Elite delivered every promise they made, sometime bit later than anticipated due to fda working slow, nothing to do with new management
Do you remember everyting they delivered the last 3 year?
3 years ago elite pharma ELTP had zero products or revenue.
Last quarter revenue was $2.7 million from generic operation. That's a 30% increase over last quarter's and a 114% increase compared to the Same quarter last year.
They also harvested $5 million in license fees, which were earned from the ELI-200 licensing deals , $10 million more to come next few quarters
I guess you wonder how they come so far In that small period of time from beeing on the edge of bankrupty to beeing a self sufficient R&D company
Well,the real money and uplisting will come from their abuse resistant technology so to keep the company alive they commercialy launched
- Hydromorphone Hydrochloride 8mg Tablets
- Naltrexone Hydrochloride 50 mg Tablets
- Phentermine HCl 37.5 mg Tablets
- Phentermine HCI 15 mg and 30 mg Capsules
- Isradipine 2,5 mg and 5 mg capsules
- Phendimetrazine Tartrate 35 mg Tablets, USP
- Dantrolene sodium 25 mg , 50 mg and 100 mg tablets
- Hydroxyzine HCI 10 mg, 25 mg, 50 mg Tablets
- Loxapine 5 mg , 10 mg , 25mg and 50 mg capsules
- Loxapine and Dantrolene launch by the end of Q1 of 2016.
- 10 Additional Approved ANDA's
Launched their own branded product
- Lodrane D
And contract manufacturing
- Methadone Hydrochloride 10 mg Tablets
- FDA just approved epics Oxy IR, which ELTP is entitled to 15% of the profits there up for 10 years !!!!
Working with different Companies to devellop new products
One based in Hong Kong.
To fund the heart of the operation wich is launching their first ELI product wich will be immediate-release Oxycodone Hydrochloride 5mg, 10mg, 15 mg, 20 mg and 30mg capsules with sequestered Naltrexone Hydrochloride they secured a $40 million financing deal with Lincoln Park Capital Fund, LLC.
They upgraded the facility with a state of the ART 1000kg fluid bed dryer.
Capable of producing over a BILLION pills a year
They found a partner and Secured 15mil from that ELI200 partner before even one pill is sold.
15% profit share with epic regarding er oxy to hit the books too
ELITE is Months away from beeing the first player in the +20 Billion abuse resistant/deterent opioid market
Competition is stil years away
Phase 3 pivotal trial met its primary endpoint (p = 0.001), demonstrating statistical significance that the product provided pain relief following surgery in the treatment group using ELI-200 compared to the placebo group. Secondary endpoint results were consistent with primary findings and included safety measures.
So to list it up
We have
Successful formulation/technology: COMPLETE
Pivotal BE Study: COMPLETE
Registration batches: 6- mos ACC, 24- mos CRT: COMPLETE
Lab Abuse Study: COMPLETE
Elites ADF opiods can not be defeated by:
snorting
injecting
smoking
chewing
crushing
sucking
use with alcohol
splitting
breaking
grinding
sandpapering
blended
melting
microwaving
dissolving in solvents
cutting/splitting
baking(cooking)
lasering
charring
melting
visual bead separation
Liking Study, Intranasal: COMPLETE
Fed Study: Dosing COMPLETE
Withdrawal Study: Dosing COMPLETE
Efficacy Study: Dosing COMPLETE
Pediatric Study: Post product launch
Pre- NDA meeting: Positive Guidance Recieved
Elite's First Art NDA Filing- ELI 200: COMPLETE
FDA NDA Acceptance: Imminent
NDA Expedited Review: Imminent
ELI-200 Launch: Scheduled for 2016
Uplist to NASDAQ shortly after launch
Within few weeks FDA accepts filling for their first ART product, normaly this costs 2.3 million , elite get this first filling for free.
this non abuse deterent variation had over $3 billion in sales last year.
FDA acceptance will trigger the partner to send out an army of 100 salesman .
they usually first go after largest chains like Walgreen, Wal-Mart, CBS and the like and after that every pharmacy in every big city.
The also send out consultants to educate the market about ELI200.
They will be harvesting pre-orders all over the country.
These orders could pas the 100mil mark
Imagine what 100 mil first quarter in revenue can do for a company with market cap. shy over 200 mil .
There is also a big chance FDA will mandate the removal of non ADF opiods.
This will give Elites Immediate Release ADF oxycodone a 91% market share thus propelling PPS +$20 on just one product.
Since they have the first filling for free they could already filled second NDA as we speak.
Plenty more where that came from, they have a whole pipeline of 15 ART Product waiting to be filed with the FDA TO GARNER EVERY PENNY THEY CAN FROM THIS 20 BILLION DOLLAR MARKET
And from zero to all of that happend in just over 3 year
Cant wait to see what the next 3 year will bring.
One thing is for sure
ELTP IS NOT A TYPICAL OTC STOCK.
So to put all the above in a few lines, company with same fundamentals would trade around $5 on nasdaq
But Eltp got stuck in this otc swamp due to bad management, new management team made the turnaround, thats for sure, but pricewise still stuck,i'm 100% sure ELI200 Launch will also launch us up to nasdaq where the real money will come from
So buy all you can afford under a dollar , and you are months away from early retirement
P. S. i'm flemmisch, so sorry for the gramatical errors
