Naked' Short-Selling Now Permanent
Associated Press
Published 3:15 PM ET Mon, 27 July 2009 Updated 12:11 PM ET Tue, 3 Aug 2010
Federal regulators on Monday made permanent an emergency rule aimed at reducing abusive short-selling, put in at the height of last fall's market turmoil.
The Securities and Exchange Commission announced that it took the action on the rule targeting so-called "naked" short-selling, which was due to expire Friday.
Truthful? Like the 21 Pathways to Dollarland?
Hmmmm. Let's check the data on that claim...
as i have proven, ER docs will not be significant prescribers of opioids
Oh really? Tell me the dirt. I love a good penny scam. Give me something to sink my teeth into. Need some fresh meat now that most of my other toys are pretty beat.
anti elite messages were everywhere
FDAs concern of abuse of Sequest was due to the IR ADF not delivering the intended pain relief timely, causing the user to take additional doses and increasing risk of over dosing
Big difference conveniently omitted
Assuming the tmax fix proves true, once approved, SequestOx will be the safest IR opioid.
Relatively speaking...
"SAFEST" IR in the World??? Maybe most difficult to abuse, but not safer than anything else in and of itself. One can just as easily OD orally...and given that this would prevent what some addicts crave, the fast, intense "high" then if they couldn't shoot/snort it, they would just take more at once, if they were abusers who didn't have another option. Safer than the acetaminophen apap if they took a handful, but that's about it. FWIW, I do think it would be desirable as an adf, but the claim of "SAFEST" in the world, please.
Which is why serious investors are not invested here.
For the most part, technical analysis is a joke, especially for otc junk stocks like Elite
I know what you mean about analysts being awful and biased... unlike internet boards and blogs, where everything is true, verified and completely unbiased.
And I guess if BA and PK change it will not affect at all the likeability... I mean if the opioid is released and absorbed quicker (due to the re-formulation) than the naltrexone it will have no effect at all in the euphoric effect and thus in likeability.
Cool, thanks for the info! ;)
So there is no source, no market analysis, no primary research... just showing that someone can do basic maths and make up random estimates.
Cool, thanks for the info! ;)
So you are saying the HAL study has NOTHING to do with the agonist bead?
I guess changing the formulation of the agonist excipients will not change its bioavailability and will not affect the pharmacodynamics and absorption of both drugs at all... good to know.
Can you post the source of this analysis so we can verify its authenticity and veracity to know where those numbers come from.
Regarding the HAL graph study you posted
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=139329422
can you please tell us if this study was done with the re-formulated SeqOx?
Guess like all bios it's wait and see. But wait another 5 years? Not me.
If it means SOx is dead, and to be replaced
they would also lose the deal with Epic, and with it, the milestone that was said to be necessary else may put us back as a "going concern."
Another Priority Review? I'd agree, possible but uncertain-
Just seeing the path forward is now a lot more murky than a simple coating fix for the T-max issue.
Opioids do not work! News at 11!
Now they tell us!
More importantly, however, are my other questions (and that is what they are--questions) regarding how a new formulation will be treated by the FDA with respect to being still under the SOx application waiver per the Priority Review, or if it means we have to do another separate application? And again, what are the implications with Epic and the milestone?
No new patent on the new formulation? I am surprised they don't have one if it really is that good...though would suspect that because they have been able to keep it to themselves, no need to disclose at this point, so that may not be an issue at all. Still, I would have still expected to see a patent at this point to ensure ownership exclusivity.
Can you share any details on the unique abuse deterrent formulations without SequestOx’s of Naltrexone that was included in the pilot study?
No, except to say, I am extremely excited about this formulation because it also is a platform that apply to all the IRs and it happened to be about maybe 10% of the cost. So we're extremely excited about this, but it's still too early in the next few months. Once Dr. Smith files a patent and we do a little more trials, we’ll update a little more about it.
Hahaha wow!!
Kempharm's studies show that there is a decrease in plasma concentration when *EIGHT* (8!!!) tablets are taken. In other words, not much help
I thought preventing dead by lowering the concentration in plasma was good... I guess I was wrong ;)
Pro-drugs are cute but not abuse deterrent
Example: KemPharm's Apadaz (prodrug of Norco). Received FDA approval last week after initially getting CRL due to lack of snorting abuse-resistance. As far as I can tell, the approval was given without any modification, but there is no ADF label. Unless they can figure out a market niche for a very expensive version of Norco without an ADF label, all they have is a new Oxaydo (no commercial viability).
Like most pro-drugs, Apadaz has some inherent overdose protection. Kempharm's studies show that there is a decrease in plasma concentration when *EIGHT* (8!!!) tablets are taken. In other words, not much help. Prodrugs are very finicky. Don't believe anything you hear until the data is available to prove it.
But, hey, why not accumulate for a few more years?
the seven year issue that was long ago resolved? ok got it
- What are those 'questionable' effects of Targiniq?
the pharmacodynamics of naloxone is certainly different as it is metabolised faster and bioavalability is variable, however, the abuse-deterrence of this antagonist still works.
'Abuse-Deterrent' Label Panned for New Opioid
by Kristina Fiore, Staff Writer, MedPage Today
July 24, 2014
The FDA has approved another abuse-deterrent opioid, although addiction experts said the drug can still be easily abused. The agency cautioned that the long-acting, extended-release opioid can still be abused if chewed and swallowed.
"Targiniq ER can still be abused, including when taken orally, which is currently the most common way oxycodone is abused," the agency noted in its press release.
That's because of the way naloxone is processed when taken orally, said David Juurlink, MD, PhD, a medical toxicologist at the University of Toronto. It can exert its effects on opioid receptors in the brain if injected into the bloodstream or taken intranasally. But when ingested, it's not absorbed well.
Chewing and swallowing will thus enable abusers to get the full 12-hour oxycodone dose all at once, said Andrew Kolodny, MD, chief medical officer of Phoenix House, a substance abuse rehabilitation program.
"This product is obviously inferior to OxyContin and should certainly not be labeled abuse-deterrent," Kolodny said. (Purdue Pharma also makes OxyContin.)
Lewis Nelson, MD, a medical toxicologist at NYU Langone Medical Center, noted that other opioid products containing naloxone, such as the addiction treatment Suboxone (a combination of buprenorphine and naloxone), have been subject to abuse "so the underlying assumption that adding naloxone to an opioid completely prevents abuse is potentially misguided."
"Since most abuse and overdose occurs through ingestion, and since this combination provides no risk reduction when taken by that route, it seems that adding the abuse-deterrent moniker is premature," Nelson said.
Addiction experts noted that the agency approved Targiniq without consulting an advisory committee, basing its approval instead on its review of the results of a trial involving 601 patients with chronic lower back pain.
"There's no justification for approving the drug without an advisory committee meeting considering how controversial the topic is," Kolodny said. "I'm almost certain an advisory committee would have voted this product down."
Now, regarding naltrexone and withdrawal symptoms... I'm sorry to say, but that is not caused by small amounts of naltrexone and certainly not by 'leakage'... that is the effect caused by manipulating these formulations and releasing either naloxone or naltrexone... and in fact, it is one of the main concerns among clinicians regarding these approach (opioid/antagonist) that abusers may suffer from severe withdrawal symptoms if they manipulate the formulations
Opioid withdrawal symptoms:
Pain areas: in the muscles
Gastrointestinal: diarrhea, vomiting, or nausea
Whole body: restlessness or sweating
Mood: general discontent or anxiety
Eyes: dilated pupil or watery eyes
Also common: cramping abdominal pain, fast heart rate, excessive yawning, goose bumps, insomnia, or tremors
More naltrexone should not be necessary... the concentration ratio of agonist/antagonist sufficient to block the euphoria induced by opioids is well know and it is what the current formulations use and any formulation scientist with good knowledge would use.
High concentrations of naltrexone in circulation also have effects on liver and kidneys, as it is metabolised slower and excretion takes longer.
2011 ???? lol old old news
dr_lowenstein Tuesday, 02/20/18 03:30:30 PM
Re: WeeZuhl
Post # 284273 of 284313
Really???? Got any evidence to support that old nonsense about embeda? Sheeeeze
dr_lowenstein Tuesday, 02/20/18 06:10:28 PM
Re: WeeZuhl
Post # 284298 of 284313
none of the links support anything about embeda instability