all my posts are my opinion... 95% are based on TA
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a lot of investors are waiting for the first to hit imo , after the sell off with allay clearance , the price will still very cheap to buy and a lot of people will take for granted that all the other fillings will get aproved with bigger markets.
im trying to stay positive , arent we way undervalued !!! im just waiting to nri to get approved ( if if if ) to buy more shares..i have a feeling that we'll have to wait longer for fda approval but maybe the 3 clearances could come at the same time..let me dream let me dream
i think what he means by ' inapropriate ' is that he simply just can't talk about it since they are auditing
Ryoko , i have a question . i see on YMB a list of questions that you guys want to submitt to AW and JN . What if they guys are a lot under pressure to respond all these questions and take a long time to do it . i think the ''lunch'' with shareholders could have open a gate for a lot of investors to constantly harrass them . Do they have the time to be that transparent ? i mean none of my other stocks are that communicative with shareholders.
we knew that , thanx GL
where are you?
why don't you contact yourself Andrew W. first time in the morning ?? you will find all the contact you want on these infected boards. even if there was no meeting ( i havent learned anything new that would push me to buy or sell a single share ) it won't change the fact that the company has products waiting for clearances and that will be your payday.. GL
i agree.. this is a buy now , cross youir fingers for first approval , then fold it and put it asie until one year from now...
what does it have to do with biel....he is an external consultant he works for other companys too...
ok then , i dont want to do any projections...but what will the revenue be when FDA approves the 3 devices ( q1 2010 ?? )and air the infomercials..isn't there too much shares to reach a 1$ per share even with that many sales ??
i fully understand your point , but we know that the CEO cant say anything new to a shareholder ..but to me it just reinforce the point of why we have invested in that company and should continue to accumulate at these prices
for what its worth , 2 shareholders of biel went to a meeting with Andrew Whelan
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_B/threadview?m=tm&bn=66222&tid=93338&mid=93338&tof=6&frt=2
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_B/threadview?m=tm&bn=66222&tid=93339&mid=93339&tof=4&frt=2
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_B/threadview?m=tm&bn=66222&tid=93340&mid=93340&tof=1&frt=2
its the buy/sell indicators
yeah...the song ''i got a feeling'' is getting pretty old now
what is that voice repeating the same thing in my head ?? ...great things happen to those who wait..
it is everywhere tonight..it seems so good to be true , but my lack of experience could play me tricks..a run like that all of a sudden on big volume and no news bring me questions. but i dont have yet the knowledge to analyse it preety well.
you are talented traders and want to hear/share opinions on this stock
thanx in advance!
110% up today by end of day.
ELTP DD - Google Docs
Looking at ELTP one can ask, "How can a biotech with a VERY DEEP PIPELINE OF PRODUCTS, 2 OF WHICH ARE PARTNERED UP ALREADY, also having secured 5 UNITED STATES
PATENTS and have pending applications for 5 and seven foreign patents be can penny stock?" The simple answer, "I HAVE NO IDEA, BUT TIME TO BUY IT NOW AND HOLD LONG SO I
CAN BE REWARDED IN THE NEAR TERM."
Well the near term is starting NOW, with the Annual Meeting of Stockholders of Elite Pharmaceuticals, Inc.being held at the Company’s headquarters at 165 Ludlow Avenue, Northvale,
New Jersey 07647, on October 23, 2009 at 10:00 a.m. be ready for news on PENDING PATENTS & THEIR TOP LINE RESULT FOR PHASE III of Oxycodone CR (Currently there is no
abuse deterrent oxycodone product available commercially. Elite estimate that the U.S. market for controlled-release, twice-daily oxycodone was about $2.8 billion in 2008.!!!)
****HISTORY OF OXYCODONE****
In May 2005, the FDA accepted Elite’s IND for ELI-216, Elite’s once-a-day, abuse resistant oxycodone painkiller. After the acceptance of the IND, Elite completed two pharmacokinetic
studies and a euphoria study in recreational drug users to assess the abuse deterrent properties of ELI-216. Elite met with the FDA in October 2006 and received guidance for the ELI-
216 development program and in November 2007, Elite reached agreement with the FDA on a Special Protocol Assessment for the Phase III protocol for ELI-216. Elite is currently scaling
up the product and it will begin its Phase III studies for this product upon the completion of a joint development and distribution agreement. Currently there is no abuse deterrent
oxycodone product available commercially. Elite estimate that the U.S. market for controlled-release, twice-daily oxycodone was about $2.8 billion in 2008.
With potential release of news of PHASE III (LONG TIME IN THE MAKING & $2.8BILLION MARKET and PATENTS, I am LONG on ELTP) ELTP WILL RETEST 52-week high of $.34,
currently sitting at .13!!!! 200%+ gainer coming these next few days.
Authorized 210Mil shares as of June 30, 2009, actually Float is much less. This will be a mover, I dont think anyone is selling!!
***GLIMPSE INTO THEIR PIPELINE***
Programs Under Development
Branded Products (a)
TOP LINE PRODUCT:
-Oxycodone CR
Once a day
NA
Pain
NDA
Phase III pending
-Abuse Resistance Product for use with Oxycodone or other opioids N/A
Pain
NDA
Phase II
-Diltiazem
Once a day
Cardizem CD®
Cardiovascular
ANDA
Pilot BE study complete
-Lodrane
Once a Day
N/A
Allergy
NDA
Launched
Partnered up with ECR Pharmaceuticals
Lodrane 24D
Once a day
N/A
Allergy
NDA
Launched
Partnered up with ECR Pharmaceuticals
Undisclosed
Twice a Day
Undisclosed
Infection
ANDA
Pilot BE study complete
Preclinical testing refers to studies done before initiation of any human studies. Pilot Phase I studies for the NDA products are generally preliminary studies done in healthy human
subjects to assess the tolerance/safety and pharmacokinetics (PK) of the product. Additional larger studies in humans will be required prior to submission of this product to the FDA for
review. Pilot bioequivalence (BE) studies are initial studies done in humans for generic products and are used to assess the likelihood of achieving bioequivalence for generic products.
Larger pivotal bioquivalence studies will be required prior to submission of the product for FDA for review.
***PATENTS***
ELTP have secured five United States patents and have pending applications for five United States patents and seven foreign patents. Two of the United States issued patents have
been assigned for a fee to Celgene Corporation for the pulsed released delivery of methylphenidate.
The pending patent applications relate to four different control release pharmaceutical products on which we are working. Included among these patent applications are applications for
the U.S. patents relating to formulations for delayed and sustained release of drugs. In addition, an application for a U.S. patent for a narcotic antagonist product that we are developing
to be used with Oxycodone and other narcotics to minimize the abuse potential for the narcotics was filed.
Elite Pharmaceuticals: Home
****MOVING IN THE RIGHT DIRECTION - RECENT NEW APPOINTMENTS OF CEO & CSO****
NORTHVALE, N.J., Sep 21, 2009 (GlobeNewswire via COMTEX) -- Effective as of September 15, 2009, Elite Pharmaceuticals, Inc. ("Elite" or the "Company") /quotes/comstock/11k!eltp
(ELTP 0.09, +0.00, +1.09%) appointed Jerry I. Treppel as its Chief Executive Officer, and Ashok G. Nigalaye, Ph.D. as its Chief Scientific Officer. Jerry Treppel, a Wall Street veteran with
over 20 years' experience as a specialty pharmaceutical analyst, has served on Elite's Board of Directors since October 2008 and has been the Company's Chairman since November
2008. Dr. Ashok Nigalaye, a licensed pharmacist with extensive formulation experience in the pharmaceutical industry, has served on Elite's Board of Directors since June 2009.
Since 2003, Mr. Treppel has served as the managing member of Wheaten Capital Management LLC, a capital management company focusing on investment in the health care sector. In
October 2008, Mr. Treppel was also appointed managing director of Ledgemont Capital Group LLC, a boutique merchant bank that provides access to capital and corporate advisory
services to public and private companies. Over the past 20 years, Mr. Treppel was an equity research analyst focusing on the specialty pharmaceuticals and generic drug sectors at
several investment banking firms including Banc of America Securities, Warburg Dillon Read LLC (now UBS), and Kidder, Peabody & Co. He previously served as a healthcare services
analyst at various firms, including Merrill Lynch & Co. He also held administrative positions in the healthcare services industry early in his career. Since 2003, Mr. Treppel has served as a
member of the board of directors of Akorn, Incorporated /quotes/comstock/15*!akrx/quotes/nls/akrx (AKRX 1.54, -0.02, -1.28%) , a specialty pharmaceutical company engaged in the
development, manufacturing and marketing of branded and multi-source pharmaceutical products and vaccines. Mr. Treppel serves as the Chair of Akorn's Nominating and Corporate
Governance Committee and as a member of its Audit Committee and Compensation Committee. Mr. Treppel holds a BA in Biology from Rutgers College in New Brunswick, N.J., an MHA in
Health Administration from Washington University in St. Louis, Mo., and an MBA in Finance from New York University. Mr. Treppel has been a Chartered Financial Analyst (CFA) since
1988.
Since July 2008, Dr. Nigalaye has been the President and Chief Executive Officer of Epic Pharma LLC, a manufacturer of generic pharmaceuticals and Elite's strategic partner pursuant
to the Epic Strategic Alliance Agreement. From August 1993 to February 2008, Dr. Nigalaye served as Vice President of Scientific Affairs and Operations of Actavis Totowa LLC, a
manufacturer of generic pharmaceuticals, where he was responsible for directing and organizing company activities relating to pharmaceutical drug manufacturing, regulatory affairs and
research and development. Dr. Nigalaye currently serves as a director of GTI Inc., a privately held company. Dr. Nigalaye holds a B.S. in Pharmacy from the University of Bombay, an M.S.
in Industrial Pharmacy from Long Island University, and a Ph.D. in Industrial Pharmacy from St. John's University. Dr. Nigalaye is a licensed pharmacist in the State of New York.
http://www.marketwatch.com/story/eli...cer-2009-09-21
****ANNUAL MEETING NEWS Tab #4****
What makes me believe news on topline results or patent
"4. The transaction of such other business as may properly come before the meeting or any adjournment thereof that was not known a reasonable time before the solicitation. "
Schedule 14A
ELITE PHARMACEUTICALS, INC.
NOTICE OF ANNUAL MEETING OF STOCKHOLDERS
September 8, 2009
NOTICE IS HEREBY GIVEN that the Annual Meeting of Stockholders of Elite Pharmaceuticals, Inc. (“ Company ”, “ we ”, “ our ” or “ us ”) will be held at the Company’s
headquarters at 165 Ludlow Avenue, Northvale, New Jersey 07647, on October 23, 2009 at 10:00 a.m., to consider and act upon the following:
.
4.
The transaction of such other business as may properly come before the meeting or any adjournment thereof that was not known a reasonable time before the solicitation.
All stockholders of record at the close of business on August 24, 2009 are entitled to notice of and to vote at this meeting and any adjournments thereof.
You are requested to sign and date the enclosed proxy card and return it in the enclosed envelope.
Our Annual Report on Form 10-K for the fiscal year ended March 31, 2009, and our quarterly report on Form 10-Q for the three months ended June 30, 2009, which are not part of the
proxy soliciting materials, are enclosed.
BY ORDER OF THE BOARD OF DIRECTORS
/s/ Carter Ward
Chief Financial Officer and Secretary
September 8, 2009
ELITE PHARMACEUTICALS INC /DE/ (Form: DEF 14A, Received: 09/08/2009 17:24:56)
Digging Deeper in their recent 10Q filing:
Elite has two products, Lodrane 24® and Lodrane 24D®, currently being sold commercially, and a pipeline of five additional drug candidates under active development in the therapeutic
areas that include pain management, gastro-intestinal and infection. Of the products under development, ELI-216, a once-a-day, abuse deterrent oxycodone product, and ELI-154, a
once-a-day oxycodone product, are in clinical trials and Elite has completed pilot studies on two of Elite’s other generic product candidates. Elite has also submitted an ANDA with Elite’s
co-development partner, The PharmaNetwork, for a pain management generic product. The addressable market for the pipeline of products is approximately $6 billion. Elite’s facility in
Northvale, New Jersey is a Good Manufacturing Practice (“ GMP ”) and DEA registered facility for research, development and manufacturing.
In January 2006, the FDA accepted Elite’s Investigational New Drug Application (an “ IND ”) for ELI-154, Elite’s once-a-day oxycodone painkiller. Elite has completed two
pharmacokinetic studies to evaluate ELI-154’s controlled-release formulation, of which the most recent study was completed in 2006. Elite is currently scaling up the product and it will
begin its Phase III studies for this product upon the completion of a joint development and distribution agreement. Currently there is no once-daily oxycodone available commercially.
--------------------------------------------------------------------------------
In May 2005, the FDA accepted Elite’s IND for ELI-216, Elite’s once-a-day, abuse resistant oxycodone painkiller. After the acceptance of the IND, Elite completed two pharmacokinetic
studies and a euphoria study in recreational drug users to assess the abuse deterrent properties of ELI-216. Elite met with the FDA in October 2006 and received guidance for the ELI-
216 development program and in November 2007, Elite reached agreement with the FDA on a Special Protocol Assessment for the Phase III protocol for ELI-216. Elite is currently scaling
up the product and it will begin its Phase III studies for this product upon the completion of a joint development and distribution agreement. Currently there is no abuse deterrent
oxycodone product available commercially. Elite estimate that the U.S. market for controlled-release, twice-daily oxycodone was about $2.8 billion in 2008.
Strategy
Elite is focusing its efforts on the following areas: (i) development of Elite’s pain management products, (ii) manufacturing of Lodrane 24(R) and Lodrane 24D(R) products; (iii) the
development of the other products in Elite’s pipeline; (iv) development of the eight products with pursuant to the Epic Strategic Alliance Agreement and (v) commercial exploitation of
Elite’s products either by license and the collection of royalties, or through the manufacture of Elite’s formulations, and (vi) development of new products and the expansion of Elite’s
licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.
Elite is focusing on the development of various types of drug products, including branded drug products (which require new drug applications (“ NDA ”) under Section 505(b)(1) or 505(b)(2)
of the Drug Price Competition and Patent Term Restoration Act of 1984 as well as generic drug products (which require abbreviated new drug applications (“ ANDA ”)).
Elite believes that its business strategy enables Elite to reduce Elite’s risk by having a diverse product portfolio that includes both branded and generic products in various therapeutic
categories and build collaborations and establish licensing agreements with companies with greater resources thereby allowing Elite to share costs of development and to improve cash-
flow.
Epic Strategic Alliance Agreement
On March 18, 2009, Elite entered into the Epic Strategic Alliance Agreement (amended on April 30, 2009, June 1, 2009 and July 28, 2009), pursuant to which Elite commenced a strategic
relationship with Epic, a pharmaceutical company that operates a business synergistic to that of Elite in the research and development, manufacturing, sales and marketing of oral
immediate and controlled-release drug products
ELITE PHARMACEUTICALS INC /DE/ (Form: 10-Q, Received: 08/19/2009 16:57:32)
dont wanna miss the boat either...but why are you pumping that much ?
thank you ryoko...imo it also means that they have nothing to hide and that's a great sign of them moving forward..damn does the stockmarket requires patience!! good luck with your investment
being new to all this..what is audited ?
thanx in advance
Hi MOD can you put that report on the i-box ?
http://www.sharefile.org/showfile-2034/file.pdf
theres your report
this could collapse...hope not
'' long'' in the stockmarket just means that you hold your shares ...but it does not mean long time , just that you have them
hey very nice link thanks...we definetivly need to spam her lol
http://www.sharefile.org/showfile-2034/file.pdf
reuters report on BIEL
well i predicted the selloff this morning , but i would have never thought we would be up 5% at 2pm...let's hope we break the 8's before the end of the week..do you guys with L2 see something special ???
do you guys with L2 see a lot of buys coming in ?? thanx
yes i notice it after my edit period i missed a zero..thanx anyways
meatalex i still don't see where you place the pps after approval
ok thanx! GL with your investment
my next step after that is to learn TA ..and thanx for your charts by the way . question about that lol i saw that the RSI is around 40..that's oversold right?
right on spot ! i had a lot of time to think about that since im holding long , its not that i am greedy , its just that i started with almost nothing and need money to play freebies..
ill wait the FDA approval to...but thats because i have no choice , im starting to really understand the stockmarket , hope for me is the last time i fall in luv with a stock .
For BIEL , i hope JN turned off his ringer..cuz it will ring a lot. in his post he mentionned questions fda asked for the second set of fillings , but never answered back for the allay..
the real hard bleed stopped just after that..it may be coincidence since the stock does not move on board messages, but who knows . my speculation is that tomorrow the sell off could continue in the morning.
so you are talking about 6X the price after approval right ?? that would make sense...with all the people that will be chasing the stock we could see life time highs
that is what i am assuming from what im reading from Joe's posts on YMB...
at least he quit giving time estimates, that will keep SH on edge
there is our answer , another Joe post
The other important item relative to FDA - It appears FDA has assigned the same person to evaluate Allay and ActiPatch. Our lawyers also consider this to be positive in that questions and answers from one will be used for the other. The bottom line here is that ActiPatch and Allay both use a 3 volt battery that hurts no one. We have a 100% safety record. We have proven that the device works. Many of you on this board have used it. We do not believe FDA is going to say we can't sell it for use on your foot when FDA has been saying it is okay to place on your eye, which of course is directly connected to your brain. We have to wait for the FDA process to work its way through. Like I said, we remain very positive - Joe Noel
and i saw your post on YMB too..and that's a question i wonder too..he mentionned the second set of applications...he did nont mention allay patch..hmmmm msg to Ryoko