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Still, more than 10 years and nothing approved, no other companies approached Elite to use their technology, interest in the company is only strong in this forum
if this technology works, the preliminary results would be out already, but it has been more than 10 years and nothing
The judge didn't sided with Pfizer, because the litigation was dismissed by both parties... in fact, if anything, it was in favour of Watson because the litigation was dismissed with 'prejudice', which means Pfizer cannot sue Watson again for this.
Maybe if you read more about this deals you would realise how this works, because Watson/Actavis/Teva are the manufacturers of Embeda for Pfizer, they are and have been for the last 8 years, so the deal just brings money to Teva while they pursue their ANDA.
If you haven't seen an approval yet it is because Embeda was discontinued in 2011 until 2015, then it got its AD label in 2015... so other things happen thru these years that delayed any Gx Embeda
and as a note for all of those who wonder why there are no Gx ADFs yet, it is because FDA is waiting for the post-marketing studies from the current branded ADF to prove they work before they go and approve generics ;)
One of the factors that the FDA would consider relates to generic access. We must have the potential to improve access to the newer formulations, for appropriately selected and monitored patients, through the introduction of generic competitors.
In order to support this transition and encourage advancements in this area, today the FDA issued a final guidance to assist industry in their development of generic versions of approved ADF opioids.
General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products
Guidance for Industry
November 2017
As a matter of fact, the litigation was settled by both parties as they reached an agreement (you can see this in the litigation history), additionally, in 2016 (during an investors presentation) Teva presented Embeda as a product they had confidentially settled and would be launching when exclusivity ends.
Not that interesting, it is a well known fact that Watson (now Teva) filed for Gx Embeda back in 2011, and so far they are the only ones.
and with the exclusivity expired the approval can happen any time
In a one page order, Judge Andrews adopted plaintiffs’ proposed construction, construing the term “sequestering subunit” to mean “Any means for containing an aversive agent and preventing or substantially preventing the release thereof in the gastrointestinal tract when intact, i.e., when not tampered with.”
They should just buy the ANDA that their good friend Epic already has ;)
If Elite's filing hasnt been sued/under litigation, it may indicate that they filed thru paragraph 3, as Oxycontin still has one patent that prevents ANDAs approvals.
so if Elite filed thru Para 3, that means they won't launch until 2025, when the remaining patent expires
otherwise generics face much more competition and price disadvantage than branded products... even with generics in the market branded products can retain a significantly profitable price and a considerable market share
Smart pharma companies do not rely on their "pending" products to play with their stock price, but instead in having an attractive and constantly evolving R&D pipeline to attract new and big investors.
Elite's attractive selling point was (WAS) their dual bead (opioid/ant) system, however they haven't learn how to exploit it and as I said before, by the time any of these get approved it will be obsolete.
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.
CC Question
Elite's generic Oxycontin ANDA was submitted on Sept 20, 2017. Has the application been accepted for review by FDA? If so, has Purdue been given Paragraph IV notification? If so, when was it given and has there been any official or unofficial response from Purdue? Are there any human abuse liability studies that have been done yet or are scheduled to be done for Elite's generic version of OxyContin?
Don't forget PODRAS is totally useless to prevent oral abuse or suicide, even if it works as is intended, which it won't.
lmfao!!!
Q:How do you abuse any drug with PODRAS?
Q:How do you kill yourself despite PODRAS?
I stand corrected.
In fact your own follow up statement you're using as proof doesn't even say "chewed like bubblegum" it clearly states "become like bubblegum" oops!!!
BTW, don't forget that Dr. Odidi himself said Rexista can be "chewed like bubblegum."
BTW, don't forget that Dr. Odidi himself said Rexista can be chewed "like bubblegum."
Nobody still here has lost 1 dime WeeZuhl...
also your 2nd paragraph about the removal of the blue dye being the only oral abuse deterrent in regards to chewing is bs...and where did Dr. Odidi supposedly ever say that Rexista could be chewed like bubblegum? That's a bs claim to>>>
What we have designed makes it so that, yes you can go ahead and crush the tablet, however if you crush the tablet, all the moisture content will suddenly gel… they form a very strong gel and become like bubblegum, therefore, you can’t snort them and you can’t dissolve them to inject them. That’s what we’ve done, that’s the area we’ve gone into.
Well now, that was interesting thing to say. Rexista can be readily crushed (and therefore chewed). I always thought the blue dye #1 was a superfluous add-on marketing gimmick in order to differentiate Rexista from the other physiochemical oxycodone ADF's. But apparently the blue dye is a necessary add-on due to Rexista's lack of crush-resistance. That's a problem not even I anticipated. Just wow. Now we know why the HAL studies are top-secret. LOL, Rexista is "like bubblegum." Delicious, delicious bubblegum. Spearmint my ass, where's the Rexista??
Physico-chemical studies suggest that Rexista™ oxycodone:
should be difficult to abuse through crushing, chewing or licking
release of oxycodone is likely to be slower or not instantaneous in a range of beverages and solvents (Ed. Note: does not prevent chewing)
should not "dose dump", or instantaneously release the entire dose of oxycodone, in the presence of ethanol over a range of concentrations (Ed. Note: does not prevent chewing)
when pulverized and reduced to particles, should be difficult and time consuming to syringe or inject in the form and volume suitable for intravenous administration (Ed. Note: does not prevent chewing)
when pulverized or reduced to particles, should be difficult or inefficient to snort or inhale (Ed. Note: does not prevent chewing)
release of oxycodone should be insignificant or inefficient via heating and vaporization (Ed. Note: does not prevent chewing)
extraction of oxycodone which has been microwaved should be difficult or inefficient
(Ed. Note: does not prevent chewing)
Results from accelerated stability studies indicate that the Rexista™ oxycodone formulation is stable even at a high temperature (40°C) and relative humidity (70%) of storage. (Ed. Note: does not prevent chewing)
Based on the meeting, the product candidate will no longer include the blue dye.
“The FDA approval of the sNDA is a major milestone for Collegium. With the addition of comparative pharmacokinetic data with OxyContin and an oral abuse deterrent claim, Xtampza ER is the only single agent oxycodone with oral, intranasal and intravenous abuse deterrent labelling,” said Michael Heffernan, CEO of Collegium.
Welcome Winechemist.
The test products included two formulation modifications of SequestOx, a unique abuse-deterrent formulation without sequestered naltrexone, and a reference product.
I am wondering what this formulation could be, this seems very interesting.
Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today reported positive topline results from a pilot study conducted for SequestOx™, Elite's immediate release Oxycodone Hydrochloride product that incorporates its proprietary abuse-deterrent technology.
SequestOx is Elite's investigational abuse-deterrent immediate-release oxycodone product with sequestered naltrexone for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The study was a Phase 1 pilot, randomized, single-dose, single period, pharmacokinetic study in healthy male and female volunteers in the fed state. The test products included two formulation modifications of SequestOx, a unique abuse-deterrent formulation without sequestered naltrexone, and a reference product. The following table summarizes the Tmax results for the pilot study.
Nailed it!
SequestOx Tmax
Treatment-----N---median---min---max
Reference-----12---2.25---1.28---5.00
Test-A----------12---2.5-----1.25---5.00
Thanks steadyhand. Good eye.
The figure you cite is better than 3D cell culture (which is a pretty tacky method). The figure you cite is from an orthotopic mouse model (tumor model). Notice the Y axis is tumor weight in grams.
Reasonable question.
The reason I say all of this is because I don't see how you can you simulate the mechanism of action in a 2D or 3D culture environment. Prolanta works via autaphagy as a result of human prolactin receptors (hPRL) being antagonized. How could a 2D or 3D culture possibly create a scenario that involves hPRL receptors? Prolanta is fighting cancer in an indirect manner.
Prolanta is fighting cancer in an indirect manner.
Recent studies have shown that levels of PRL were substantially
elevated in ovarian cancer patients and concomitantly
enhanced proliferation, migration, and invasion and promoted
tumor angiogenesis (Asai-Sato et al., 2005; Levina et al., 2009).
Our results indicate that antagonism of PRL/PRLR axis enriched
late-stage autophagic vacuoles in cancer cells cultured in 3D
conditions, which led to programmed cell death. This might
explain the robust inhibitory effects of G129R on tumor growth
that we observed in vivo, but not in 2D cultured cancer cells.
Yes.
is Vyvanase an extended release product?
Sorry, I should have been more specific.
yeah, probably crestor. what, about 30 companies already w approved generics, wow, this is a real blockbuster LOL no wonder they didnt disclose
and the attention-deficit drug lisdexamfetamine dimesylate (Vyvanse, Shire), at about 10.6 million.
what is the undisclosed drug in today's news?
Through June of this year, the cholesterol-lowering drug rosuvastatin (Crestor, AstraZeneca) was the most prescribed branded drug in the United States, and the arthritis drug adalimumab (Humira, Abbott Laboratories) was the best-selling branded drug, according to the latest data from research firm IMS Health.
Rosuvastatin had about 21 million prescriptions, followed by asthma medication fluticasone propionate/salmeterol (Advair Diskus, GlaxoSmithKline), at about 13.6 million prescriptions; the proton pump inhibitor esomeprazole (Nexium, AstraZeneca), at about 13.2 million prescriptions; the insulin glargine injection Lantus Solostar (sanofi-aventis), at about 11.2 million; and the attention-deficit drug lisdexamfetamine dimesylate (Vyvanse, Shire), at about 10.6 million.
Is today opposite day?
Funny thing is, "progressing" was my word choice that I decided to use when paraphrasing our conversation. She actually said that all of the patients were "improving". I forgot that in the world of cancer 'progress' is a negative word as in the cancer is progressing to a worse state. You obviously knew I was trying to say though.
Are you thinking of the word "regression"? LMFAO
"Progression" is bad.
I asked her about the efficacy of the drug, and she told me that every patient that was tested had progressed with their conditions and it's a shame that they had to stop the trials.
...
All in all, I would say it was a positive phone call and is in line with a lot of what we already knew. It sure made me feel good to hear her say that ALL of the patients were progressing.
Nah...take .09 and run. Nobody cares.
During the last cc they mentioned they had 30 days to respond to FDA on Perc and Norco. I assume Sungen product got delayed. I am ASSUMING they responded in time. Nasrat clearly mentioned that if they didn’t respond timely they would have to get in the back of the line...
Let me try this into our pending applications to-date. We have filed four ANDAs, Oxy APAP, Hydro APAP, non-disclosed and OXY ER. We received a complete response letter that defined exactly what more does the FDA want. The requirements range from, A, make a commitment that you can comply with elemental analysis which will become the law of the ANDA in 2018. We did. Provide the additional testing for certain things. We did. Do a micro on the specific things. We did. We just filed our response to FDA’s complete response letter for OXY APAP and we will file the response to Hydro APAP hopefully within the next couple of months.
FDA has hardly asked a single question about the undisclosed application the last night. Late p.m. yesterday they sent us the inquiry asking a host of questions and gave us 30 days to answer them. We have not received any inquiries yet on Oxy ER.
Just to put things in perspective for you. During Q4 of this year, in addition to having to prepare to file and we will file the SunGen application in December of this year. In addition to that, we have to response to the FDA for Oxy APAP. We are responding for Hydro APAP and we are responding for our undisclosed, all within couple of months, that’s a huge burden on the staff especially when the FDA give this specific time you get to respond in 30 days or you are in the back of the line, okay. So we are doing a lot of work in here and this is why it takes a little bit of time to put the response together and sent it to FDA.
Where is this info from?
I believe Perc was for the minor amendment that should be remedied quickly. Knowing they replied to the FDA by mid-December, I would hope to hear an FDA response by early Feb - about a week before the quarterly conference call.
"Elite is considering strategic options, including divestiture, for this newly approved ANDA."
What does this mean?
I'm sure there's a good reason why a company seeks and gets approval for an ANDA they already own. I can't wait to hear what this is about.
The Phendimetrazine Tartrate approval is from an Elite ANDA filed approximately six years ago. Since the filing, Elite obtained a second, approved Phendimetrazine Tartrate ANDA through Mikah Pharma. Elite has been selling this generic product for more than five years. Elite is considering strategic options, including divestiture, for this newly approved ANDA.
“An ANDA approval for Phendimetrazine Tartrate at the end of 2017 was a welcome occurrence,” commented Nasrat Hakim, President and CEO of Elite. “We look forward to additional approvals in 2018 from more recent filings."
Peter, A Boy, and a Wolf.
The "story" they sold to the investing public was Tmax and how ELTP would capture a huge market share.
But that story has gotten old. The proverbial Peter crying Wolf too many times.
Funny.
I can't recall seeing this before. Usually when a merger results in one company owning duplicate ANDA's, then the new company agrees to divest the extras. That's how Nasrat got Mikah's 13 ANDA's for his basement pharma. I'm sure there's a good reason why a company seeks and gets approval for an ANDA they already own. I can't wait to hear what this is about.
Weird.
Elite's "Bontril" has been around for years now. Don't know why this got posted by the FDA as new approval
I appreciated it.
Someone is dumping 100k block then propping the Ask back up with 250 shares?
Manipulation at its finest
09:41:20 0.048 100000 OTO
10:34:44 0.0569 250 OTO
What's your point?
Elite apparently felt the Warning Letter qualified as a material event by disclosing it in an 8K filing with the SEC last year
Is it now being suggested the poor optics it could create, by reminding the public of the past Warning Letter, now trumps public disclosure at Elite?
why has there been no PR from the company about the apparent lifting of the warning letter?
I'm shocked, shocked I say.
LOI with CORE Tech
Letters of intent with Generex are sort of like my intent to exercise. Good ideas, but nothing ever happens.
The parties discussed a restructuring of the LOI, but decided to discontinue discussions for now with a view to revisiting the transactions contemplated by the LOI at a later date. On December 8, 2017, Core-Tech confirmed formal termination of the LOI.
WeeZuhl
I have appreciated and respected your contributions to this board for as long as I've been reading it, however, my critical comments regarding ELTP are spot on. I can accept your criticism, but I submit you focus on ELTP as a whole rather than in an optimistic, narrow scope.
I contend:
Management failed to navigate the approval process in a timely and strategic manner. This failure in management has caused an indefinite delay for SequestOx. This delay substantially devalues the technology and makes it nearly impossible for ELTP to sell and market it. Too many years have passed.
But what I was trying to express is that Elite started an ADF company multiple years before OxyContin came out. It would be nine more years until the movie OxyContin Express won the Peabody for documenting the craziness in Florida. By then, Elite had been less than a dime for nearly two years. ADF OxyContin didn't come out until 2010, and before that nobody ever heard of an ADF label. A lot has changed since then. We have a whole new language for describing ADF properties, testing for effectiveness, and certifying the label. My bet here is that it is worth something to have a unique ADF tech that can readily meet the requirements for chewing, snorting, and IV abuse deterrence labels for any opioid agonist and any time-release characteristic (even if it isn't first and isn't revolutionary).
Steaming bucket of hooey.
A few years ago, the two-bead technology had promise. The opioid epidemic was becoming better understood. As it's been litigated, it became clear, the two bead technology, as good as it may be, does not deter overdosing. This is true in the oral form, and in the FDA's mind it's true from a lack of BE due to inadequate Tmax.
Please read your own link.
https://www.reddit.com/r/weedstocks/comments/1xydch/market_maker_speaks_out_ways_of_a_market_maker/