[b]I hate to advocate drugs, alcohol, violence, or insanity to anyone, but they've always worked for me.[/b]
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$2 Billion dollar loss right. ($2 Billion). And what was Pfizers point?
N2K bingo!
Companies have to take future revenues into account. To sell ones company based on 1 year projected revenues after the launch of a product would be irresponsible and plain dumb.
Add 2-3 more ADFs to this equation and one also has to give them time as well. Future sales and what they will bring to the Elite table. Then Elite can talk turkey with Big Pharma.......
for a nice big BUYOUT price. $$$$$$$$$$$$$$$$$$$$$$$$$$$$.
Actually a $5 billion offer is rather cheap considering the buyer gets all of the premiums for all of the hard work done by the company being bought.
$5 billion is nothing. Elite gets a few ADFs out there on the market and possibly does one more thing to cement a buyout offer that will not be coming for a while. THEN once all of that is done we see what the buyout offer is.
The company I work for is constantly making strategic acquisitions in order to position themselves for the future.
Already had a $1.5 billion offer about 2 years ago. This company I work for has nothing in comparison to what Elite has in its multibillion dollar platform. My company is a very small time player. Elite on the other hand may possibly be a bigtime player in the not so distant future in the ADF sector.
nroland88 nice find thank you.
Excellent 60 minutes tonight. Focus is on the heroin epidemic...
but more importantly the prescription opioids that lead to this
epidemic.
Current problem described by one nurse as a hurricane.
http://www.cbsnews.com/videos/heroin-in-the-heartland-smart-guns-the-slave-ship/
Just sell when the big guys sell. Will not be for a while IMHO.
Follow the money. The VERY smart money.
Seeking immediate rewards? In the wrong stock.
Patience is always the key. Elite is close. 2016 into 2017.
I can wait a bit longer.
Heidi she can have her email set up that way. My manager does it all the time.
It means she is just not answering OR could be in a quite period.
Wonder what she could be so quite about? Hmmmmmm hehehe
Good points mrwrn2010. Follow the money. Build it and they will come.
All good points.
Rich 3 years ago Elite the pharmaceutical company was nowhere near what it is today. Their ADT although patented still had to go through stages.
Today Elite the pharmaceutical company is in capable hands. Their generic portfolio is growing in both scope and revenue.
The opioid ADF is in the process of evaluation by the FDA.
Been hearing the same thing for three years? Not really. The FDA did not have the 505(b)2 for review. Elites revenues were not growing at triple digit rates quarter after quarter.
Its only lately that long term shareholders have begun to emphasize all of these key points.
I understand that there are those who must do what they have to do... that is the nature of the game.
Meanwhile I just sit and wait. Buy when/if I can... accumulate and hold for the long term. In this sector nothing happens overnight..... except buyouts and mergers. For product it is a waiting game.
John I could tell those three MMs were retail by their names.
Penney Macy and Boscov. LOL LOL
Follow anothers guidance and make their mistake.
Like in 2001 the experts were saying to stay the course and ride the market out.
Now some say stay in cash. Take their advice and make their mistakes. Misery likes company. LOL LOL
Rich "what is fast?". I guess we will soon find out.
How fast is fast? I dunno. 12 weeks? 4 months?
Todays SECRET word is "fast".
Stay tuned......
Yes Dr. Thorfin... Elite has come a long way from nothing.
They still have a ways to go... but things have changed so much more for the better.
Nasrat - THE CLOSER
Actually it is not an NDA... its a 505(b)2.
Confirmed..... a gross misinformation is a 144.
LOL
Incorrect..... try again. The FDA requested Elite do these BE tests.
Oh and about the data being published that you had such a hard time with Elite not publishing for these tests?
There was a very good reason....
Man oh man........ wow.
Gman24 I think the whole thing is misconstrued as to what Nasrat meant when he told shareholders 2 weeks acceptance of the 505(B)2.
In reality I think he was talking about the application for the filing itself. The FDA has given a 6-12 week acceptance window for the filing.
Being that this is the first filing for Elite that is probably why the fee was waived. $2.3 million is $2,3 million (big smile).
BTW I was wrong about the INDA. Even though this was filed with the FDA before the testings started it does not mean that the FDA was kept in the loop with data generated during testing.
It does give the FDA the opportunity to assist Elite in guidance
criteria it may like to see in the testing procedure.
The FDA ultimately reviews the data in the 505(b)2 filing as I understand it, which they are now doing.
Maybe Elite does go the full 6 month route. Maybe not.
Lasers whatever Elite files with the FDA is the property of the agency for review. The only way another pharmaceutical can view that data presented to the FDA is if the data is published.
Is Nasrat one smart cookie or what? He knows exactly what he is doing............ he is an EXPERT.
Like the BE data for ELI-201 that something happened to. LOL LOL
An IND basically allows Elite to perform studies with a new formulation of drug interstate, which Elite did.
It also allows Elite to keep the FDA informed on testing so they may use the FDA's guidance.
I believe the FDA has been kept in the loop so to speak during this whole process.
The 505(b)2 for ELI-200... which Elite has had help in doing from Camargo... is now a packet... probably rather larger... sitting with the FDA for review over the next 6-12 weeks awaiting acceptance by the FDA within that 12 week max period.
Once deemed accepted by the FDA with no further data needed the ball is then in the FDAs court.
Tic Toc Tic Toc
That is the max time before approval. Remember Elite filed an
IND with the FDA a while back before testing even started for ELI-200.
Everything is right on schedule now matter how it is spun. Some just dont know what they are talking about.
One has to fill out an application and pay an up front fee... which in Elites case was waived. After the application is reviewed and accepted then Elite "will immediately" submit their
505(b)2 for a review of 8 -12 weeks.
When the FDA gives the green light with nothing further for Elite to do to satisfy the FDA then the FDA accepts the filing.
Approval can happen anytime after the filing is given the official "review and accepted" by the FDA 6-12 weeks from now.
Approval can happen that quickly or it can be stretched out to 6 months.
There was IND filed with the FDA from the beginning.
Again........ APPLICATION was approved and accepted for this NDA filing. On schedule as Nasrat said it would be.
Bonus is that ELite has $2.3million to spend on another NDA
submission. What is it that has you confused? Everything is moving right along.
If you dont trust Nasrat then dump out and find another play.
Yeah you really DID miss it then......
APPLICATION accepted and approved so that Elite will immediately submit the filing for review.
Difference between application and 505 b 2 data for submission...review.... then acceptance....... then approval.
Got it? Your welcome.
What I really interesting is now that the NDA application was accepted and approved so that Elite could submit the filing... FDA gives a 6 week to 12 week REVIEW of the filing to see if there is anything Elite needs to do further.
So confident with Camargos help everything will go smooth. Those 505 b 2s are Camargos bread and butter.
But one thing strikes me as odd.. why such an opened window for the review? Up to 12 weeks for a review the FDA should already be well versed on.
Did Elite not file an IND for ELI-200 with the FDA? I believe they did.... didnt they.
Lots of things one could do in a 12 week period after thorough review of what they have already been versed on.
Wonder how long till approval of ELI-200?
SCHH my question was valid? Not hardly. In the United States of America immediate means NOW.... STAT....STATIM.
No clarification needed over here.
-------------------------------------
@John who just took a position in Elite....
Stop Losses will be taken out at some point. Thanks for the heads up John. Hope to have some money freed up soon. Looking to always add to my position.
Never ever use a stop loss unless you are VERY uncertain and have not proper DD. Stop losses are an MMs best friend.
Rich.... don't be such a Debbie Downer. Some things that may help cheer you up going into the February CC.... 2 more generics to launch..... possibly another quarter of record breaking revenue...
possibly other news during the CC on what shareholders can expect
on other NDA filings in the near future.
Its all good Rich........
Immediately means immediate as in now. NEXT!
Yes... by all means go by the company PR. "will immediately"
Now how immediate is immediately? LOL LOL
NEXT!
Like in instantaneously.... immediately.
"Will" "immediately".
Thanks for pointing that out Doc.
Application was submitted reviewed fee waived.
Notice the word "immediate"? How immediate is immediate?
LOL LOL
Next!
Application submitted accepted with NDA fee waived. NEXT!
The NDA application was submitted and accepted with a waver of the fee granted. No "rookie mistake" there. Everything is as Nasrat said it would be. Now with $4.8 million in the Elite coffers.
Rich try to spin it any which way you wish... Elite is right on schedule. Others may spin it as a "rookie mistake" or that shareholders were "lied to". Total garbage. Everything is as it should be with $2.3 million in savings to boot.
N2K very good post. Also keep in mind that approval can happen ANYTIME after FDA acceptance of the NDA is official. Basically the FDA will be reviewing the NDA anyway to see if Elite needs anything more.
Think of it that way.
6 to 12 weeks is not a long time at all. Filing is NOW with the FDA. That we know. How many larger pharmaceuticals are able to accomplish what Elite did in the time frame Elite did it?
I will answer.......not many if any at all. That includes the Big guys.
First one is always the longest. This is a new technology being introduced to the market here. Nothing else quite like it.
Keep that in mind.
Well now working hard are we? So the FDA waves the fee which is an option on their part and saves Elite over $2.3 million which Elite can use to apply to another NDA after ELI-200 is accepted and approved. Very good.
AND 5 different dosings of oxy to boot. Camargo was/probably still is involved in helping Elite bring ELI-200 to market.
So basically this is a waiting game from here on out. With two more generics on the way should not be too bad a wait.
So Elite saves >$2.3 million in fees and in about 6 -12 weeks receives another $2.5 million from Epic in milestone payments.
Not bad. Eh? Not bad at all. Im sweating. LOL LOL
Wow... count those fractions of a penny down while you can.
And be sure to watch every single tic. LOL LOL