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What I learned today: ELTP isn't Penny Stock.
Interesting article, thanks for posting.
https://www.cnbc.com/2018/09/28/bank-of-america-cracks-down-on-penny-stocks-with-purchase-ban.html
After initially banning the sale of most penny stocks, the firm put the policy under review, allowing most of them to be sold for at least the time being, according to one of the sources. Only the riskiest penny stocks that already may be the target of fraudulent schemes — labeled with a skull-and-crossbones icon by the trading firm OTC Markets Group — can no longer be sold. Eventually, all penny stocks could fall under the restriction, the person said.
This security is exempt from the definition of a Penny Stock under SEC under Rule 240.3a51-1 because it meets one of the following tests: 1) A price of over $5 per share, 2) the issuer has Average Revenue of at least $6 million for the last 3 years, or 3) the issuer has Net Tangible Assets in excess of $2 million if the issuer has been in continuous operations for at least 3 years or $5 million if less than 3 years.
Weezuhl you are funny too... You are the only person I know who would attend an ADCOM for a company you have no vested interest in...
Hippocratic Oath
I swear to fulfill, to the best of my ability and judgment, this covenant:
I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.
I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin traps of overtreatment and therapeutic nihilism.
I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon's knife or the chemist's drug.
I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the skills of another are needed for a patient's recovery.
I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God.
I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person's family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.
I will prevent disease whenever I can, for prevention is preferable to cure.
I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.
If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.
People who live in glass houses shouldn’t throw stones.
Now could you answer the question from Fabius?
IPCI investors are funny.
Some investors are smart enough to see things before they are told. Some investors are smart enough to see things after they are told. Some investors never figure it out, ever, even after 90% of their capital is gone.
Regular readers know who is who. And I know all my retirement accounts and my kids' 529s are fully funded, and even if none of my speculative investments pay off, I'm still on track for an early, comfortable retirement. I also know I was able to use proceeds from my investments to help my wife quit her job and start her own business. I don't have to hide any of my stock purchases from her like some investors do.
I don't know how to be more clear...
On the other hand your assertions here that IPCI will not make Oral abuse because the drug can be chewed is ridiculous. You know better than that or at least should. The fact it can be chewed like bubblegum is not an issue. I already posted the guideline for oral abuse and being able to be chewed is not one of them. It comes down to how much of the drug is released upon manipulation such as pulverization, crushing, grinding etc. So as long as an acceptable amount of oxy is not released when chewed they will be fine.
I'm sure you are right, Samsa
So, as I have said and Mopar. it comes down to what the HAP studies indicate. I say chew it all you like as long as no OXY is released above acceptable standards it would get approved, it does not matter that its PEO based.
Exactly. Because it can be "chewed like bubble gum" doesn't mean it will dump it's dose. We won't know till after the results come in. Everyone else who says otherwise is speculating
Weezuhl- Xtampza has a food effect issue... That is why it is not commercially successful.
They are not better than Oxycontin.
Weezuhl- If the HAP results are good, partners will be lined up, if no partner, then we know.
That question will be answered by the HAP studies. Does it dose dump or not? Nobody knows yet.
Tilator- Take a look at what happened at PTIE Remoxy Adcom when they went in with good results and no partner and then get back to me.
Good old-fashioned silliness
1 If positive it will take a while to get the FDA to approved revised labeling and what company is going to do that? This is a study not supported by a company and they are the bodies that ordinarily purse FDA for labeling
2. If the results are positive and published, doctors could prescribe but no company can promote with the previously mentioned labeling.
3. The implications are that if a prescription is written for a generic, it wil be filled by the pharmacy by the then available generic, and that is likely to be the low cost alternative (ie, NOT elite)
4. If the market explodes as predicted then you the bps will come back in a heartbeat.
that is the defiant reality lol
No Norco
Looks like Norco to me
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
Notice how when Nasrat said, "we have not heard from the FDA yet", how it was forced and not in a normal tone of voice.
Psychology 101 says he is lying.
Anyone think this sounds familiar..This is an example of what goes on here in penny stocks
Anyone knowledgeable about the "poison pill" that NH has in place? Which of the two types do we have?
On November 15, 2013, the board of directors of Elite Pharmaceuticals, Inc. (the “Company”) declared a dividend distribution of one right for each outstanding share of our common stock and one right for each share of Common Stock into which any of our outstanding Preferred Stock is convertible, to stockholders of record at the close of business on November 15, 2013. Each Right entitles the registered holder to purchase from the Company one “Unit” consisting of one one-millionth (1/1,000,000) of a share of Series H Junior Participating preferred stock, par value $0.01 per share (the “H Preferred Stock”), at a purchase price of $2.10 per Unit, subject to adjustment. The description and terms of the Rights are set forth in a Rights Agreement (“Rights Agreement”) between the Company and American Stock Transfer & Trust Company, LLC, as Rights Agent.
2011 Mikah agreement to contract manufacture isradipine and phendimetrazine
Trepple did save the company and his dealings with Epic probably caused Nasart to create the poison pill to inhibit any back stabbing from within. Just a thought.
Ashok Nigalaye hasn't filed a Form 4 since he resigned as director more than 3 years ago. He could hold zero shares at this time and we would never know. Luckily, I couldn't give a rat's ass (other than I'm glad to be done with those Epic dudes).
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=142755556
Acting CEO Chris Dick and Treppel et al saved the company from bankruptcy with the Epic Strategic Alliance in March 2009. For this, think of the beginning of Braveheart where Longshanks rides with a heavily armed unit of cavalry into the middle of a wedding party and eats all the food and takes away the virgin bride to invoke his nobleman's right of Prima Nocta. For less than $4 million, Epic's three members ended up with three seats on the board and enough Preferred shares and warrants to ultimately, effectively control the company.
...we’ll see if it actually works and how long the road ahead actually is. Probably much longer than many here expect.
Footprints in the Sand (ELTP Edition)
One night I dreamed a dream.
As I was walking along the beach with Nasrat,
Across the dark sky flashed scenes from my life.
For each scene, I noticed two sets of footprints in the sand,
One belonging to me and one to Nasrat.
After the last scene of my life flashed before me,
I looked back at the footprints in the sand.
I noticed that at many times along the path of my life,
especially at the very lowest and saddest times,
there was only one set of footprints.
This really troubled me, so I asked Nasrat about it.
"Nasrat, I noticed that during the SequestOx CRL and reformulation failure,
there was only one set of footprints.
I don't understand why, when I needed you the most, you would leave me."
He whispered, "My precious shareholder,
I love you and will never leave you,
Never, ever, during our trials and testings.
When you saw only one set of footprints,
It was then that I carried you."
When I say I’m long, I mean loooooooong.
...Nasrat is pumping the brakes on SequestOx. Quietly slowing it down but not publicly saying so. Essentially he is pushing back the need for the $1+ million expenditure until revenue and/or share price increases.
O SequestOx, Where Art Thou?
Let’s first recognize the fact that Nasrat doesn’t need the FDA to tell him how to run a pivotal BE study. He’s done at least half a dozen since he’s been here, and he hasn’t gotten prior instructions from FDA on any of them. He can go ahead and do the study as he normally would, and worst case would be adding a few more subjects at the end if they want a bigger study. I don’t think this is true, but it is possible that the pivotal BE is already started and either ongoing now or already finished. It doesn’t sound that way to me when Nasrat discusses it, but he is awfully good at being coy when he wants to be. He usually only PR’s a pivotal topline result, not when the study begins. When he hears from FDA and he knows he has sufficient number of subjects, then he can drop the PR that pivotal BE is complete and resubmit the application (assuming nothing else is required). Again, I doubt this scenario, but I do think if the pivotal BE is not yet substantially complete, then there is a reason, and that reason definitely is not because we’re still waiting to hear back from FDA.
My best guess is that Nasrat is pumping the brakes on SequestOx. Quietly slowing it down but not publicly saying so. Essentially he is pushing back the need for the $1+ million expenditure until revenue and/or share price increases. “Just taking a little breather” is what I think, and the FDA makes for an easy target to blame for the delay. I also consider the possibility it is a hard brake on SequestOx. It could be an indication of the transition away from naltrexone ADF’s and towards the new, less expensive, patent-pending ADF tech. He already shelved the naltrexone versions of Percocet and Norco, and ELI-216 is seemingly permanently blocked by Troxyca’s failure to launch. One must ask: is this the end of the 2 bead antagonist ADF? I doubt it, but it might be. Another point to consider: of the ten drugs FDA-approved with an ADF label, five have never hit the market: Troxyca, Ventrela, Morphabond, Roxybond, and Targiniq. There is a problem in the ADF opioid market, especially for extended-release opioids not called OxyContin. As we see Elite filing ANDA’s for non-ADF opioids, CNS stimulants, antibiotics, beta blockers, etc., it is clear that ADF’s will be a less significant part of Elite’s future than previously thought.
So after all that, I admit I don’t know what the hell is going on with SequestOx, but I do know for sure there is more to it than just waiting for the FDA to tell us how to run a pivotal BE study.
Makes me wonder, how many of their actual generics have such a T-max issue, and if not, why the issue only with SOx?
Hmmm, I say. Why do oxycodone tablets show the Tmax for the oral solution? When you trace the data back to the original NDA, it very clearly states: “The food effect for the to-be marketed tablets can be extrapolated from the food effect on IR solution.” The tablets and solution were bioequivalent in the fasting state, but the tablets were not tested in the fed state. If the original Roxicodone tablets were never tested for fed bioequivalence, were any of the currently-marketed generic tablets tested for BE after a high-calorie meal? Does the FDA even know the fed Tmax data for the array of available tablets?
Does it make a difference? Is the fed Tmax different for the tablet vs. solution? After all, the brand name for the solution is OxyFast- maybe it really is faster. Isn’t that why abusers chew (or also “parachute”) their oxyIR/Percs/Norco- for faster absorption and quicker high. Maybe the fed Tmax of “Roxicodone tablets” isn’t as tidy as the FDA thinks, and maybe SequestOx is being unfairly judged against oral solution. Since Nasrat has never released the data, the controls used in ELI-200 studies are unknown. We know it was a three-way crossover (that sounds hot!) but not if any control formulations were tested in the fed state. “Three-way crossover” sounds to me like #1 Roxicodone fasting, #2 SequestOx fasting, and #3 SequestOx fed. This means that SequestOx failed to be bioequivalent to FDA data and not to an oxycodone “fed control” group run in crossover with ELI-200. In other words, SequestOx did not fail head-to-head, instead it failed against what the FDA deems to be the proper fed Tmax. This is very important, especially if the FDA data on fed Tmax is as sketchy as it seems.
SUMMARY
1. Original Roxicodone tablets were never tested (or at least never reported) under high-calorie fed conditions.
2. Every oxycodone tablet sold in U.S. carries a label that reports the food effect data (Tmax) of oral solution instead of tablet. It is unknown how many, if any, of the currently-marketed generic tablets were tested for bioequivalence after high-calorie meal. Many times ANDA applications are granted “in vivo waivers,” meaning their bioequivalence is assumed based on “in vitro” biochemical analysis.
3. Currently-approved oxycodone 5mg capsules have significantly slower Tmax compared with oral solution- double the Tmax effect and well-outside of the range of bioequivalence with oral solution. These capsules are not considered to have a food effect and do not carry instructions to take on an empty stomach.
4. Currently-approved oxycodone 5mg capsules have Tmax after high-cal meal of 3 hours. Bioequivalence standards require SequestOx to be within 125%, or 3 hours 45 minutes. If SequestOx fed Tmax is equal to or less than 3 hours 45 minutes, then it is already bioequivalent to Lehigh Valley NDA #200-534 and could be immediately approved in 5mg size if RLD is changed.
5. Lehigh Valley Pharmaceticals received Approval for oxycodone 5mg capsules, despite significantly delayed fed Tmax, without any food-effect labeling or safety concerns. The commentary which may explain why this was allowed has been redacted from the NDA’s Summary Review, which is signed by FDA’s Dr. Sharon Hertz. A Freedom of Information Act Request has been submitted by me for the redacted discussion.
6. While there is a significant difference in the effect of a high calorie meal on Tmax of oxycodone solution compared with capsules, there is no published data regarding the fed Tmax of tablets. In a three-way crossover pivotal BE study, it is unlikely SequestOx had any “fed control” arm with tablets. Nasrat likely has access to tablet fed Tmax data because of Elite’s work on Epic’s oxycodone tablet ANDA. This may be the kind of information he is collecting to show FDA.
7. Avridi used oxycodone tablets as a fed control, but the data is reported as “median” instead of “mean,” so it is not comparable to published data. Extrapolation suggests the mean is slower than the reported median for both Avridi and oxycodone tablets, but it was not suggestive of major Tmax difference between oxycodone tablets and solution. Based on my guesstimation, if Avridi reported fed Tmax as “mean” instead of “median”, it would look even worse, greater than 5 hours (and therefore outside the bioequivalence range of even the Lehigh Valley capsules). Avridi has detergent ADF, but SequestOx does not.
Keep up.
weezhul, again you make unsubstantiated claims. no one can say at this time if they will pass the oral abuse labeling standard. IPCI claimed they do. Naturally, I can not comment too much on what they prior claimed but they did claim they are oral abuse deterrent. Your slim reference to Odidi's claim that it can be chewed like bubblegum as a reason for not passing is immaterial. It does not matter if it is chew-able or not to be oral abuse deterrent, it comes down to the amount of opoid that is extracted. which none of us will know until they conclude all the studies will we?
Was this meant to be funny? It is.
The difference is, Odidi can be replaced, we still have promise in a nice pipeline. EGLT does not have much else going for it.
REPOST 12/2/17: Historical Milestones
For those who have been around for awhile (hi doc!), you may have already noted that we're approaching the ten year anniversary of Elite as a penny stock. The early years from 2000-2003 were tumultuous, mostly in a downward direction. Think Red Dragon where Dollarhyde lit the tabloid journalist on fire and sent him careening down the hill in a flaming wheelchair. Started at $14 with plans for 24 hour oxy and antagonist ADF. It hit the buck fifty range in a little over three years, by March 2003. That whole time period has been sent down the rabbit-hole and expunged from official history. No PR's exist in the elitepharma.com online archive dated prior to March 2003, and the first one is from the board saying the founder and CEO Mehta couldn't have quit because they had already fired him. The two sides settled for cash in exchange for the patents. When Mehta later sold out all his shares, it was around 1.3 million total, which is funny because I have a bunch more shares than the founder ever had. I'll have to check, but I think the authorized share count might have been a tad bit lower back then. Check out that earliest PR and you'll see somebody you recognize (hi Dianne!).
After Mehta came Buddy Berk. The share price remained volatile but overall bounced up and down off of a $2.00 base for years. Ten years ago this week on 11/29/07 it closed below 2 for the first time. Then it got ugly. For Elite in 2008, think Die Hard where Mclane throws Hans Gruber off the Nakatomi Plaza. January 2 was the last time it ever closed above $2, and just like that one month later it closed below $1 for the first time. March 26, 2008 was the last time it closed above one dollar, and as of that date in 2018, Elite will have been a been a penny stock for a full ten years. Buddy Berk got as far as getting a SPA from FDA for a Phase 3 study for ELI-216, what would have been the first ever oxycodone antagonist ADF, but by then the company was in no shape to do anything with it. September 19, 2008 it closed in single digits (.07), and by November 2008 Jerry Treppel was brought on to the board and Berk was out.
Acting CEO Chris Dick and Treppel et al saved the company from bankruptcy with the Epic Strategic Alliance in March 2009. For this, think of the beginning of Braveheart where Longshanks rides with a heavily armed unit of cavalry into the middle of a wedding party and eats all the food and takes away the virgin bride to invoke his nobleman's right of Prima Nocta. For less than $4 million, Epic's three members ended up with three seats on the board and enough Preferred shares and warrants to ultimately, effectively control the company.
Barely breathing, Elite was delisted from Amex in May 2009. Treppel was named CEO in November 2009, and he became like Travis Bickle in Taxi Driver, ensuring the survival of the tough but vulnerable young prostitute Iris, who every day does whatever is necessary to survive, no matter how low. Treppel moved the company toward generics, starting with methadone in 2009. The next year, Elite purchased the naltrexone ANDA from a company called Mikah Pharma. I'm sure with a funny-sounding name like that, we'll probably never hear anything more about them.
It's a miracle this company didn't go bankrupt in 2008 or 2009. But it didn't. It's like in Stranger Things, when Eleven uses her power to stop Mike in midair as he free-falls off the cliff and toward the bottom of the quarry. An Epic survival, literally, mainly on the back of Lodrane-24D, an illegal decongestant with enough stimulant to suck every secretion dry until your mucus membranes are fully-desiccated and you can't pee or poop right for a week.
I bought my first shares on May 10, 2011, 10,000 shares at 14 cents. Soon thereafter the FDA pulled Lodrane-24D, and I got my first taste of life as part owner of Elite Pharmaceuticals. Treppel transitioned the company from survival to growth, and handed the baton to Nasrat Hakim. It's hard to imagine everything that has happened since then. How far we've come but how little we have to show for it. But the antagonist ADF tech the company was originally based on was way before its time. Even now, with the opioid epidemic in full bloom, we still allow kids to snort non-ADF IR opioids like oxyIR, Norco, and Percocet. It never had a chance in the early 2000's, which was years before anybody ever heard of OxyContin, Hillbilly heroin, or pill mills. If ever there was a time to commercialize the original ADF tech, now is it. Elite has ready-to-go antagonist ADF versions of Norco and Percocet, and as always, the ADF oxyIR version should be ready to go soon. Maybe someday somebody will decide we ought not to let kids snort this crap. After all these years, Elite is ready for that day to be today.
Elite's filed and pending ANDA's
1. Methadone
2. Norco
3. OxyContin
4. Adderall
5. Concerta
Oh my. Percocet approved and launch is imminent. Three-year isradipine Phase 3 study finishing up this fall. SequestOx moving forward. New ADF tech development. Good time to own shares.
A majority of scripts for ADHD are for longer-acting drugs, like Concerta and Focalin XR, but Adderall immediate release remains well-liked.
Elite is well positioned for Success
Elite has 6 ANDAs filed and will be filing one a quarter going forward.
One Approval a quarter expected.
Elites 2018-2019 DollarLand Catalysts
Elite Pharmaceuticals And SunGen Pharma File ANDA
NORTHVALE, N.J., Feb. 08, 2018 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of an immediate release CNS stimulant. The ANDA represents the first filing for a product co-developed with SunGen Pharma, LLC ("SunGen") under the Development and License Agreement ("Agreement"). According to IMS Health data the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ending September 30, 2017.
Weezhul, clearly you just pick and chose what you want to believe to push your agenda. The Company stated they were exploring partners and offers. The fact they did not accept any you use as proof they didn't have any? there is a big difference of not accepting a deal and never having one.
Weez, you ask for the evidence to back up my statements yet you then do the exact thing. You make a statement saying no one is interested in Rexista or Regabatin. why do you make that statement? merely because no partnership has been signed yet? the company even stated they were exploring interested partners.
As to my proof, its simple. The warrants are now classified s shares and they increased the outstanding shares. that places them on the books which means shareholder equity. Just go back and read the PR associated with the with resale.
1. they already are set up to meet compliance. the recent reclassification of the previous warrants into shares now gives share holder equity.
Isradapine Parkinson’s 3 year $23 million dollar Study
The problem with DHPs from a therapeutic perspective, however, is that they are not selective12. LTCCs are a heterogenous class of multi-subunit ion channels13,14 that can be divided into four classes based on the identity of their pore-forming alpha 1 subunit, CaV1.1-4. This pore-forming subunit governs key features of the channel, including gating and pharmacology. The predominant (~90%) LTCC in the brain has a CaV1.2 subunit; this channel also is abundant in a variety of peripheral organ systems, including the cardiovascular system and is effectively antagonized by DHPs, accounting for their therapeutic efficacy in hypertension15. However, the LTCC responsible for mitochondrial oxidant stress and increased vulnerability in SNc dopaminergic neurons is largely attributable to expression of LTCCs with a CaV1.3 subunit5,6. Among the DHPs, isradipine has the highest relative affinity for CaV1.3 LTCCs, but it is still CaV1.2 LTCC selective14. This diminishes the therapeutic potential of DHPs in PD, as cardiovascular side effects limit the dosing and antagonism of CaV1.3 LTCCs.