ELTP needs movement

it's difficult to make a buck in the pharma industry these days.  the internet has turned the stock market into a deadly vicious uncaring death pool waiting for you to be tempted to take a dip.  elite pharmaceuticals has been disappointing during the last 12 months, but it is not for apparent bad leadership.  obviously, Hakim made forecasts and did it in a bold, confident manner.  the FDA made him eat his words but thankfully Hakim stays positive without letting delays and rejection skew his path.  but it is so quiet lately, and the movement on the share price has been disappointing despite progress with the pipeline. 

here is a sample of posts from the day:

from: Inthe203  

HERE IS ONE ISSUE WITH THIS DRUG

CLINICAL TRIAL ISSUE:

With a fatty diet and the consumption of one pill, the patient had the sense that the drug wasn't 'kicking in' or effectively working. The patient will then take ANOTHER ONE or even a THIRD and still not receive the maximum effect of that first pill taken. IN THE MEANTIME, now three pills are consumed and the patient is now in jeopardy of an actual overdose without realizing it.

THIS IS WHY the FDA denied the approval.

THE FDA also clearly stated in their response that putting a WARNING LABEL on the bottle will NOT suffice, which poses a HUGE problem for ELTP.

There's no conceivable way around this issue. This is ONE of prominent loopholes ELTP is struggling with and unless the company is physically present to tell the consumer to watch their eating habits, this simply isn't going to end well.

As an investor, i'm extremely disappointed. I'm guilty of putting all my eggs in one basket (just shy of 7M shares) and i'm stuck holding the bag.

I'm looking for a miracle and NO ONE can challenge me on this. I'm simply telling you factual information that came out of the mouth of the FDA!

$ELTP$ 

by:  WeeZuhl

40,000 ER docs in the U.S. with at least as many NP/PA's working in the ED, probably a lot more. Approx 80,000 E.R. providers.

Now add in Urgent Care. 10,000 urgent care clinics in the U.S. Each clinic probably has an average four docs and as many NP/PA's, so we'll approximate another 80,000 urgent care providers.

Approximately 160,000 E.R. and urgent care providers in the U.S.. We convince just 10% to switch to SequestOx, and they write an average of one script per shift- about 20 scripts in a month of 20 pills each.

160,000 x 10% = 16,000

16,000 x 20 scripts x 20 pills x 12 months = 76,800,000 capsules per year.

Now set your price. Say $5/capsule (approx. 5x of generic oxy capsules).

76,800,000 capsules x $5/cap = $384,000,000 / year in revenue just from 10% of ER and urgent care providers writing 1 SequestOx #20 script per shift.

Now what happens if you get buy-in from 25% of the those providers? 50%? Now start to add in pain management, primary care, and orthopedics. 

by: aELmTPa  

The modified formula is already complete and trials have started comparing the new formula to the old one.

Elite will proceed immediately to complete in vitro and in vivo bridging studies required and expects to resubmit the SequestOxTM application later this year. The in vivo studies include bioequivalence and bioavailability fed and fasted studies comparing the modified formulation to the original formulation.

the modified formulation

the modified formulation

the modified formulation

 

Elite Pharma Release; Company Reports Positive Topline Results From A Pivotal Bioequivalence Study For A Generic Oxycontin

NORTHVALE, N.J, Jan. 17, 2017 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB:ELTP) today reported positive topline results from a pivotal bioequivalence fed study initiated in November 2016. The topline results indicate that Elite’s generic product is bioequivalent to the branded product, OxyContin® (extended release Oxycodone Hydrochloride). A fasted study was previously conducted in September 2016, also with positive results.

The study was a single dose crossover comparative bioavailability study of Oxycodone HCl extended release in healthy volunteers under fed conditions. The Elite product is a generic formulation of the branded product, OxyContin®, with strengths of 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg, and incorporates physical abuse deterrent properties. IMS reported approximately $2.5 billion in revenue for OxyContin in 2015.

“Following our recent announcement regarding a successful FDA meeting for our immediate release Oxycodone HCl product SequestOx™, I am now very pleased to announce these positive topline study results for an abuse-deterrent twice-daily Oxycodone,” said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “We intend to file an ANDA for this product later this year.”

A new way to pharma

ELTP chugs along and if you've followed along in the message boards, my deepest and most sincere condolences.  Best to let your investment breath, which also isn't to say not to demand the best from the CEO.  You're weak if ya do and weak if ya don't so worry not.  Elite has a ton going for it, they just are not the PR machine it used to be so wait for it.  When stupid fucktards make comments like "Why did it take 6 months to address the CRL I mean with expedited review it should have only take 3 months. What was Elite doing all that time?" you don't need to take time out of your day to respond, there is no need to educate, the fucktards are going to be fucktards when you let em.  I find the message boards, particularly on iHub, to have lost serious luster and when you just have a bunch of folks pushing against something that may or may not - at the end of the day facts good or bad will surface with out the hyperbole.  In a perfect world that is.. 

PR like the following don't say much of anything, so what.  If you can't draw as much based upon a first glance over of the PR maybe you need to be sucker punched anyway!

Elite Provides Update On SequestOx™ New Drug Application
NORTHVALE, N.J., Dec. 22, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) today announced the Company met with the U.S. Food and Drug Administration (the "FDA") on December 21, 2016 for an end-of-review meeting to discuss steps that Elite can take to obtain approval of SequestOx™. Based on the FDA response, the Company believes there is a clear path forward to address the issues cited in the July 14th Complete Response Letter ("CRL"). The FDA will provide minutes of the meeting by the end of January and the Company will issue a further update at that time.

SequestOx™ (oxycodone hydrochloride and naltrexone hydrochloride) is Elite's investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. The proposed plan submitted by the Company addresses items cited in the CRL dated July 14, 2016 for the New Drug Application (the "NDA") for SequestOx™.

"We are extremely pleased that there is a path forward to seek FDA approval of SequestOx™," said Nasrat Hakim, President and CEO of Elite. "Based on the guidance received from the agency, Elite will begin to execute the proposed plan immediately."


So you see, no need for gratuitous expletives, ad hominem attacks, or other displays of internet weakness.  Push for the best, demand the best from your CEO, work together in the boards for a better day by using the facts, yes especially those hard to swallow facts.  Those come in handy and then find your trends or just sit back and show confidence in where your money is sitting.

FDA and Elite have agreed to a clear path forward for SequestOx

<EOM>