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TIL $500,000,000 is puny. Wonder what I’ll learn tomorrow.
I spoke to them as well and they didn’t say that at all. Interesting.
Takes time to get the lots ready for sale. I imagine we’ll see some announcement of Glenmark taking on this product sometime in the next month or two.
I’d say making a $1,000,000 personal loan to your cash-strapped company and being able to take salary in shares for several years makes one fairly wealthy.
Pulled back? Wrong.
They are filing (and soon launching) ANDAs in the downtime of communicating back and forth with the FDA on SequestOx.
Anything is possible but I think it would be highly unlikely. Elite will probably need to perform another BE trial with the newest formulation(s) prior to resubmission.
There is no “ratchet” per the CFO.
A reverse split would hit the CEO harder than anyone else. IF one is done at all, it will be done from a point of strength.
I do not. I’d guess 2-3 months from now. Would be nice if earlier.
What did you say recently about Percocet orders... are you able to see what manufacturers have the most market share and such?
Agreed.
I think AMA was asking why specifically for this one because the majority of the other new filings with much larger markets are not undisclosed. My guess is it had something to do with us already contract manufacturing Methadone when we filed the undisclosed ANDA. If it is indeed Methadone, maybe that would’ve rubbed TPN (or whoever our partner was) the wrong way?
Worked out exceedingly well for JAZZ.
Maybe because we contract manufactured Methadone for someone else and he didn’t want to tip that other party off upon filing the undisclosed (Methadone?) ANDA that we would eventually cease business with them and start making our own?
Just a guess, don’t know for sure.
What company with Chinese roots would that be?
Sounds more like “trust but verify” to me. Pretty simple really. Not sure why anyone wouldn’t want proof of an event occurring, regardless of who said it would occur.
But which ones make up the lions share of the market? In my experience, 5, 7.5, or 10 were almost always written for. Very rarely saw any other dosages.
Nope, not for Elite’s dosages which are the most common ones.
Why are you including dosages that Elite is not and cannot compete for? They will be making 325/5, 325/7.5, and 325/10. They will never even be considered for a 325/2.5, a 300/2.5, a 300/5, or a 300/10.
You can say that the total market number goes down if you exclude those other dosages, yes.
I have.
72 entries excluding discontinued ones. Some are for dosages Elite isn’t approved for and are odd dosages to begin with.
Indeed, it isn’t. Looked at the list from the FDA myself many times.
There. Are. Not. 30. Manufacturers. Within. The. 3. Dosage. Forms. Elite. Is. Approved. For.
Discontinued. Ones. Do. Not. Count.
Elite is not competing against 30 other manufacturers for the 3 dosage forms they are approved for, period. There could be 30 total manufacturers for Percocet as a whole, but it doesn’t make sense to include those who make the “odd” dosages like 300/2.5, which are likely the oddballs and not prescribed nearly as much. Elite isn’t competing for that - the doc either prescribes that amount or a 325/5, 7.5, or 10 and then it gets filled by Elite or one of the other 17-18ish manufacturers that make those dosages. This isn’t complicated.
Except there isn’t 30 in each of the dosage amounts Elite is approved for and I’ll continue to slap that BS down every time I see it.
Well clearly Percocet was just approved so I’d say that’s a good sign.
News flash: DISCN is checked - as in DISCONTINUED. LOL. I’m sure that’ll be tough for Elite compete with indeed!!! LOL!!!!!!!!
~17-18 manufacturers like I said!!!!!!! NOT COUNTING THE DISCONTINUED ONES LOLOL
Not for the dosages Elite is approved for. Lolol. That is an undeniable fact.
ABOUT 17-18ISH MANUFACTURERS PER DOSAGE FORM THAT ELITE IS APPROVED FOR (325/5, /7.5, /10), INCLUDING ELITE AND EPIC. LOL. PERIOD.
No John, a random spreadsheet doesn’t supersede the FDA Orange Book. Lol. Gotta weed out discontinued ones. 17-18 manufacturers for each of the 3 dosage forms including Elite and Epic.
Commonly prescribed after surgery. Possibly a synergistic effect from the Oxycodone/Acetaminophen combo and it’s a solid pain med without giving you higher doses of straight Oxycodone.
Huh? Check again!!
I dunno if it’ll be that much but should at the very least double or triple current revenues.
Nope. Prove it.
They aren’t the 31st entrant though lolol. Repeating that false claim a thousand times, million times, etc. doesn’t make it true.
That is the full list. Searched active ingredient and brand name. 17-18 including Elite and depending on dosage form.
Wrong. Not what niche means either. Batting .1000 today. LOL
Wrong, Nasrat never said that.
Wrong again, almost half that number depending on dosage form. LOL. Anyone can pull up the FDA’s Orange Book and verify for themselves too. Search “oxycodone and acetaminophen”.
Including Elite on each, looks like 18 pharmas for 325/5, 17 for 325/7.5 and 18 for 325/10.
Agree with this.
They partnered with Glenmark on Phendimetrazine and the undisclosed ANDA expected to be approved in 3rd quarter (Methadone?). 30-40M market.
Unless Nasrat has his sights set on a larger company, I don’t see why they wouldn’t add Percocet, with its 500M market, to the Glenmark agreement.
Today I learned that a $500,000,000 market is “puny” and “niche.” LOL. No telling what I’ll learn tomorrow..
Only 1 drug manufacturer allowed per drug in China, JJ. Cmon, you know this. Lol. /s
https://www.sec.gov/Archives/edgar/data/1053369/000114420414040327/v381997_10k.htm
“We also recently acquired approved Abbreviated New Drug Applications (“ANDAs”) for 12 products (the “Mikah Approved ANDAs”) and one ANDA that is under active review with the FDA (the “Mikah ANDA Application Product”) that were acquired pursuant to the asset purchase agreement with Mikah Pharma dated August 1, 2013 (the “Mikah Asset Purchase Agreement”). On October 2, 2013, we executed a Manufacturing and License Agreement (the “Epic Agreement”) with Epic Pharma LLC. (“Epic”), to manufacture, market and sell in the United States and Puerto Rico 12 generic products owned by Elite. Of the 12 products, Epic will have the exclusive right to market six products as listed in Schedule A of the Epic Agreement, and a non-exclusive right to market six products as listed in Schedule D of the Epic Agreement. Epic is responsible for all regulatory and pharmacovigilance matters related to the products and for all costs related to the site transfer for all products. Pursuant to the Epic Agreement, Elite will receive a license fee and milestone payments. The license fee will be computed as a percentage of the gross profit, as defined in the Epic Agreement, earned by Epic as a result of sales of the products. The manufacturing cost used for the calculation of the license fee is a predetermined amount per unit plus the cost of the drug substance (API) and the sales cost for the calculation is predetermined based on net sales. If Elite manufactures any product for sale by Epic, then Epic shall pay that same predetermined manufacturing cost per unit plus the cost of the API. The license fee is payable monthly for the term of the Epic Agreement. Epic shall pay to Elite certain milestone payments as defined by the Epic Agreement. We received the first milestone payment in November 2013. Subsequent milestone payments are due upon the filing of each product’s supplement with the FDA and the FDA approval of site transfer for each product as specifically itemized in the Epic Agreement. The term of the Epic Agreement is five years and may be extended for an additional five years upon mutual agreement of the parties.”
So October 2nd or 3rd, we get our remaining generics back from limbo with Epic. 3 months away. Probably just enough time to launch Percocet and then gear up to start launching the Mikah drugs and/or any other large generic ANDA approval between now and then.
YUP. We’re in for a slew of approvals and a slew of launches. Today marks a turning point for Elite. Cheers.
Thought I heard they wouldn’t ever get approvals in the first place tho.. lolol whoopsie
Bingo. Happy 4th to you as well.
I believe this marks a significant turning point for Elite. Now that we are confident in Nasrat’s ability to get an ANDA approved from start to finish, the rest is just timing. Very excited. We’ll see a slew of approvals and launches ahead.