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So Hikma does or doesn’t have 180 day exclusivity from 8/24/23 then?
Easily proved accusation when one has the proof on multiple other platforms as the person uses the same name throughout. 🧠
Way beneath the moral code of someone such as James, I suspect.
Definitely the best. IMO, James would never stalk and spam someone for over a year on multiple different platforms with literally zero to gain from it. That would be highly psychotic and disturbing. Be more like James.
Elite actually does make Loxapine and Trimipramine that could help those very troubled individuals.
Doesn’t act like a scumbag stalker basement dweller either. Positives for James all around!
I concur, James sounds like an actual human with a valuable perspective from the pharmacy side and not a boiler room rat.
What clown would supposedly hold this viewpoint of a company and then either buy new shares or continue holding shares previously purchased. Lol.
(No one)
Pivoting from the ADT strategy as basically a singular focus, while painful for shareholders at the time, turned out to be a brilliant move. We’re in a much better spot now fundamentally than we ever were before.
And the future looks brighter than ever.
Definitely a much bigger deal for Oxy although I do think having Kirko will make every single drug of ours more valuable.
I do hope you’re right and that they indicate the specific PDUFA dates for all 3 of the heavy hitters coming up!
Don’t think the PDUFA date is listed in the press release. At least it hasn’t been for the last 2 they told us about - the antimetabolite or the dopamine agonist.
I’m looking forward to the fiscal being reset to normal calendar year. March-March is weird.
Any idea how that transition works? Do we then have a year of only 3 quarters?
Funny little coinkydink I’m sure
Consultants/temps can be brought in to handle the finances until a permanent hire is picked.
Kirko more than makes up for a couple poor CFOs, IMO.
Seeking Alpha commenting on our news, just a rehash of Elite’s PR:
https://stocks.apple.com/AVGfeA8mEQRunXzt1zfX8QA
It is a worthwhile point of view / source of information, IMO. Thanks for your contributions!
So filed in Oct-Nov, approved maybe Oct-Nov 2024 you think?
Is Vyvanse the largest in the CNS stimulant category, do you know?
Well 1% market share is 51 million dollars in revenue. Lol.
If they match the percentage of the market they have with Adderrall IR (at least for April that they told us about), that’s $340,680,000 in revenues.
1 of 3 needle movers.
Yeah it’s in the CNS stimulant category.
Which drug has a market of 5.1 BILLION ??
Elite Pharmaceuticals Reports Positive Results from a Pivotal Bioequivalence Study
NORTHVALE, NJ / ACCESSWIRE / August 28, 2023 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company")(OTCQB:ELTP), a specialty pharmaceutical company engaged in the development, manufacture, and distribution of niche generic products, today reported positive results from pivotal fed and fasted bioequivalence studies for an undisclosed generic drug product in a class of medications called CNS stimulants. IQVIA reported annual sales for the twelve months ending June 2023 of $5.1 billion for the brand and generic market for this product.
The studies were open-label, randomized, balanced, single oral dose, two-treatment, two-period, two sequence, two-way crossover comparative bioavailability studies in healthy, adult, human subjects under fed and fasting conditions. The results indicate that the generic product is bioequivalent to the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration. ...
Guess I was right, delayed results. Lol
Still has to cover so he/she/it has no choice.
I’m interested to see how much extra manufacturing space Nasrat is aiming for when it’s time to expand. Currently in a GMP building of 55,000 square feet.
Epic was acquired with nearly 215 employees and a GMP building of 110,000 square feet.
Congrats?
I take that as he will sell off just enough to get his initial investment out and let the rest ride.
I would assume so. He mentioned the 3 NMs in clinical stages but could there also be other large generics like those, maybe further back like formulation development or entering PKs? Sure.
If this plays out how we expect, there will be many big winners here.
Vegas trip still on the table?
Don’t think either of the other two needle movers could be any on that list except Vyvanse. Nasrat said they were in the opioid or stimulant categories.
I hope so. Much rather underestimate and be surprised to the upside.
“A few minutes ago, I got a call from Kirko the IMS or IQVIA data came out for the month of May, we just launched in April and we didn't have that much material to launch, because we were making everything for Lannett. And for the month of April, for the [Adderrall] IR, were on command with 6.68% of the market. I definitely expect that number to improve.”
IF this is an accurate annualized number, that means Elite pulls in around $22,378,000 on the Adderrall IRs alone.
Per the intro, Adderrall IR is a $335M market. Although we don’t know exact numbers because Elite doesn’t break down financials by each drug, we know the lion’s share of Elite’s revenues are from the Adderrall IR/ER products. Nasrat also expects the Adderrall ER revenues to increase by 1.5 - 2x next year, likely a combination of Prasco/Burel + Kirko’s efforts.
Now let’s think about the biggest upcoming products - Oxy, NM #2, and NM #3.
Theoretically:
Capturing the same amount of Oxycontin market share (6.68% of $517M) = +$34,535,600/yr.
Capturing the same amount of Concerta market share (6.68% of $1.15B) = +$76,820,000/yr.
Capturing the same amount of Vyvanse market share (6.68% of $2.53B) = +$169,004,000/yr.
^ This completely discounts any market share we will gain from the dopamine agonist and the antimetabolite products that are likely to be approved in late Oct 2023 and late Dec/Jan 2024, respectively.
Even if these above estimates are wildly high, think about this. If Elite gets just 25% of the above numbers + existing revenues, that puts us north of $100M in revenues per year. 2 of the 3 NM products *should* be approved by or before EOY 2024.
Accumulated experience and this guy to also assist with making sure FDA filings are done correctly:
WILLIAM SCOTT GRONER Quality & Regulatory Affairs Consultant
Scott Groner is Vice President of Quality & Regulatory Affairs at Elite. Scott brings more than 30 years of regulatory and quality experience in both the pharmaceutical brand and generic industry and includes extensive knowledge in regulations, quality systems, assessments, FDA submissions, compliance, and product applications for both oral solid dosages and sterile and non-sterile liquid products. In addition to six years of consulting in the pharmaceutical industry, Scott’s experience includes positions at Duramed, Pfizer, Schering-Plough and Warner Lambert. Scott received a Bachelor of Science in Chemistry from Western New England College.
This is a good point.
Did we assume this trial he referred to was a BE trial because he also stated we would file another needle mover (not Oxy) before EOY?
But, they have also announced PK results related to SequestOx when they typically don’t PR those types of studies at all.
So, me personally?
Either they withheld them for competitive reasons - want to keep competition in the dark for as long as possible (if only ~2 months, so be it) until filing. We do know this could be one of the largest generics Elite has ever filed for, maybe THE biggest?
OR
Could there have been a delay of some kind, maybe Nasrat didn’t get the results the next day like he thought he would? Could they still be announced next week or so? Who knows.
We should hear about the filing relatively soon in any case, assuming things went well.
Unless you think they were negative. I just highly doubt it.
They *usually* don’t announce PK trials and they clearly never formally PR’d the human insufflation study that we now know was positive. They withheld those results for competitive reasons.
YES I KNOW BE TRIALS ARE A DIFFERENT KIND OF CLINICAL TRIAL.
Point is, they clearly decide to announce some results and not others.
Either that (withheld them for competitive reasons) or maybe there was a delay of some kind and they still do plan to release them? No idea.
Could potentially get both these PRs in October:
Oxy filing acceptance news + FDA approval of a smaller drug filed last December, $12M market
https://elite.irpass.com/Elite-Pharmaceuticals-Files-ANDA-with-US-FDA-to-Market-Dopamine-Agonist-12-22-2022
Not half the interest rate but half the total dollar amount paid in interest because the loan balance is much less.
Because we have an idea but we don’t know for sure which generic is being trialed (and neither does the competition).
As much as I’d like to hear about it now, I can understand the decision not to announce because that also typically comes with IQVIA numbers, which gives us and the competition a pretty clear indication of which product it is.
As far as self serving decisions, there have been some. But there is also paying off loans to save what, 50%+ in interest costs? Does it really matter if Elite pays Nasrat or Wells Fargo if Elite is now paying half the amount of interest they otherwise would’ve?
Who do you think is more invested in Elite succeeding - a random bank or the largest Elite shareholder?
Doing a great job with the standard earnings filings and calls and not even announcing likely positive trial results that he could have announced this week…?
Yeah, what a P&D… /sarcasm
Who are these amateur clowns
News flash - I don’t memorize every post you make and clearly no one else does either as the question of exclusivity came up.