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I beg to differ... I'm a Long who adds to my ELTP position whenever the PPS dips. The paltry profits that Shorts may make will pale in comparison to the huge profits the Longs such as myself will reap when ELTP brings its ADT products to market.
"...However, abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible..."
Thanks for posting yet another article on a competitor's Hysingla ER's abuse deterrent technology that is inferior to ELTP's. Just more examples of ELTP's ADT technology being far better than the rest.
"Targiniq ER can still be abused, including when taken orally (by mouth), which is currently the most common way oxycodone is abused."
Thanks for posting an article about a competitor whose Targiniq's abuse deterrent technology is inferior to ELTP's. This just reinforces that ELTP's ADT technology is better than the rest.
Nasrat has indicated for sometime now his desire to partner with another company for marketing support. Nasrat is also looking for a manufacturing partner to produce the drugs over and above the 4-5 he feels ELTP can handle itself.
Sounds like there was an October meeting with the FDA:
Good morning. Just a couple of questions... On the FDA meeting that was held was this the first meeting with them, at our last conference call there was a forecast that it would occur in October?
Nasrat Hakim - President and CEO
That is correct. There are two types of meeting we hold with FDA. There are answer and question meetings where they commit to give you a question within a certain time if you don’t meet with them in person and there is the face to face. In October they gave us responses in writing in November and they agreed to the date on the 17th which was the one where we were face to face. So both of them did take place each one is at a different floor.
Unidentified Analyst
**** Elite Pharmaceuticals Conference Call Questions ****
Shareholders participating in the Conference Call Q&A session are typically allowed to ask one question following opening statements. To make the most of this Q&A opportunity with ELTP management, suggest that we come up with a list to share of top questions to ask:
(Copy/paste the latest posted list and add your question(s) at the end of the list)
1. Clinical Trials
a. When can we expect Lifetree abuse liability results?
b. How long do you expect these trials to last?
c. How many products are tested at a time in these studies?
d. Is the plan to file upon successful results?
2. Lincoln Park Capital (LPC) Securities Funding
a. How many have been placed with LPC exclusive of the free shares?
b. How much money was generated for the shares?
c. How much of the money has been spent?
d. What was it used on?
3. Any plans for Eli-154?
4. Updates on Eli-201 and Eli 202?
5. What's going on with the three drugs in Scale up?
6. Any generics moving up the ladder to commercialization?
7. Given the share price hovering at the “worst case” scenario, and far below the 2.10-2.75 levels that were indicated
as the more reasonable valuation range at that time, why are you comfortable with the valuation as reflective of Elite’s future?
8. I understand we had an agreement with Epic for 8 drugs where we get a 15% profit split. I also understand that we are no longer proceeding
with the last 7 drugs. However, the first and only drug has been filed with the FDA for 3 1/2 years now and we haven't heard anything. Do you have any updates on this?
9. Was there a pre-NDA meeting held in October with the FDA as forecasted at the last Conference Call... Or was November 17th the first FDA meeting?
10. Any updates/details on the Hong Kong based company/partner that is to develop a branded product for the United States market and its territories?
11. Status update on the arbitration of Phentermine with Precision Dose?
12. Given that Elite's generic NDA ART line takes less time and money to bring to market then Elite's once daily Eli 216 product can you speak to what the current plans are for this product say for instance to partner a combo Eli 201 and 216 together and how quickly you are planning to move forward with this product as there is no other once daily abuse resistant product on the market?
**** Elite Pharmaceuticals Conference Call Questions ****
Shareholders participating in the Conference Call Q&A session are typically allowed to ask one question following opening statements. To make the most of this Q&A opportunity with ELTP management, suggest that we come up with a list to share of top questions to ask:
(Copy/paste the latest posted list and add your question(s) at the end of the list)
1. Clinical Trials
a. When can we expect Lifetree abuse liability results?
b. How long do you expect these trials to last?
c. How many products are tested at a time in these studies?
d. Is the plan to file upon successful results?
2. Lincoln Park Capital (LPC) Securities Funding
a. How many have been placed with LPC exclusive of the free shares?
b. How much money was generated for the shares?
c. How much of the money has been spent?
d. What was it used on?
3. Any plans for Eli-154?
4. Updates on Eli-201 and Eli 202?
5. What's going on with the three drugs in Scale up?
6. Any generics moving up the ladder to commercialization?
7. Given the share price hovering at the “worst case” scenario, and far below the 2.10-2.75 levels that were indicated
as the more reasonable valuation range at that time, why are you comfortable with the valuation as reflective of Elite’s future?
8. I understand we had an agreement with Epic for 8 drugs where we get a 15% profit split. I also understand that we are no longer proceeding
with the last 7 drugs. However, the first and only drug has been filed with the FDA for 3 1/2 years now and we haven't heard anything. Do you have any updates on this?
9. Was there a pre-NDA meeting held in October with the FDA as forecasted at the last Conference Call... Or was November 17th the first FDA meeting?
10. Any updates/details on the Hong Kong based company/partner that is to develop a branded product for the United States market and its territories?
11. Status update on the arbitration of Phentermine with Precision Dose?
**** Elite Pharmaceuticals Conference Call Questions ****
Shareholders participating in the Conference Call Q&A session are typically allowed to ask one question following the company's opening statements. To make the most of this Q&A opportunity with ELTP management, suggest that we come up with a list to share of top questions to ask:
(Copy/paste and add your question(s) at the end of the latest posted list)
1. Clinical Trials
a. When can we expect Lifetree abuse liability results?
b. How long do you expect these trials to last?
c. How many products are tested at a time in these studies?
d. Is the plan to file upon successful results?
2. Lincoln Park Capital (LPC) Securities Funding
a. How many have been placed with LPC exclusive of the free shares?
b. How much money was generated for the shares?
c. How much of the money has been spent?
d. What was it used on?
3. Any plans for Eli-154?
4. What's the next step for Eli-201?
5. What's going on with the three drugs in Scale up?
6. Any generics moving up the ladder to commercialization?
7. Given the share price hovering at the “worst case” scenario, and far below the 2.10-2.75 levels that were indicated
as the more reasonable valuation range at that time, why are you comfortable with the valuation as reflective of Elite’s future?
8. What is ELTP expecting from the FDA by filing the INDs for ELI-200 and ELI-202?
9. I understand we had an agreement with Epic for 8 drugs where we get a 15% profit split. I also understand that we are no longer proceeding
with the last 7 drugs. However, the first and only drug has been filed with the FDA for 3 1/2 years now and we haven't heard anything. Do you have any updates on this?
Fellow ELTP Investors,
Now that ELTP's 2nd Quarter Financials have been filed, I'd like to facilitate the collection of shareholder questions for next Wednesday's Conference Call Q&A session with ELTP management. For those who have not participated in the Q&A session before, I'll repeat the purpose/intent of putting together a question list. The callers who participate in the Q&A session are typically limited to asking one question. We’ve got some very knowledgeable ELTP shareholders here on IHub who are well versed in the pharmaceutical arena and have the expertise to provide excellent questions. But they may not be able to participate in the Conference Call or, if they do partake, will only be allotted one question to ask. That’s where the less knowledgeable of us, such as myself, come in… By referring to the Conference Call Question List, we can collectively get most, if not all, of the questions asked.
I will kickoff the Q&A list off with leftover questions from the August Conference Call that were either not asked or are still relevant for updates. Please note that my role is NOT to censor or editorialize submitted questions. If you have an opinion about what should or should not be asked at the Q&A, then please voice it via a public post on this board. Of course, it's ultimately each callers' prerogative as to what they choose to ask with their allotted question.
With that being said, the Conference Call Question list will follow in a subsequent post.
MJ
Spot on speculation from our resident iHub ELTP gurus regarding the reason for the delay until Wednesday for the Conference Call:
Nasrat Hakim:
"...We, of course, also continue to diligently pursue development of our abuse-deterrent products, and we have an FDA meeting regarding ELI-200 on November 17th. I look forward to providing an update on this meeting for you during our conference call on the 19th. ELI-200 is expected to be the first abuse-deterrent product filed with the FDA by Elite.”
nokoolaid,
First let me say that I have found your posts to be among the most intelligent, informative and well written on this board.
I have facilitated the collection of questions for the Annual Shareholders Meeting, as well as, the last couple of Conference Calls. I only provided an advance copy of the question list to ELTP's Investors Relations, Diane Will, for the Annual Shareholder's Meeting... There were no advance question lists provided to Diane for the subsequent Conference Calls since there were some opposing posters on this Board for doing so out of concern that it would only result in prepared canned answers.
Regarding LPC, the following had been submitted to the question list for the August Conference Call question/answer session:
6. Lincoln Park Capital (LPC) Securities Funding
a. How many have been placed with LPC exclusive of the free shares?
b. How much money was generated for the shares?
c. How much of the money has been spent?
d. What was it used on?
Unfortunately, the only LPC related question that was asked by a caller at the August Conference Call was more pointed to ELTP's share price:
"Question: I don’t think there was a big surprise why the price of the stock is suppressed. I think the vote for the new shares is one of the biggest reasons and I wanted to ask about that. I think there was a big concern among investors about the increased number of shares and I also wanted to ask what is happening with the possible uplifting at the stock."
Once ELTP's 2nd Quarter Financials are filed, I'm be more than happy to facilitate a question list for next week's Conference Call. I not only encourage everyone to submit their input, but also to participate in the Conference Call question/answer session so that most, if not all, questions get asked/answered.
MJ
Hardly an ELTP competitor when the FDA's approval bears this caveat:
"... The approval carries the limitation that because of the risk for addiction, abuse, misuse, overdose, and death with opioids, even at recommended doses..."
According to the banner message at the top of the iHub webpage:
ADVFN is working with their provider to get L2 quotes up ASAP
The iHub ticker is not a real time quote. As of 9:51AM, the last price is $.320 on 46,548 volume.
One would think most folks would understand the difference between Outstanding Shares and Authorized Shares.
Form 4 - Statement of Changes in Beneficial Ownership filed
ELTP CEO Nasrat Hakim's closing remark:
"This has been our year... Next year will be even better!"
[...expanded facility, new qualified hires, new production equipment...]
Here's what Doug Plassche - Executive Vice President-Operations had to say about the expanded facility, hires and equipment at the last CC:
Good morning. It was just, I think, six weeks ago so I will be fairly brief. On the commercial front, we have put a lot of our work in systems and execution into good use, resulting in a slight reduction in headcount despite volume being up. We’ve eliminated approximately 15% of the commercial headcount. We continue to focus on upgrading equipment in both laboratory and manufacturing and continue to grow with each new product that arrives.
On the R&D front, we’ve been extremely active with the manufacturer of a number of submission batches. We hired additional technicians and technical service engineers to help with the processing of all the data to support the filings and we are starting to really see the benefit of those hires.
Capacity, we recognized will become a constraint, as we approach commercialization of the first ART product. To that end, we leased an additional 20,000 square feet in the current commercial manufacturing building and completely refurbished approximately 2,000 square feet of it for our QA Department to be centrally located.
The remainder of the space is open warehouse, which provides easy fast low cost internal construction for manufacturing. As a parallel activity, we are developing scope and bid documents for commercial scale manufacturing equipment, as well as evaluating existing commercial sites. To date these have been out of the state. However, we will consider any site that suites our needs.
Overall, I think, we’re doing the right things on multiple fronts both tactically and strategically, and the quality and the cohesiveness of the team continues to improve resulting in much needed efficiency and momentum.
Where's the October meeting with FDA????
Don't forget about the meeting with the FDA in October...
Down 7/1000 of a penny doesn't seem like much to me....
Nasrat's response from the CC on ELTP's shareprice:
Question:
I know people are thinking about this. So I’m going to ask and I don’t know how could even answer it, but can you tell me why the stock is just so flat but all it is positive news?
Answer:
Nasrat Hakim
If I had the crystal ball I would. Honestly I can’t even begin to guess. Elite has had a turbulent history and that affected us a little and there aren’t a lot of negative news, some bashers here and there. But overall, if you step back and look at our achievement, especially in the last year it’s mind-boggling. And you can suppress things like this for a little while, but you cannot once there is a product that’s been submitted to FDA, you cannot – once the product that’s been approved by FDA, once hopefully we either come up with a partner or financing. So we continue with this. So the next few months are going to be really telling and I feel, this is my personal feeling, that this is going to change and over the next year, especially with an approval from FDA and a long stay of hopefully next September, nobody is going to be able to stop us.
According to ELTP's CFO, Carter Ward, the company's financials have "never been stronger":
Carter J. Ward
Thank you, Nasrat, and thanks everyone for calling in today. Last Friday, we filed our 10-Q for the quarter ended June 30, 2014. We’re on a March fiscal year. So the June quarter is the first quarter of our 2015 fiscal year.
Nasrat commented last week that we had a strong start to our fiscal year and I think that pretty well summarizes the overall financial results and position for our first quarter of fiscal 2015.
Financials are available online at elitepharma.com, as well as sec.gov and all the usual other sites like Google, Yahoo!, MSN Money and OTC Markets. You had the weekend, so hopefully most of you have had a chance to review our financials.
I’d like to spend a few minutes going over some of the more important aspects of our financials. So when going through our financials, I’m going to start first with something that is not our balance sheet anymore and that would be the $3.3 million asset relating to our investment in Novel Laboratories. This investment is dating back to 2006.
During this quarter we sold our minority stake in Novel for $5 million and we recognized $1.6 million gain. $5 million in proceeds received was used to get us current on our bonds, which I’ll discuss later and also to help fund the ongoing trials and development of our abuse-deterrent opioid products.
The takeaway on the Novel transaction is that for the last seven plus years we had an asset that wasn’t contributing or supporting our core objectives and operations. During this quarter, we monetize that asset and we are now able to use those resources to support our corporate objectives. That’s a strong start to our fiscal year for sure.
Also no longer existing and relating to our balance sheet is the longstanding monetary defaults on our New Jersey Economic Development bonds. This monetary default reflects more than five years, and as of July 23 has been accrued. We’ve paid all principal and interest amounts which were in arrears, an amount of just less than $1 million.
We retired the Series B bonds, which carried 9% interest rate and we are now current on our Series A bonds. So we cheered a long standing monitory default, and solidified our balance sheet, we now have sufficient working capital on hand to fund the ongoing product development activities. Once again another example of a strong start to our year.
With that I’ll move on to the P&L statement. Revenues for the quarter were $1.2 million that’s a 60% increase on a year-on-year basis. Now the reason for this increase is pretty straight forward, all our products which are relatively new, ranging from less than a year to just over three years in the market. They’ve all grown as expected, the growth at this time was expected and the sales of our Phentermine, Hydromorphone, Methadone and Phendimetrazine are growing nicely. In addition, we launched Generic Naltrexone last September, so that product generate revenues during this year’s June quarter, but not in the June 2013 quarter.
So our commercial generic products are performing nicely. Let me also remind you there are twelve additional products which were acquired last year, which are being transferred for manufacturing either at Elite or at locations licensed by Elite. This in progress and this will provide an even greater and broader revenue base, which we expect will generate new and growing revenues. Yet again another example of a strong start to our year. We increasing revenues and we have a pipeline of additional products on the horizon for the future.
So moving down to P&L statement, into the operating expense section, by far, the most relevant number there is our research and development expense. Last year’s June quarter was the last full quarter before Nasrat Hakim joined us to Elite. From day one, Nasrat emphasized the urgency of commercializing the products using our abuse-deterrent technology. And this focus is clearly seen in R&D expense line items on our P&L statement.
R&D expenses for the June quarter of this year were just over $4 million, as compared to less than $600,000 last year. This is an increase of almost $3.5 million or more than 600%, that’s a big change from last year. Nasrat will talk about product development activities in more detail. And I just wanted to say that, as of today we’ve already conducted several successful studies, we have ongoing studies and trials for multiple abuse-deterrent opioid products, and we’re on schedule for filing of our first of these products by the end of 2014 itself. None of that existed last year. That’s why R&D expenses have increased.
From a finance perspective, we’re prepared and able to fund these costs. Our generic revenues are growing and they are contributing. We monetized our investment in Novel. We have the Lincoln Park equity line supporting us well. So, financing of the planned studies and the R&D activities is accordingly in place and available. I’ve also mentioned in the past the importance of putting working capital to use and this is exactly what I mean. We’re putting our working capital to very good use.
So to summarize, it has been certainly a strong start to our fiscal year. Revenues are up, product development continues to accelerate, we’re on track for our first opioid filing this year, and financially Elite has never been stronger. So there’s a lot to be encouraged about.
Here's Nasrat's take on ELI-200 from the CC:
Nasrat Hakim
Thank you, Doug. Good morning again ladies and gentlemen. Over the weekend, I actually wrote a little presentation to go through with you, of all of our achievements in the past years since I have been the CEO. This morning I threw them to the trash, I decided not to do that. What I want to do this morning is walk you through our flagship product, ELI-200. And in precise again, many of the things that I’ve said to you before, because a lot of questions are coming to them that people have not understood the steps we have to go through to get this product to the market.
We have a lot of other products in clinical trial and lot of other activities. And I’m sure you’re going to ask about that when doing Q&A. So let me focus on ELI-200, because that is truly the most exiting right now. And I’ll walk you through beginning to end one more time what we’re doing. In order to launch a product, especially an anti-abuse product, NDA, you have to have a robust successful formulation. That requires a lot of work, reproducibility and long-term stability on accelerated temperature. We have that and that was very successful.
The second thing that requires bioequivalence trial, you got to compare your product to a comparator that the FDA knows often has tested before, have tested the product before. That was very successful and we’ve done that as well, that was the trials that we went through in January of 2014. After that, you have to comply with the FDA’s guidance on anti-abuse. That spells out the three categories for the industry to go through. You don’t have to comply with all of them. You have to comply with what you need to have on your labeling.
The first category is the lab in vitro anti-abuse. That is very exciting work, as a matter of fact, we created an entire department to handle this work at home, meaning at Elite. We hired a consultant with Ph.D. that’s managing the project, we hired a manager, scientist with an M.S. and many, many years of relevant experience in the industry, another scientist with masters in pharmacy and an M.S. will be finished in December and two summer interns, just to handle this kind of work. The late anti-abuse work is very intricate.
We were talking about trying to mimic what a person who wants to abuse your product to do at home. So you have on a lot of alcohol trials assuming people have alcohol at their house, acetone because it is used for nail polish all the way to juices and Coca-Cola. Very important work that has taken us at least seven month and we will be done with that in September and we will announce that works for you late September, early October and it will be ready for us deliver to the FDA.
The second two categories are the human abuse liability trials. Again, these are long-term extended trials from the time we started writing protocols till we will have data. It will probably take between seven and nine months. These are clinical trials where people will actually take our product.
When it’s intact and they take it when it’s crushed and they have to report back, the crushed felt like a placebo otherwise the experimental network. They cost millions of dollars and they are handled by a Canadian entity that had to have the approval of the Canadian Government as well as the FDA.
Again, the results hopefully will be done sometime toward the end of September, we’ll have a preliminary number. We will issue a final report somewhere around October. So the human in vitro studies and the in vitro studies will be ready before October. Why I am giving you these dates, because I am pushing this back on all the consultants to have them ready before we go to the FDA, pre-NDA meeting in October.
I need them to evaluate these and tell us if there is anything missing, so we can take care of it before the filing date of December 2014. The FDA asked for a pediatric study, which we have communicated to them that we’d like to do it sometime next year, was the application spending, and we have no doubt that they’ll accept, they’ll respect and that they will accept such a request.
In October, once we meet with the FDA, we’ll have them give us an assessment of the adequacy of all the data generated. Now we all interpret the regulations. We believe this is what we need to do, and then the FDA will tell you if you’ve gone to their standards or to their base or not. So we will have a lot of feedback hopefully after October from the FDA.
Again, my vision is and has been for the past year and I’ll update the view on this with every single meeting. And it was the full order of my stat to deliver a filing by December of this year, and we are on target to do that. The only thing that could delay us, as I said before, no one can stop us. Elite’s anti-abuse is coming to the market. The only entity that could delay it is if the FDA requested one more clinical trial, which will put us on lab out six months. We will know about that once we meet them in October.
Next step, what are we thinking about once we file. We believe the FDA will brand us, expedite the review and we’ll give us results probably by – or approval by September of 2015. That will be the date where we’d be launching and about a year from now, August, September of 2015. To do so we have to decide what we’re doing our product. I have made the decision we will be manufacturing ELI-200 ourselves.
I have had several companies that approached me and asked if contract manufacture for us, they have much bigger facilities and I’ve decided the product is staying with us. The marketing of the product, we have several options. We either contract the sales and marketing force, and Chris and I have been in contact with such entities and that proposals and numbers and what have you.
And the second is to have a well-established pharmaceutical company that has the capabilities and sales and marketing force of 150 to 200 people that can sell our product in addition to this at some kind of a profit sharing or commission. I have not made the decision on that part and that will have to be made by December once we file, okay.
This is the status of the ELI-200. It is the most exciting product we have right now. We are filing an application, which have never happened in the history of this company. We’re launching an awesome product. I mean this is exceptionally exciting.
We have several other products in development that we’ve updated to you on. We’ll start with the clinical trials for ELI-201, same thing with ELI-202. Again, the results and data will be available in October probably. We filed INDs for all of them. We’re in communication with FDA on what is required and all of that part is exciting, but the filing will take place in December of this year for ELI-200 and that really is our flagship.
ELTP is learning from the FDA approval process for ELI-200. They will be able to anticipate what the FDA wants for future submissions that follow.
CC Question:
You really emphasized ELI-200 and it seems obvious that you’re receiving FDA guidance on what needs to be done to get this product to market by end of the year. If it’s successful if all the tests are successful, which so far they are and everything goes as planned FDA receives it’s submission and ultimately grants the product to be produced, does that make the follow-up products that much easier as far as the processes, I mean, like ELI-201, ELI-202, can it be streamlined a little with modifications, relating specifically to that type of product? But does it make the testing process that much easier because it’s been already approved in ELI-200 and since the Elite’s tech is modular, does the FDA give a more of the streamlined on the follow-up products?
Answer:
Nasrat Hakim - President and Chief Executive Officer
Absolutely, okay, that is very true. It’s from the FDA standpoint than ours. A lot of this, I mean the guidance on the anti-abuse is recent so it was uncharted waters to a large extent. Once we have gone through it thoroughly with the FDA on ELI-200, then we can already anticipate what the FDA wants. For example, in vitro studies, or in the human anti-abuse studies, we can anticipate that and go ahead and be proactive and run all of these studies instead of submitting a petition to FDA and waiting to see if it’s okay. You are correct it will help a lot to expedite things in the future and possibly it could have a little bit of savings associated with it because we can bump a couple of things at the same time.
Nasrat dispels rumors that he's employed on a 3 year contract with ELTP:
Question:
Nasrat, my question is, I know you signed on for a three-year contract. Are you looking to stay on longer?
Answer:
Nasrat Hakim - President and Chief Executive Officer
I’m not sure who started that rumor, but I've heard it before. So I went ahead and looked at my contract and it doesn't say three years anywhere in it. So, I’m here as long as Elite needs me and as long as I’m having fun and bringing stockholder value. Since I've taken over a year ago the stock has increased by about 400%, 500%. We’re introducing new product to the market. As long as good stuff is happening I’m here. If a huge company end up paying the right price for Elite, I’m very open-minded. And they buy us tomorrow, I retire tomorrow. So definitely I could be here for the next five, 10 years and well that’s not going to happen tomorrow, but I could be out sooner than three years.
Nasrat responds to the naysayers of the LPC deal in CC:
Question: I don’t think there was a big surprise why the price of the stock is suppressed. I think the vote for the new shares is one of the biggest reasons and I wanted to ask about that. I think there was a big concern among investors about the increased number of shares and I also wanted to ask what is happening with the possible uplifting at the stock.
Answer: Nasrat Hakim
Okay. The uplifting of the stock on the NASDAQ is one of the things that I don’t mind, and, again preliminary, I see us there in 2016. I have always said this from day one, I do believe in fundamentals. I need to see our company have solid fundamentals, earnings and revenues, which determines the price of the stock and I do not want to rush to any stock exchange and have us crash back into a penny stock. Okay. So it’s not going to happen until we file a product, get an approval and start generating revenue. I want us there for good period. And hopefully it will happen organically and the financials will support it.
As to the number of shares, and I’ve heard what you said from other callers and from few people. Maybe it is, but the fact is whenever you are a small company like us, which have an exceptional product and you don’t have money to take it all the way, you have to bring in some kind of a financing. The Lincoln Park deal has been one of the best things that this company has ever done.
Here is my analogy of why I think that is excellent. (indiscernible) on this beautiful house that’s sitting on a great mansion, but it doesn’t have a roof, and you know that if you do not invest the money in building the roof, rain is going to destroy it, okay. Bring in a 10th person who will take 10% of that in pi or pie, if you will, will be the best way for you to protect the house and have a roof on top of it and have an asset that’s valuable.
Elite was exactly like that. We had the technology that we could not take anyway, because we don’t have money and without the deal with Novel and without the deal with Lincoln Park, the company would not have increased 500% in share even though we added more share and the company would not be able to get an approval for the first half product. Yes, it is a traded, but I think it’s more than a fair one.
Nasrat Hakim:
ELI-200 is ELTP's "flagship" and "most exciting". Expects to deliver filing by December 2014. The only cause for delay would be if the FDA requires further testing.
The expansion of the Northvale facilities provides the ability to manufacture and distribute some of the ART drugs without a partner. But not all of the ART products.
**** Elite Pharmaceuticals Conference Call Questions ****
Shareholders participating in the Conference Call are typically allowed to ask 1 or 2 questions following the company's prepared statements.
To make the most of this Q&A opportunity with ELTP management, suggest that we come up with a list to share of top questions to ask:
(Copy/paste and add your question(s) at the end of the latest posted list)
1. Clinical Trials
a. When can we expect Lifetree abuse liability results?
b. How long do you expect these trials to last?
c. How many products are tested at a time in these studies?
d. Is the plan to file upon successful results?
2. Please explain the purpose for the upcoming meeting in October with the FDA. Best case and worst case scenario.
3. With so much going on will Analyst be reassess-updating last Falls value of Elite for future negotiations?
6. Lincoln Park Capital (LPC) Securities Funding
a. How many have been placed with LPC exclusive of the free shares?
b. How much money was generated for the shares?
c. How much of the money has been spent?
d. What was it used on?
7. 2 FDA applications ... what info can we get? How long have they been in the system?
8. 11 ANDA's for site transfer, what's going on?
9. Any plans for Eli-154?
10. What's the next step for Eli-201?
11. What's going on with the three drugs in Scale up?
12. Any generics moving up the ladder to commercialization?
13. Given the share price hovering at the “worst case” scenario, and far below the 2.10-2.75 levels that were indicated
as the more reasonable valuation range at that time, why are you comfortable with the valuation as reflective of Elite’s future?
14. In July, the FDA approved Purdue's Targiniq ER with labeling describing the product's abuse-deterrent properties. Is ELTP's ART more effective than Purdue's? If so, is it likely that the FDA will also approve ELTP's ART products?
15. What is ELTP expecting from the FDA by filing the INDs for ELI-200 and ELI-202?
16. Given the information in the 10-Q regarding the expansion of the Northvale facilities... Does this mean ELTP could potentially manufacture and distribute all of the ART drugs without a partner?
17. I understand we had an agreement with Epic for 8 drugs where we get a 15% profit split. I also understand that we are no longer proceeding with the last 7 drugs. However, the first and only drug has been filed with the FDA for 3 1/2 years now and we haven't heard anything. Do you have any updates on this?
**** Elite Pharmaceuticals Conference Call Questions ****
Shareholders participating in the Conference Call are typically allowed to ask 1 or 2 questions following the company's prepared statements.
To make the most of this Q&A opportunity with ELTP management, suggest that we come up with a list to share of top questions to ask:
(Copy/paste and add your question(s) at the end of the latest posted list)
1. Clinical Trials
a. When can we expect Lifetree abuse liability results?
b. How long do you expect these trials to last?
c. How many products are tested at a time in these studies?
d. Is the plan to file upon successful results?
2. Please explain the purpose for the upcoming meeting in October with the FDA. Best case and worst case scenario.
3. With so much going on will Analyst be reassess-updating last Falls value of Elite for future negotiations?
6. Lincoln Park Capital (LPC) Securities Funding
a. How many have been placed with LPC exclusive of the free shares?
b. How much money was generated for the shares?
c. How much of the money has been spent?
d. What was it used on?
7. 2 FDA applications ... what info can we get? How long have they been in the system?
8. 11 ANDA's for site transfer, what's going on?
9. Any plans for Eli-154?
10. What's the next step for Eli-201?
11. What's going on with the three drugs in Scale up?
12. Any generics moving up the ladder to commercialization?
13. Given the share price hovering at the “worst case” scenario, and far below the 2.10-2.75 levels that were indicated
as the more reasonable valuation range at that time, why are you comfortable with the valuation as reflective of Elite’s future?
14. In July, the FDA approved Purdue's Targiniq ER with labeling describing the product's abuse-deterrent properties. Is ELTP's ART more effective than Purdue's? If so, is it likely that the FDA will also approve ELTP's ART products?
15. What is ELTP expecting from the FDA by filing the INDs for ELI-200 and ELI-202?
16. Given the information in the 10-Q regarding the expansion of the Northvale facilities... Does this mean ELTP could potentially manufacture and distribute all of the ART drugs without a partner?
**** Elite Pharmaceuticals Conference Call Questions ****
Shareholders participating in the Conference Call are typically allowed to ask 1 or 2 questions following the company's prepared statements.
To make the most of this Q&A opportunity with ELTP management, suggest that we come up with a list to share of top questions to ask:
(Copy/paste and add your question(s) at the end of the latest posted list)
1. Clinical Trials
a. When can we expect Lifetree abuse liability results?
b. How long do you expect these trials to last?
c. How many products are tested at a time in these studies?
d. Is the plan to file upon successful results?
2. Please explain the purpose for the upcoming meeting in October with the FDA. Best case and worst case scenario.
3. With so much going on will Analyst be reassess-updating last Falls value of Elite for future negotiations?
6. Lincoln Park Capital (LPC) Securities Funding
a. How many have been placed with LPC exclusive of the free shares?
b. How much money was generated for the shares?
c. How much of the money has been spent?
d. What was it used on?
7. 2 FDA applications ... what info can we get? How long have they been in the system?
8. 11 ANDA's for site transfer, what's going on?
9. Any plans for Eli-154?
10. What's the next step for Eli-201?
11. What's going on with the three drugs in Scale up?
12. Any generics moving up the ladder to commercialization?
13. Given the share price hovering at the “worst case” scenario, and far below the 2.10-2.75 levels that were indicated
as the more reasonable valuation range at that time, why are you comfortable with the valuation as reflective of Elite’s future?
14. In July, the FDA approved Purdue's Targiniq ER with labeling describing the product's abuse-deterrent properties. Is ELTP's ART more effective than Purdue's? If so, is it likely that the FDA will also approve ELTP's ART products?
15. What is ELTP expecting from the FDA by filing the INDs for ELI-200 and ELI-202?
And I wonder who is always Devil like?...
Question #14 was asked/answered at the Shareholder's meeting:
What is the name of the firm that completed the valuation and, given the events of the past three months, why are you confident the valuation remains accurate?
Nasrat would not reveal who performed the valuation. He stands by the valuation done and has nothing to hide. But wants to protect the valuation company from unnecessary phone calls/contact which might potentially jeopardize its relationship with ELTP.
**** Elite Pharmaceuticals Conference Call Questions ****
Shareholders participating in the Conference Call are typically allowed to ask 1 or 2 questions following the company's prepared statements.
To make the most of this Q&A opportunity with ELTP management, suggest that we come up with a list to share of top questions to ask:
(Copy/paste and add your question(s) at the end of the latest posted list)
1. Clinical Trials
a. When can we expect Lifetree abuse liability results?
b. How long do you expect these trials to last?
c. How many products are tested at a time in these studies?
d. Is the plan to file upon successful results?
2. Please explain the purpose for the upcoming meeting in October with the FDA. Best case and worst case scenario.
3. With so much going on will Analyst be reassess-updating last Falls value of Elite for future negotiations?
6. Lincoln Park Capital (LPC) Securities Funding
a. How many have been placed with LPC exclusive of the free shares?
b. How much money was generated for the shares?
c. How much of the money has been spent?
d. What was it used on?
7. 2 FDA applications ... what info can we get? How long have they been in the system?
8. 11 ANDA's for site transfer, what's going on?
9. Any plans for Eli-154?
10. What's the next step for Eli-201?
11. What's going on with the three drugs in Scale up?
12. Any generics moving up the ladder to commercialization?
13. Given the share price hovering at the “worst case” scenario, and far below the 2.10-2.75 levels that were indicated
as the more reasonable valuation range at that time, why are you comfortable with the valuation as reflective of Elite’s future?
13. In July, the FDA approved Purdue's Targiniq ER with labeling describing the product's abuse-deterrent properties. Is ELTP's ART more effective than Purdue's? If so, is it likely that the FDA will also approve ELTP's ART products?
I've been asked by several iHub folks to facilitate the Conference Call Question List again... For the ELTP newbies and those with selective amnesia, I'll repeat the origin and the purpose of the question list.
In past, I've been a "lightning rod" of sorts receiving feedback via PMs challenging the question list’s content, what should or should not be asked, etc. First of all, these aren't MY questions. I'm merely facilitating the collection of questions submitted by the iHub ELTP community.
I will start the list off with leftovers from the Annual Shareholder's meeting and the last Conference Call that were not asked or are still relevant for updates. My role is NOT to censor or editorialize what is submitted. If you have an opinion about what should or should not be asked at the Conference Call, then voice it via a public post on this board. Of course, it's each callers' prerogative as to what they choose to ask with their allotted time.
Which brings me to the purpose/intent for putting together the question list in the first place. For the benefit of those who have not participated in an ELTP Conference Call before, callers will first navigate a login menu where you will be asked if you want to participate in the Q&A session. I encourage everyone to do so since callers are typically given an opportunity to ask only a couple questions. We’ve got some pretty savvy ELTP investors here on IHub who are well versed in the pharmaceutical arena and have the expertise to provide excellent questions. But they may not have the opportunity to participate in the Conference Call or, if they do partake, will be allotted a couple questions to ask. That’s where the less knowledgeable of us, such as myself, come in… By referring to the Conference Call Question List, we can collectively get most, if not all, of the questions asked.
With that being said, the Conference Call Question list will follow in a subsequent post.
MJ
At the last CC, Nasrat Hakim said ELTP can get 5 products to market "easy" without a partner:
Thank you, gentlemen and thank you Hakim again. Just a quick question; how many ART products can ELTP get to market without a partner?
Nasrat Hakim - President and CEO
That's a very tough question because of the different ART products some of them you could make, you could get several with that and some you can only get two. The testing and requirements from FDA for each different ART is different and the more clinical trials you conduct, the more money you spend. So I would say for the money we have right now for the product you're selecting we probably can get five easy.
I had collected questions for the Annual Shareholder's meeting and sent them to Diane in advance of the meeting. However, since there was a set meeting agenda for the sole purpose of tallying votes, she wasn't sure if there was going to be a Q&A at the time. Not to mention, they were very busy preparing for the meeting. There were also opinions expressed here on iHub not to give the questions in advance. The logic being that prepared answers/responses would not be as potentially revealing as those candid, off-the cuff.
I also facilitated a question list for the last Conference Call. The idea being that since each caller is given an opportunity to ask one or two questions... Having a central list of questions available for all to reference would insure most, if not all, questions could get asked. I can do it again for the next Conference Call if there is an interest.
Businessweek.com
http://investing.businessweek.com/research/stocks/people/person.asp?personId=35746834&ticker=ELTP
Mr. Nasrat Hakim has been the Chief Executive Officer and President of Elite Pharmaceuticals, Inc. since August 1, 2013. Mr. Hakim has more than 30 years of pharmaceutical and medical industry experience in Quality Assurance, Analytical Research and Development, Technical Services and Regulatory Compliance. He has a proven management experience, in-depth knowledge of manufacturing systems, development knowledge in immediate and extended release formulations and extensive regulatory experience of GMP and FDA regulations. He served as a Vice President of Quality Compliance and Technical Services at Actavis LLC. Mr. Hakim served as Vice President of Quality of Alexza Pharmaceuticals Inc. since July 18, 2007. Mr. Hakim served as Corporate Vice President of Quality and Compliance for Actavis / Alpharma Inc., and previously served as Global Vice President of Compliance for Alpharma, where he was employed from 2004 to 2007. He has been a Director at Elite Pharmaceuticals, Inc since August 1, 2013. Mr. Hakim has also served as Executive Director of Corporate Compliance and Technical Projects for Watson Pharmaceuticals and Executive Director, Site Head of Quality and Compliance at TheraTech, Inc. Watson Pharmaceuticals acquired TheraTech in 1999. Mr. Hakim holds both a JD and BS in Law from Saratoga University in San Jose, California, a Masters degree (LLM) in Law from St. Thomas University in Miami, Florida and Bachelors and Masters degrees in Chemistry from California State University at Sacramento.
That's what I've done... I'm "all in" holding a hand as good as a royal flush with the cards E-L-I-T-E