[b]I hate to advocate drugs, alcohol, violence, or insanity to anyone, but they've always worked for me.[/b]
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The ONE thing Chris Christie has done right and been an advocate for. New Jersey is a leader among the states in the war on opioid addiction.
I have it right here N2K.
Complaint against Nasrat Hakim:
Coffee always running low at North Vale facility.
Need better more reliable supply.
End of complaint....
CR845 approved it will effectively render all opioids, including abuse deterrent ones absolete
There are also non-profitable companies on NASDAQ that are valued
in dollars. Your point?
Elite has multiple opioid ADF drugs in their pipeline. Extended release drugs yet to be counted. They get this IR SequestOx and the others in their pipeline are likely to be much easier.
What is the prescription opioid abuse like in the US? Bad and getting worse.
Philly DA race..... one of the hot topics is the pill mills that are rampant. Big Pharma is another topic of the Philly DA race.
Go after Big Pharma. So if Elite has a solution... whose formulation is likely to be dominant? OxyContin tamper resistant? or SequestOx ADF?
This is the ELTP board.... not the AMFE board.
As I was told back in 2011 when Jerry Treppel was CEO, management
of Elite is deliberate. I do not think ANYTHING has changed.
One of the reasons I started investing. Elite management was slow
but deliberate. Now they are just being deliberate.
Buying pressure continues. No distant dream here. Bought a few more
for my Roth.
I'll keep adding until something tells me otherwise.
Like the Kentucky Derby winner...... Always Dreaming.
Hollow candle....... buying pressure.
BINGO!
$ELTP's SequestOx-II, 3 proposed Tmax solutions, have all been thoroughly successfully tested with In-Vivo guidelines on healthy persons as per the FDA guidelines prior to the Dec 21, 2016 EOR meeting. Camargo did the trialing.
The FDA at the EOR meeting said good, pick one, and then proceed to the official Tmax FDA trial with 45 persons.
Yes indeed Couch. Absolutely.
Elite had also done in house studies of naltrexone leakage way back in the Jerry Treppel days.
These folks saying companies like Elite don't do in house studies prior to putting the formulation out for testing are WRONG.
Every company I know does them.
Elite knew there was no leakage of naltrexone prior to HAL/BE studies because they had done extensive in house testing.
Another example, my company is doing in house testing on syringes. Both the glass and the function are tested. Glass has to be within heavy metals guidelines. Syringe function has to be consistent and safe.
Just as Elite knows this reformulated SequestOx is well within FDA Tmax guidelines.
Companies just don't wing it and go into BE studies without prior testing. Liability issues would be off the charts.
Gee, If that's correct the Nasrat has made even more goofs that I thought.
$38 right around the corner
So I take it Zombie SequestOx was a fresh breath of air as well?
Whatever......
Is it a matter of brilliance? Or more a matter of one does what they have to do in order to obtain ones goal? There are prices for everything in this world. Objectives don't come without some sort
of payment.... either now or later.
And everyone also has the freedom to take their chips off the table at any time during this game. It is up to each individual to do what he/she thinks best.
Again concocted logic by saying a PROMO helped the stock rise.
Unsubstantiated and just not true.
The GOLDEN CROSS approaches and some are in serious damage control trying to either cover short positions or grab more ELTP before the 50 day goes above the 200 day MA.
Fear Uncertainty and Doubt....... thanks for that Couch. Very true.
This is all stock market psychology 101.
Shake the tree and see if the weak hands sell.
Steve, I make sure my barn door is closed at all times. Don't want
the horse out of the barn.
Suggest checking before leaving home.
WRONG. One time events are not considered to be normal revenue.
They are one time events that contribute at ONE time to total revenue. And I believe Elite had to split their last smilestone up
over quarters. But still a one time event.
See... the thing with another financing agreement with LPC is that you have those who flip out and say "oh no, more dilution".
Well it takes money to make money. It takes balz to do what needs to be done.
In the end the Company feels that the expenditure in shares is WELL WORTH it. The money they stand to get back will make this deal-EO
with LPC seem like a peanut in comparison.
So again.... why hasn't the price per share moved DOWN with additional financing?
Elite would not bother to have a second shift if things were not going so well. If they believed it to be futile.
FACT: They do not believe it to be futile. They believe their future is coming.
Elite is in the right spot at exactly the right time.
Prescription opioid addiction is out of control. Elite is close to the perfect storm.
Yepper... exactly rrr2003. More BS.
Fear uncertainty and doubt...... that is what they do to shake the tree and get those weak hands to sell.
Smilestone payments are NOT considered to be "normal revenue".
They are a one time event that happens at the conclusion of a set goal others pay Elite to accomplish. Very bonus like.
So no R&D or production/packaging goes on during this second shift.
All nightclub/casino action until midnight arrives. Maybe Elite has an escort service too nammy.
Couch, Elite's second shift is all a fantasy. Even if they had a second shift, which they do, they do nothing but play Texas Hold'em.
The North Vale site doubles ae a nightclub/ casino at night.
This is not your typical start up pharmaceutical. This company is thinking outside of the box!
So any logic that anyone concocts without facts is applying ones own logic. Oh I get it, that means it must also apply to the person
pointing that out as well. LOL LOL
Elite needs cash because their expenses are rising
Hollow long candle indicating buying pressure.
Yeah.... the Elite execs just walk in the meeting door and ask one question. The FDA says "yes" and that's the end of discussion.
Elite execs walk back to their vehicle and leave.
Seriously nammy?
Reality check.... there is a serious discussion as to solutions to
a CRL between the FDA and the pharma. Yes. the FDA does give guidance on what the pharmaceutical may need to accomplish during testing. What options are available...
Elite had 3 solutions.... of those 3 the FDA liked all.
It is not cut and dry as you propose it to be.
GOLDEN CROSS = BULLISH!
Oh don't you worry about little ole me. This must be the giant dead cat bounce before 2 cent shares. LOL
Patience nammy. Patience. As the 50 and 200 day get closer.
Could be nammy, but I highly doubt it will stick this time around.
First it was just a labeling issue. Now it is persistent safety concerns? Can't make this stuff up. There was only ONE "safety concern" and that was the Tmax issue for "Zombie" SequestOx.
Pretty soon we all get to see what the FDA does with the new data.
There are some that speculated about BE studies completed earlier.
BE studies that have nothing to do with anything Elite currently has on their docket.
I believe shareholders will get an answer soon. Among the ANDAs filed will be the nod for Percocet.
There are other speculations about the FDA not wanting just one pharmaceutical having a monopoly on a tamper resistant formulation of oxycodone. Could Elite/Epic (PuraCap) be one of those pharmaceuticals the FDA gives a green light to?
Golden cross coming.
Thanks mrwrn. A rejection is a rejection simple as that. Some formulations are just unfixable. They don't live up what the manufacturer claimed.
Since Elite met with the FDA and cited 3 means by which they could get approval with SequestOx, the FDA in turn gave them guidance as to the best approach to getting that approval.
We are in the midst of seeing those results very soon.
So the FDA no longer flat out rejects ANY submission?
WRONG! They still flat out reject. No CRL needed for something unfixable. THAT is a matter of FACT! Not fiction.
The golden cross approaches which is BULLISH. Elite is getting
CASH they need for something. What could it be namtae?
Instead, they issue a CRL!!
Or do you think a CRL means YES??
Could be just the positive BE data Couch.... but something tells me there is also another thing going on.
All in all a positive no matter how one looks at it.
Hope my gut feeling is right about this. If the company were in trouble insiders would be dumping out.
Nothing of the sort.
Elite needs cash for something. NH will not disclose this during a Q&A either. He holds everything close with a poker face.
No tells.... not even in the 8K.
Complete response letter is not in any way shape or form a denial.
If the FDA said NO without a CRL then Elite would be DOA with regard to SequestOx.
Golden cross approaches..... wonder what it could all be about?
Certainly not solely about SequestOx BE results......
My take on this is that something else is afoot.
Something else looks to be going on, and as per usual NH holding his cards close to his vest.
Since Elite cannot manufacture the cash they need they have to go it another way. They need the cash for something.
What could it be?
Golden cross cometh. No denying that. Very bullish if it happens. Looks to be soon too.
Hmmmmmmmmmm...........
Merger or Takeover: PuraCap