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Interesting thought, but I find that hard to believe. Plan for the worst & hope for the best.
That's how I understand it as well, but isn't the FDA surpassing their 60-day window of acceptance notification with the following 8-k wording. Sounds like it may not get accepted for review until mid-April.
"FDA notification regarding acceptance of the submission for review is expected to take 6 to 12 weeks."
Gone went the claims that ELTP followed the general market once it entered the OTC. No one has been claiming that.
Isn't that only the earliest date within the range provided by the FDA? Worst case scenerio is we hit the back end of the range which I believe is mid-April.
Or they can just leverage the BP's marketing. Not too far off.
Any thoughts as to the final section of the 8-k? What is the "specified transaction, either completed or proposed"?
During the fiscal year ended March 31, 2015, and in the subsequent interim period from April 1, 2015 through and including January 29, 2016, the Company did not consult Buchbinder Tunich & Company LLP with respect to the application of accounting principles to a specified transaction, either completed or proposed, or the type of audit option that might be rendered on the Company's consolidated financial statements.
A resounding yes. What claims are you making regarding any untruthfulness in the completed trials? This string is an absolute joke and clearly an alias of JL or doc as they speak identically and make similar unsubstantiated false claims.
Not for a company of this size. That is a pretty sizable piece of the cashflow for one individual. If he delivers on ELI 200 approval then it's a different story as he has earned it, but should be tied to options. I personally think he is paid way too much for company of this size.
Who is claiming 100% prevention? Even Elite doesn't claim that. That is why it is called a deterrent. It is a much better deterrent than any tech in the market now. No solution is perfect yet, but this is by far the best tech in years to hit this industry.
Please feel free to expound on why over 30% of doctors prefer the pharmacological approach?
Thanks. I don't recall that statement. Thanks to others for responses.
I understand the benefits to Epic insiders, but not so much Elite insiders. What do you think is in the works?
What are the benefits of a potential reverse merger with Epic? It avoids SEC regulation for Epic to go public. I would worry about what happens to shares of ELTP after such an event. Any risks or concerns of which we should be aware?
Job posting detail on Indeed:
Technical Services Specialist
Elite Pharmaceuticals, Inc. - Northvale, NJ 07647
Apply with your Indeed Resume
Duties:
Tech Services / Product Development:
With guidance : Write and execute equipment and process qualification protocols and summary reports /
Write batch records / Write change controls / Write SOP’s / Perform Basic root cause analysis & design of experiment.
Hands on Testing:
Perform and summarize all physical analysis related to new product development including Sieve Analysis, Camsizer, SEM, VTI, Texture Analyzer, Viscosity, pH, and Density.
Responsibilities:
Responsible for collecting, coordinating, organizing, summarizing and entering all new product development and characterization data. This will include individual sample tracking and the graphing of all data needed to assess a formulation or process. This database must be kept current to allow effective decision making and planning. Report to Manager R&D.
Qualifications:
1-2 years of experience in related industry / job a plus
Minimum of a Bachelors degree in a technical field or equivalent experience.
Proficiency in use of software including Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft;
Visio (Process Flow Diagrams a plus);
Statistics / Minitab a plus;
Good communication and writing skills.
Personal Characteristics:
High energy / Can-do attitude (Optimist) / Hard Working / Driven for results
Curious / Ability to multi-task / Sense of humor/ High self-expectations / Efficient
Elite Pharmaceuticals is located at 165 Ludlow Ave., Northvale, NJ (Bergen County) 07647
We offer a competitive salary and benefits package.
Send resume with salary requirements to careers (at) elitepharma.com
No agencies please.
Job Type: Full-time
Required experience:
experience in related industry/job a plus: 1 year
Required education:
Bachelor's
Indeed - 8 hours ago
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I respect much of the insight that you provide on this board but your comment here is a far cry from any sort of realistic justification. The milestone payments have a contractual end in the very near future. They do not signify any increase to do the organic revenue generated by the company and should be ignored in any forward-looking stock price evaluation.
I need to revisit the last Q, but annualizing the $5M in Epic fees is not sound analytics as that isn't expected every quarter in perpetuity. I thought they had to revise financials due to not booking it correctly over time as it is earned over life of the Epic contract, which makes the extra $5M way overstated for one quarter.
I think Jerry screwed something up that was under his direction. My guess is lack of execution. I worry about timing as if it was something related to ELI-200 submission.
One cannot tout the agreement without reading the language. We have no idea on what was "agreed".
We can argue DCF assumptions till the cows come home. Not worth anyone's time.
Plan A is getting ELI-200 approved and generating revenue to prevent dilution to support future R&D. If ELI-200 is stalled from being out on the market that is a disastrous consequence, but is realistic that no one is talking about. It could delay real revenues being generated for about 1.5 - 2 years.
Hype drives biotech stocks in early stages whereas now it is up to Elite to put up or shut up and prove results. Future pipeline is heavily discounted in DCF analyses as there are required studies and time doesn't work in our favor. $10 is an unrealistic dream.
I am with you, but Elite 15 years ago & Elite today are not apples to apples. The outstanding shares are multi-fold of what they were back then. I think directionally you are right, but realistically over aggressive with optimism. Would love to see it though.
Great dialogue. I don't think Elite will escape legal proceedings. I have confidence that the FDA will approve with additional minimal studies. I am more interested in how Elite is strategizing if ELI-200 CAN'T go to market next year due to legal woes. I see this as inevitable. Generics cover op expenses, but not R&D. Shares could always be sold, but hopefully not the route taken. If FDA does approve ELI-200, I think some realistic partnerships with big pharma will present themselves to further the required studies of the pipeline. Not our plan A, but an option of which I think there is high liklihood.
Not to be a smarta**, but revenue does run through the balance sheet - Revs & expenses run through equity account.
The shares outstanding aren't apples to apples. JAZZ Had about 6 times less shares outstanding at that point than Elite does today. In my oponion a rise that meteoric is out of the question.
Were you the last caller in yesterday's cc? Profit is not the driver for the volitility.
$2.7M. Strong increase over LY. Going to be good call tomorrow. Enjoy!
Auditors still review for compliance, but just do a full audit. They also do intra period audits throughout the year on processes & controls, but auditors review all financials prior to being filed with the SEC. This shouldn't be a surprise to anyone.
I think after market close is my guess.
Auditors have to sign off prior to the 10Q release. I am sure it was wrapped up early to mid last week to allow time to analyze & prep associated commentary.
Have you seen typical splits? I would be interested in hearing you actually do some research on this. 50% split is far from realistic as well.
*revenue
Aren't they in a recenue share agreement with Epic for Eli-200? I can't imagine their share would be anywhere near your topline figure. I see Elite being the manufacturer for some products, but not developing a sales staff to reap all topline benefits.
Based on market cap. I worked for a company that became an accelerated filer. Market cap was determining factor.
The only reason for the record figure last Q was due to the $5M payment from Epic. It was not driven from ongoing operations. It does, however, buy a little more time as Elite will get another similar payment during this quarter for NDA submission. I am not expecting anything fabulous this quarter, but am much more interested in the bigger picture of what is to come beyond ELI-200 during 2016. An earlier submission than end of year would be good news, but not counting on it.
In recent investor conference the CEO stated that top line results are "hopefully" going to be released in October. I read this as last few days in October or early November.
Webcasts are typically for presentations, not video of the speaker. I'd expect potentially scientific education, pipeline update on timing, business strategy update & selling us on the future potential of what is to come.
I just left a position where I managed a $100 million/year capital budgeting program. Not all intangible assets are amortized. If it has a definite useful life it would be; however, there are some intangible assets (e.g., brand related) that will forever remain on the books and are not amortized.
I know what a CTO is, but you haven't said whether it would exclude any communication from the FDA. That's what I'm looking for as to whether there is anything they could potentially hide in relation to the FDA to prolong communicating it to the public a little while longer until another study has been completed.
My first impression is that the FDA is that there were issues with one of the studies, but I wouldn't think they could use a CTO for that. Thoughts?
"Development of our abuse-deterrent opioid technology continues to be Elite's top priority and we invested $4.0 million this quarter for a human abuse liability study, bioequivalence studies, and other product development activities. Elite remains on track to file its first abuse-deterrent opioid product, ELI-200, by the end of calendar 2014."
Just curious but how is the delay not Elite's fault? The above statement was from a prior cc. They were "on track" about 6 months ago. The trial would have been completed by now had they actually been conservative with their assumptions. They took on huge risk of assuming the FDA wouldn't need one and realism brings to light that a PIII would be required. What was the risk? Losing out on a year of revenue in a multi-billion dollar market. Pure incompetence. Shame on the other senior team members or Board for not doing their job. Always better to over than under prepare.