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Triggered. LOL
Doubt it but I wish he would if for no other reason than I’m growing tired of waiting on Elite to bloom. Lol
Hilarious. Guarantee if it was a “death cross”, it would be harped on over and over and over again.
So this would make sense / help to explain why they asked for this data on one ANDA and not the other based on when they were filed.
Like Elite.
Wrong, many pharmas are bought out without making a dime.
Thanks for the opinion on ELTP
It does make one wonder why they’d go through all the trials, application, adcom and approval to just sit on it and not launch. Been over 1.5 years now?
https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_troxyca_er_oxycodone_hydrochloride_and_naltrexone_hydrochloride_extended_release_capsules_cii_with_abuse_deterrent_properties_for_the_management_of_pain
The run lasted like 2+ weeks and the price stayed quite elevated for months above the levels it had been trending at. The argument is they couldn’t find 2 business days in that timeframe to sell and file Form 4s?
Lmao. Sounds legit. /s
Good DD, Triple R. Refreshing break from the swamp of BS.
Prove it.
What truth would that be?
Already cycled back around to this again so soon?? LOL
If they wanted to sell, wouldn’t they have done so?
They have to file every time they buy or sell.
They didn’t sell because they didn’t want to yet. Period.
Interesting BS read at least. Holler when links are found to back these claims. We’ll be here.
He isn’t the one making the claim... lol. Burden of proof on the accuser.
That’s mostly a fair assessment.
Absolutely agree on green lighting the tech. When it happens, that purchase price rockets upward violently.
I’d be interested to see what the FDA thinks about our once daily ADT opioid from years back. Should only need Phase 3 and HAL trials left before submission. Both big pharma and patients should be all over that.
Yeah I heard .02 and bankruptcy was coming for years too. Failed predictions.
Sure, just show proof
So the date makes it inaccurate? Lmao.
The rebuttal is “it’s old.” Hahahahahahahahahahahaha.
HAS* good potential. Still not understanding the “problem” presented by some people here. Some act like the ship has sailed. There is a higher focus on ADFs now than possibly any other time.
Could Elite have commercialized sooner with competent management (mostly pre-Nasrat but he also receives some blame)? Of course, I don’t think anyone would dispute that.
That being said, this company, stock, and abuse deterrent technology is far from dead. Quite the opposite.
Well it’s been a smashing commercial success so surely he’s wrong. /sarcasm.
LOL
He didn’t tho. Lolol
Oh, you mean like this generic ADF industry guidance from November 21st, 2017 by the FDA? Lmao.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586117.htm
“Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence.”
“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.”
NEXT. LOL.
Best of luck Mazeppa.
Didn’t understand you here though:
“seems we are going with an entirely new formulation, not the 2-bead, so again more unknown, more risk.”
Yes, that is another IR formulation they trialed in the pilot study in addition to SOX, but SOX is still the same 2-bead tech it’s always been.
He didn’t say that wasn’t the case... lol
So in that case, is it really fair to say Elite is behind the 8 ball on a generic Embeda, given the earliest it could’ve even been approved was October of 2017, about 4ish months ago?
When did Embeda come off exclusivity, or has it?
“jesus. all the rest of the pipeline aside, modifying the excipient is going to make almost all the work supporting the original NDA no good. we will probaably be able to pass the nda eventually, but no way FDA accepts the abuse studies etc and the p3 bioequivalence is gonna have to be bigger than if we didn't have to modify”
What do you make of this? Think the FDA allows us to bridge new SOX 2.0 trials/data with the original submission data from SOX 1.0? Hopefully with just another pivotal BE trial required and then we can resubmit?
Think it’s been worked on for 13 years or something? Good luck!
If it was ELTP incompetence, why did the FDA request the impurity information on one ANDA and not the other if they are very similar? Doesn’t make sense.
Aye. A seismic shift to some type of non-opioid medication will take quite a long time. These drugs first have to be developed and approved, practicing docs would need to be convinced to prescribe them over opioids and ADT, med schools will have to change teaching criteria, etc etc.
Bingo. Inconsistent, bureaucratic red tape agency, pretty typical of government institutions.
Lol nope. There are only a few ADT drugs currently approved and marketed. They will still be around and growing for many years to come and Elite’s line of products will join those ranks.