[b]I hate to advocate drugs, alcohol, violence, or insanity to anyone, but they've always worked for me.[/b]
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That FDA inspection of the facility the week before the conference call was a preapproval inspection in my opinion.
An approval(s) is(are) coming. Could be the site transfers back from Epic to Elite.
And again........
Investors BEWARE
TOXIC PREFERRED AND WTS
ceo issued to himself with RATCHET ...
Did I mention the fact that in the original 163 person BE study there was not one incident. Nothing. Subjects were told to eat anything they like.
No mishaps. Look the results up yourself.
So why after this 163 person BE study with no problems whatsoever did the FDA balk at giving Elite a labeling claim? Take 1 hour before a heavy meal or two hours after a heavy meal. Simple solution.
But as you point out, that is all in the rear view mirror.
And how do I know that this reformulation for their IR ADF SequestOx will
carry pretty much the same results if Elite is asked to go forward with a new BE test? And why may Elite go through with a submission of this pilot
study to the FDA in hopes of expediting the process without going through another larger expensive BE study?
One thought comes to me, and it is a very simple solution to the capsule versus the tablet release. A J&J subsidiary comes to mind. So simple and many companies are doing it.
Yeah.... I'd be nervous if I was betting against Elite. Very nervous.
Submitting the kind of data they submitted and then try to get it fixed by labelling it is just plain lazy
Thanks for pointing that out pharma sleuth.
The ADF is the future of prescription opioids.
Glad you get a laugh out of the 20 pathways to dollar land. It's coming.
And just wait until Elite gets their better Embeda, which will not leak due to additional Naltrexone.... AND the rush from snorting will be reduced by up to seven fold with Elite's single bead version.
Current Embeda can probably be compared to APAPs which are readily abused.
FDA may have to rethink the APAP situation. Lots of abusers abusing Percocet and Norco. Acetaminophen doesn't do much to deter abuse, just as the minimal amount of naltrexone will not do much to deter abuse of morphine in current Embeda.
Eventually FDA will have to move on both Embeda and APAPs IMO. Elite has the ADF for both.
Already did the studies needed for the APAPs. So if the FDA ever decides to go Percocet with Naltrexone Elite will be there locked and loaded.
As for Embeda.... Elite's version is superior to the current version. Just my opinion now. Others may feel the original Embeda is good the way it is.
Less naltrexone..... more abused.
Prior to their little pilot study there was no hope at all
It's coming.
You are right, all those successful approved two bead drugs prove it... oh wait... :)
What are the sales figures for Embeda?
Are healthcare professionals confident enough to use it?
If so then sales must be pretty good.
I'll wait while you dig those figures up.
Chasing...... they do not approach Elite yet. They may have to in the future if laws are changed where companies have to license a technology IF they do not already have one of their own to use.
These companies will either have to license or lose market share when the FDA requires all prescription opioids have an ADF attached.
And this will benefit Elite when a buyout comes. Who gets Elite's ADF will get possible licensing of the ADF to other companies. Very lucrative indeed.
10 years ago this ADF technology that Elite had was only a pipe dream.
NOW that they have several patents both US and international Elite's technology is NOT a pipedream.
By the way, just to make something clear, the FDA has no problems with Elite's technology. In fact the FDA likes it. The only matter in question for the FDA was for Elite's IR formulation of opioids, that being time to maximum concentration in the blood stream after a high fat meal.
Guess what? Seems like Elite may have solved that problem after disclosing results on the pilot testing.
NEXT!
Agree that part of this has been that ADFs are a new technology that the FDA is just beginning to wrap their head around. Needless to say, if one thinks there are no means by which Big Pharma and wealthy consordiums who own or operate those companies are not trying to delay the ADF march, then one is naïve to think otherwise. Too much money at stake here.
From the Esquire article:
The American market for OxyContin is dwindling. According to Purdue, prescriptions fell 33 percent between 2012 and 2016. But while the company’s primary product may be in eclipse in the United States, international markets for pain medications are expanding. According to an investigation last year in the Los Angeles Times, Mundipharma, the Sackler-owned company charged with developing new markets, is employing a suite of familiar tactics in countries like Mexico, Brazil, and China to stoke concern for as-yet-unheralded “silent epidemics” of untreated pain. In Colombia, according to the L.A. Times, the company went so far as to circulate a press release suggesting that 47 percent of the population suffered from chronic pain.
Napp is the family’s drug company in the UK. Mundipharma is their company charged with developing new markets.
In May, a dozen lawmakers in Congress, inspired by the L.A. Times investigation, sent a bipartisan letter to the World Health Organization warning that Sackler-owned companies were preparing to flood foreign countries with legal narcotics. “Purdue began the opioid crisis that has devastated American communities,” the letter reads. “Today, Mundipharma is using many of the same deceptive and reckless practices to sell OxyContin abroad.” Significantly, the letter calls out the Sackler family by name, leaving no room for the public to wonder about the identities of the people who stood behind Mundipharma.
---------------------------------------------------------------
So, do you think Mundipharma is targeting countries likely to get an ADF technology soon? Highly doubtful they are.
And what does such a move remind us of? Big Tobacco. When they started losing the American market companies like Philip Morris went overseas
to peddle cancer causing tobacco. Straight fact.
Sacklers are doing likewise. Purdue being their American arm.
Rocioyogi, even if Ama's dream comes true with the site transfers complete
it would mean more revenue for the future of Elite. A welcome sight.
About time something went Elite's way. The FDA inspection two weeks ago
should have keyed people to an approval. Something to watch for in the future whenever an approval is imminent.
$10 million is a drop in a 5 gallon bucket. Peanuts from the drug companies, so that they can continue to make BILLIONS on this.
Makes one wonder who is worse..... Pablo Escobar, Joaquín Guzmán
Mexican drug lord, or Big Pharma that resides right here in the good old U S of A. I'd say the drug lords should take lessons from Big Pharma. Big Pharma has learned how to peddle drugs legally, make billions, and suffer no illegalities while a part of this crisis.
Just throw the people a few shackles every now and then, and continue your hawk your goods with a smile.
NASDAQ LMAO! I averaged UP too. Anything below $0.50 is like highway robbery. Elite is a definite buy and hold.
The Esquire article has shown another problem that couples with what you mentioned N2K, the powerful groups that are keeping ADFs off the market.
The Sacklers are just one group of such people.
Without ADFs on the market these powerful groups continue to rake in major dough. Maybe there is also the political aspect of major campaign contributions from Big Pharms much like the NRA and the gun lobby.
The similarities to other industries such as big tobacco and the NRA are very striking and very real.
McKesson, Purdue, J&J, and others stand to lose big markets to ADF alternatives which in turn would cost those companies major money and time to develop on their own. Meanwhile a little company like Elite sits here with a key ADF technology.
N2K, you have been saying this for a long time, a buyout will come, and I have no doubt that it will. It almost has to. There may be a several suitors for Elite in the near future. Would not be surprised if Elite is in a bidding war between other Big Pharmas when a buyout comes. Who controls the ADF aspect of this sector will have control over market share. Just my opinion.
Thoughts from a real doctor? What could it have been Elite tested? LMMFAO!
Ama come down off the bridge. Don't jump. Don't do it.
So powerful is this group that there may be some who post on their behalf right here on this forum..... continuing to make billions on this opioid crisis. Greed rules....... lives don't matter.
Gives one pause to wonder, doesn't it.
Among those pharmaceuticals named in many lawsuits right now is the one and only Purdue Pharmaceutical. The Sackler family must be mighty proud
of their fortunes, yet they distance themselves from any relationship with Purdue Pharma. Disgusting......
https://www.esquire.com/news-politics/a12775932/sackler-family-oxycontin/
Many town hall meetings throughout the nation recently. My area is Pennsylvania. People are downright frustrated.
http://abc27.com/category/news/local/opioid-epidemic/
http://www.standard-journal.com/news/local/article_4b59a4de-10b5-11e8-bd9b-0f99a80dfdb8.html
Planned town hall meetings:
https://patch.com/pennsylvania/northhills/opioid-epidemic-be-topic-town-hall-meeting
Many suggestions to this crisis:
http://6abc.com/health/opioid-crisis-are-safe-injection-sites-the-answer/2978312/
Ground zero for Philly:
http://6abc.com/health/emerald-city-ground-zero-of-phillys-opioid-crisis/2978752/
Law suits pile up on pharmaceuticals:
http://6abc.com/politics/philly-sues-opioid-makers-in-response-to-epidemic/2958867/
http://6abc.com/news/ohio-attorney-general-sues-5-drugmakers-over-opioid-epidemic/2059442/
Devon Alexander fight last night was more than a boxing match. Alexander's comeback from opioid addiction is a real story. He should have won that fight, instead judges gave the fight a draw. Ortiz got lucky.
https://sports.yahoo.com/former-world-champ-devon-alexander-kod-opioid-addiction-191501344.html
And if he doesn't launch those three because ONE will make more than those three combined?
The apple doesn't fall far from the tree. LOL
Try something a little more substantial as far as revenue generating......
Would not surprise me.
NH did mention the FDA being at the facility the week before during the conference call for anyone listening and willing to pay attention. No observations. More than likely a pre-approval inspection
which is the FDA standard operating procedure before an approval.
Just my opinion NASDAQ, but I think this sort of action by the FDA will require them to have something to take the place of non ADF opioids.
It puts a great deal of pressure on both the FDA and the DEA to start coming up with solutions. Elite's ADF technology is one such solution.
The sooner the ADF trend starts the sooner the DEA can begin to concentrate efforts on illegal narcotics like heroin. The sooner states and the federal government can begin to spend much less money on treatment
of prescription opioid abusers.
What will happen when FDA pulls non-ADFs from the market?
My point about Epic oxycodone was that is was one of the last approvals given to any company for that opioid without an ADF attached.
ADFs and non abuse formulations are coming. Not a matter of if, a matter of when. The FDA and DEA are being pressed into doing something sooner than later.
Of course, big pharma doesn't want to lose money selling non ADF forms so the dance continues until the music stops. When the music stops is anyone's guess. One would think it has to be soon though.
Some interesting reading as to who is responsible for the current opioid epidemic. When one has the type of money the Sackler family has many things can be twisted to their advantage. After all, it is all about the money.
From the October issue of Esquire Magazine:
https://www.esquire.com/news-politics/a12775932/sackler-family-oxycontin/
Post some links for that please.
nformed investors understand ADFs are a red herring, as was declared numerous times by experts in the field
In fact, there are studies indicating wide adoption of ADFs will lead to a greater number of deaths in abusers being forced to transition to harder drugs, like heroin
IR or ER doesn't matter, has nothing to do with anything I posted.
Basic stuff. Oxycodone is the IR form without any resistive or abuse deterrent properties. It is what Epic manufactures, sells, and what Elite gets 15% of Epic's profit on.
OxyContin, on the other hand is now in a resistant form. The one with the hard tamper proof coating which doesn't really do anything to prevent abuse except maybe in a healthcare setting where people do not have access to microwave ovens, coke a cola and lemon or lime juice.
The name is different because OxyContin is SUPPOSED to be extended release. Supposed to be is different from what it really is. It does not give extended 12 hour relief from pain as its manufacturer claims.
So maybe OxyContin is a tweener release medication.
In case you want further proof, because Purdue was involved, here is the link:
http://www.latimes.com/projects/oxycontin-part1/
Oh... and here is another link just in case the first one doesn't satisfy.....
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5019471/
========================================================================
I hate to advocate drugs, alcohol, violence, or insanity to anyone, but they've always worked for me.
Hmmmm. Very interesting.
That is Epic's oxycodone. OxyContin is the hard turtle shell abuse resistant formulation.
Epic squeaked just under the bar to manufacture oxycodone without any resistant or deterrent form involved. Yes, Elite does get 15% of profits from Epic's sales.
Let the games begin.
FDA inspection last week possible pre-approval inspection.
It's coming!
Last I checked the FDA did a 180. It's all good though, unless the FDA
has more surprises. Will have to see what exactly what the FDA wants with regard to testing.
Speaking of the FDA...... the were at Elite last week. Did a full facility inspection, mostly cGMP, wonder what that was about? LMMFAO!
Better grab em while you can if you want more. Just my opinion.
Stock mom, thanks for posting the transcript of the CC. Read it while at work.
Stellar conference call.
Oh... there may be a GOOD reason for that FDA inspection very recently.
So push that share price down, will ya?
TIA
Depends on how you are looking at this..... I do not recall any PROMISES.
If there were promises made share holders would be in the law suit line.
Hate to break it to ya Jour, but this is an INVESTMENT. NH NEVER MADE any PROMISES.
Oh, and with a renewed BE now that they have a rock solid pilot study, we will see who can stop us. Not a promise. A fact.
Looks like Purdue is dropping one shoe........
Cannot wait for the other shoe to fall.
Oh yeah..... isn't one of the Elite ANDAs generic OxyContin? By golly it is!
Like the Eminem song "One Shot" Purdue had theirs.
Could have held Elite's ADF but rejected it because they thought theirs was better. Never made it off the drawing board. Elite's did.
End of story.
Purdue..... so sad.
Purdue knows.. handwriting is on the wall. Time to find a new gig.
Dear Leader Nasrat