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( 1) Jeenarine Narine is gifting 2,000,000 warrants to his son.
http://investing.money.msn.com/investments/sec-filings?symbol=ELTP
He is very much a lawyer as conferred by his Juris Doctorate degree.
If he was admitted to a bar and practicing law he would be referred to as an attorney.
http://en.wikipedia.org/wiki/Juris_Doctor
While individuals holding a J.D. are generally known as lawyers, those professionals who pass a required bar examination are generally known as attorneys.[16] Even though not all J.D. holders choose to take and pass a bar exam, those who elect not to take the exam or are otherwise not admitted to the bar are still known as lawyers based on the education they have received and the degree that has been conferred upon them.
OK, you were the one that said:
"First, Nasrat must have successful trial results to report !!"
I'm just making sure any new investors don't get confused.
But Nasrat does have successful trial results to report!
See:
http://www.elitepharma.com/investor_relations.asp?goto=377
and
http://www.elitepharma.com/investor_relations.asp?goto=378
One year as CEO and the PPS is up five fold.
I'm feeling pretty maximized myself.
So what? It can't help OIC and be abuse deterrent?
The FDA is misleading now?
Perhaps this might be a good read:
http://download.springer.com/static/pdf/55/art%253A10.1007%252Fs40122-014-0026-2.pdf?auth66=1406476633_c6b33058cabcde318e308e75f8801717&ext=.pdf
As prescription drug misuse with oxycodone and
other opioids has grown to epidemic
proportions in the US, the presence of
naloxone as an abuse-deterrent feature may
potentially confer additional benefit,
particularly for oxycodone abusers who prefer
non-oral routes of ingestion. It is unclear how
the presence of naloxone will affect abusers who
prefer to ingest large quantities of the drug
orally. More research on the impact of abuse
deterrence for this formulation is needed.
http://www.latimes.com/science/sciencenow/la-sci-sn-fda-oxycodone-no-abuse-20140723-story.html
Lynn Webster, a pain and addiction specialist and former president of the American Academy of Pain Medicine, agreed that abuse-deterrent drugs were no substitute for judicious prescribing.
But, he said, “the obvious alternative is not to have abuse-deterrent formulations, and I don’t know anyone who would find that preferable.”
http://www.suboxone.com/content/pdfs/SuboxonePI.pdf
SUBOXONE sublingual film is a partial-opioid agonist indicated for treatment of opioid dependence. Prescription use of this product is limited under the Drug Addiction Treatment Act. (1)
In the FDA press release!
Yes.
Targiniq® was originally created by Mundipharma to address OIC.
However, Targiniq® ER is different. The naloxone is only released when crushed, not co-released. If the naloxone was also ER when crushed then it would be longer acting no?
Look, the FDA has practically endorsed this in a press release.
They specifically said:
abuse liability studies demonstrated the abuse deterrent features of Targiniq ER as they relate to certain types of abuse (snorting, injecting)
I only want to make sure we know what we are talking about here.
Perhaps Elite's formulation will prove more effective.
Also, interesting article/video here.
http://time.com/3031100/fda-pain-bill-targiniq-er/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed:%20time/topstories%20(TIME:%20Top%20Stories)
What if the Naloxone is released gradually?
Link for ya:
http://www.sec.gov/Archives/edgar/data/1053369/000114420414040327/v381997_10k.htm
Right on page 2.
It's a good idea to read the filings.
Info from Diane on the recent 424 filing/Notice of Effectiveness:
The red herring language was removed from the S-3 and the prospectus was dated as of the effective date.
There were no substantive changes.
http://en.wikipedia.org/wiki/Red_herring_prospectus
Forgive me if this has already been posted...
But I stumbled on this:
http://www.peregrineinc.com/images/stories/pdfs/fact_sheet_june_2014.pdf
Seems like a nice summary.
Yes.
May bode well for ELTP getting priority review as well.
Sorry conix, didn't mean to be a jerk.
I actually thought "prodrugs" was a typo for "products"!
You'd think they would capitalize it as "Prodrugs"
Anywho....
Always appreciate new info.
"our prodrugs"??
I'm supposed to take this seriously?
I'm at a winery in the sunshine enjoying a great band. Go out and have fun. ELTP will take care of itself.
Elite gets recognition from highly regarded Evaluate Pharma:
$250m pharma companies: top risers in H1
http://www.evaluategroup.com/Universal/View.aspx?type=Entity&entityType=Company&lType=coInfo&id=2801&componentID=co#&&_ViewArgs=%7b%22_EntityType%22%3a0%2c%22_Parameters%22%3a%7b%22_ContextData%22%3a%22%7b%5c%22isEPVantage%5c%22%3atrue%2c%5c%22percentage%5c%22%3a-1%2c%5c%22searchWords%5c%22%3a%5c%22%5c%22%2c%5c%22sectionID%5c%22%3a%5c%22%5c%22%2c%5c%22storyID%5c%22%3a%5c%22517052%5c%22%2c%5c%22notSub%5c%22%3afalse%7d
the lack of real progress in revenue?
Ummm they just reported a 35% increase in revenue YOY.
Progress on the pipeline? LOTS of that.
9 products 1/1/2012
31 products in the pipeline today.
How many clinical trials have they initiated?
Well said. Thank you sir.
Most of us would be well served to let their shares ride and relax and enjoy the summer. Come December things should be percolating nicely.
Thor, agreed.
Not too any catalysts now til maybe August call which is just 6 weeks away.
Isradipine delayed to late summer/early fall...no partnerships expected til end of year at best, the default won't be removed for months, Rodman not til Sept...liability trial results not til Fall...
The only thing that "might" happen is the start of more trials for more ART products. Patent on the microtablets perhaps?
The Q1 2015 numbers will be much better I think....look at the inventory levels in the 10k....
What is NOT to love from that conference call?
...Our March 31 balance sheet is by far the strongest one that I have reported in my five years as Elite's CFO and it's likely the strongest balance sheet in Elite's history.
...we expect to finally remove this cloud of default which has hung over our head for more than five years.
...We're on track to file by year's end, again barring no more FDA requirements. The FDA has been very positive in the comments they've sent us but definitely at the end of the day when they see the totality of everything they will make the final decision.
...I continue to talk to several potential partners and licenses. There is tremendously high interest out there in our company and in our products. As I have discussed before we will wait for the right time and for the right partner. The further Elite takes this product on her own the higher the value to the stockholders will be.
...Isradipine: we are hoping to launch later this summer or early fall
...Hydroxyzine, has already been manufactured and placed on stability. Dantrolene, they are also working on that; on Loxapine they are in negotiations with an API supplier.
...The Lincoln Park equity line of credit has been excellent for us. The first one set the stage for us to raise enough money to do all the clinical we're talking about right now. And the second one we have not tapped too much into for two simple reasons really. One because the stock price is not that high, we think it could be better. And two or more importantly it is because we have enough cash at this time that we don't need to dilute the shareholders any longer.
...So I would say for the money we have right now for the product you're selecting we probably can get five easy.
...Well that's exactly it, we had milestone payments related to the transaction we did with Epic, which was in the prior quarter, in the quarter ended December. That was $600,000 milestone. So that's really the -- that's the milestone so it didn't repeat itself during this quarter. That would be the biggest thing.
...So let me give you a simple example here on how I think. Let us assume this 100 million shares that we divest or dilute everybody with are for let say a 1,995 million so the total dilution let's say would be 10%.When you take 10% of your value and switch it into equity that's going to compete in a market of $10 billion. To me the return on investment is huge, it's a foregone conclusion that we have to do it.
...Unidentified Analyst
I am trying to find out if there is any planned future [inaudible] for any investor awareness campaigns keeping the stock at its fair price [inaudible].
Nasrat Hakim - President and CEO
Yes there is. We have not focused on that yet because we have been busy trying to get our technology to clinical trials and all of that. Now that we're going all the positive results that we've been, it is time for us to hit the road. We will Rodman and we will see where we go from there. I get calls from T.V shows all the time that they want to feature us on this and that. And honestly even though it will be good for us but it is it a little bit of distraction. Once I have a solid product to file then we will hit the road and start the campaign to start to get everybody's attention to the great products we have.
...First I am not going to have a stock split because the fundamentals does not support it right now. We will either organically grow back on to a NASDAQ or a major stock exchange or when we have fundamentals we’ll revisit whether we're going to have some kind of a stock reverse split. At this time I have no intention of looking at any of that. My focus is to get the products through the FDA, build some equity into this company and then evaluate the value of the company at that point.
...Unidentified Analyst
Thank you for that. Do you feel and just maybe a gut feeling that there is some type of adverse manipulation on the stock price right now that's kind of trying to hold us in this pattern for whatever reasons?
...but I do believe that by this year's end we'll make a decision with the potential people we're talking to on what kind of a partnership or arrangement we will have with them. Anytime you go into the market with a partner these partners are going to demand something. They may pay for some of the clinical trials with someone upfront and they would want let's say 50% of the revenue later.
When you are talking about $1 billion product, that's a high price to pay, it’s a very high price to pay. So we have currently two very good options. And everybody of course wants the lion’s share if they want to join you before you have approval or a clear path from FDA that everything is going to be great. And we're now willing to pay that price.
I am much more comfortable spending the money we've raised from our revenues, from the arrangements we have with Novel, from Lincoln Park because it has a lot lesser impact on the stockholders. I am much more comfortable going down that path building more and more value into these ANDAs. Then I am to turn it over somebody else who would pay me a few million dollars now and then will have a lot more profit in the future.
Both of the partners we’re talking about today, both of the two front runners I should say, both of them contacted me. I did not contact them as a matter of fact I didn't even know that they had any interest at this time.
So there is a lot of interest out there and lot of people are calling. We need to prove this technology once and for all, get product to the FDA and after that when they see here is a product or two and the other 12 are coming that will seriously give our company value.
I'll miss out...meeting with a customer.
Lasers, where does it say Isradipine approved?
It reads
As of April 22, 2014 (the latest practicable date), Elite has been approved to manufacture, Phendimetrazine 35mg tablets at the Northvale Facility....
and that they have filed CBE30 for Isradipine...
AWESOME find Lasers!
No more going concern statement!
No more debt default concerns!
Nasrat getting it done!
Thanks Mocha for coordinating this.
Billion outstanding shares
Get real please
Not even close sir
So your motivation is to protect other prospective investors from hype.
1) we will have the 12 ANDA products launched by the end of the year.
Why is this hype? It really might happen.
2) we have 20 or 21 products in the market,
Who said that? One look at the pipeline page on elites website would tell you they have no where near that many at this time.
3) FDA and Big Pharma love Elite, and so forth.
Actually the CEO himself stated that the FDA is really behind them. But you don't have to believe me. Not aware of anyone saying Big Pharma loves Elite. But it's certainly not unreasonable to speculate they are keenly interested in Elites tech.
Well I hope elite has made you some retirement money or money for your loved ones after all this time and I hope you look forward to elites continued success.
@ Dr. PR
Got your PM.
As I don't pay I can't PM you back.
But thank you!
Actually I might get a Tesla!
What color Masarati should I get?
These are expected to be filed June/July by Epic:
Dantrolene Sodium
Loxapine
Hydroxyzine
For all I know they may have been filed.
Then there are 8 others that will be filed sometime after these I imagine.
Regarding Isradipine it may very well have received approval.
Elite tends to PR when they ship.
And the two undisclosed generics continue to await FDA approval.
Exciting times.