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Tonight's 60 Minutes did a piece "A New Direction on Drugs" featuring top drug offical Michael Botticelli:
http://www.cbsnews.com/news/60-minutes-a-new-direction-on-drugs/
An excerpt:
"Michael Botticelli: We know one of the drivers of heroin has been the misuse of pain medication. If we're gonna deal with heroin and heroin use in the United States, we really have to focus on reducing the magnitude of the prescription drug use issue.
Many pain drugs are opioids, like heroin. And the number of opioid prescriptions has risen from 76 million in 1991 to 207 million today.
Michael Botticelli: We have a medical community that gets little training on pain, gets little training on addiction, and quite honestly has been promoting and continues to promote the overprescribing of these pain medications.
Couch,
Thanks for gathering all the DD into a top 10 list of ELTP's path to success. It's earned my Sticky!
MJ
Good to see you posting again, Dr. Pete!... I hope you have a speedy recovery and your arm gets back to 100%. Exciting times are ahead for ELTP.... You're going to need both arms to carry the bags of money coming from ELTP.
Your funniest words are ELTP pps dropping to 2 cents. LOL
Not to mention more misinformation when Johnny's predictions of ELTP's pps dropping to 2 cents never happens...
Nasrat quote from CC:
"We will make an announcement once we have received acceptance of the filing by FDA , which will most likely be the 1st or 2nd week of January..." "So we will file once we receive an acceptance from FDA. We will either issue a press release or have a conference call. Most likely we will issue a press release"
AJ's computations use fact-based metrics. Check it out:
http://investorshub.advfn.com/uimage/converted/635823148188180193.png
AJ's analysis has much more creditability than predictions made on this board about ELTP's shareprice dropping to 2 cents.
Or as Charlton Heston would say:
"I'll give you my ELTP shares when you pry them from my cold, dead hands"
Nasrat stated and I quote:
"We will make an announcement once we have received acceptance of the filing by FDA , which will most likely be the 1st or 2nd week of January..." "So we will file once we receive an acceptance from FDA. We will either issue a press release or have a conference call. Most likely we will issue a press release"
I was beginning to think that he wasn't going to ever ask a question.
Maz,
I think it would be difficult to reach a consensus assigning priorities in this forum given the board's number and variety of residents, not to mention the short time frame until he CC.
MJ
ELTP's 10-Q is out. Add your questions to the list for tomorrow's Conference Call:
**** Elite Pharmaceuticals Conference Call Questions ****
Those participating in ELTP’s Conference Call Q&A session are limited to asking one question following ELTP management’s opening statements. To make the most of this Q&A opportunity, 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. Any plans for ELI-154?
2. Now that the NDA filing is very near to completion, what are the status updates on ELI 201 and 202? Has the FDA given any indication (or have they been asked) about reduced trial requirements for ELI products that are similar to ELI 200? HAL studies and Phase 3s required for every single product?
3. Update on ELI-202 BE?
4. Any generics moving up the ladder to commercialization?
5. Elite had an agreement with Epic for 8 drugs where Elite gets a 15% profit split. Elite is 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?
6. Are there any numbers yet on the sales of Isradpin?
7. Status update on the arbitration of Phentermine with Precision Dose?
8. Given Elite's generic NDA ART line takes less time and money to bring to market than Elite's once daily Eli 216 product, what are the current plans for this product? How likely is it to partner a combo Eli 201 and 216 together? How quickly are you planning to move forward with this product since there is no other once daily abuse resistant product on the market?
9. What is the up to date information on the Public Float and Shares Outstanding for ELTP?
10. Given Nasrat's experience working at Alpharma and Actavis... Does he think Elite's patents are different enough from Purdue not to move toward legal avenues? If not, does Nasrat believe royalties fees would be the end result for Elite?
11. How does Elite's ADT compare to other ADT products that purport to detour swalling a handful of pills? What would it take to get Elite to attach "similar" ADT. How does Elite's microtablet technology improve on Elite's existing ADT? What is the microtablet technology worth once Elite begins to market its ADT opioids?
12. Did Epic ever settle with Purdue?
13. Does Epic have plans to ramp up sales and marketing departments in anticipation of marketing ELI-200 or future ART drugs?
14. What are the chances of an Epic and Elite merger? What would a reverse merger do to the PPS?
15. What's the current status of Mikah and the relation between Mikah/Epic as well as any possible conflict of interest that relation can cause to Elite?
16. Will there be a new valuation/assessment?
17. Will there be any Pie Charts to show shareholders the increase in shares?
18. We seem to have been "flying under the radar" for quite awhile now. Does Nasrat plan on presenting at more conferences (Rodman and Renshaw and others) to promote awareness and interest in the company now that we are in the last stretch for ELI 200?
19. Since EPIC is going to be marketing its own ER ADT OXY and Elite's IR ADT OXY at the same time, which ADT will Epic be using.....Will it be a hard turtle shell version like Purdue/Actavis has agreed upon.......OR is EPIC going to be using a version of Elite's ADT?
20. What are the scenarios/circumstances that would engage Elite to pursue up listing to the Nasdaq or anything comparable?
21. The annual shareholders meeting - Status update?
22. What is the rational/need for issuing additional shares to Lincoln Park in light of the revenue that will be gained from the recent licensing agreement with Epic? If the goal is to uplist to Nasdaq, doesn't the continued issuance of shares impede this goal?
23. Status update on the new fluid bed dryer.
24. Regarding EPIC's Oxycodone Generic. Is it strictly EPIC's ANDA product? Did Elite help to develop EPIC's Oxycodone?
25. Elite requested and was granted accelerated filer status by the SEC. Why did Elite want to be an accelerated filer?
26.
More ink:
http://www.wdrb.com/story/30469594/equities-lead-investor-sentiment-research-on-elite-pharmaceuticals-medical-marijuana-ekso-bionics-holdings-and-pharmacyte-biotech
Highlights from today’s reports include:
On Friday, November 06, 2015, the NASDAQ Composite ended at 5,147.12, up 0.38%, the Dow Jones Industrial Average edged 0.26% higher to finish the day at 17,910.33, and the S&P 500 closed at 2,099.20, down 0.03%.
- Elite Pharmaceuticals Inc’s stock edged higher by 6.14% to close Friday’s session at USD 0.42. The company’s shares oscillated between USD 0.37 and USD 0.42. The stock recorded a trading volume of 4.63 million shares, which was above its 50-day daily average volume of 1.48 million shares and above its 52-week average volume of 1.30 million shares. The stock is trading above its 50-day and 200-day moving averages of USD 0.25 and USD 0.23, respectively. Over the last three days, Elite Pharmaceuticals Inc’s shares have advanced 32.80%. Further, over the last three months, the stock has gained 78.57% and in the past six months, the shares have picked up 90.50%. On a compounded total return basis, the company has returned 46.64% in the past one week, and 92.66% in the past one month. Additionally, the company is trading at a price to earnings ratio of 10.48. This compares to a historical PE ratio of 6.42.
**** Elite Pharmaceuticals Conference Call Questions ****
Those participating in ELTP’s Conference Call Q&A session are limited to asking one question following ELTP management’s opening statements. To make the most of this Q&A opportunity, 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. Any plans for ELI-154?
2. Now that the NDA filing is very near to completion, what are the status updates on ELI 201 and 202? Has the FDA given any indication (or have they been asked) about reduced trial requirements for ELI products that are similar to ELI 200? HAL studies and Phase 3s required for every single product?
3. Update on ELI-202 BE?
4. Any generics moving up the ladder to commercialization?
5. Elite had an agreement with Epic for 8 drugs where Elite gets a 15% profit split. Elite is 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?
6. Are there any numbers yet on the sales of Isradpin?
7. Status update on the arbitration of Phentermine with Precision Dose?
8. Given Elite's generic NDA ART line takes less time and money to bring to market than Elite's once daily Eli 216 product, what are the current plans for this product? How likely is it to partner a combo Eli 201 and 216 together? How quickly are you planning to move forward with this product since there is no other once daily abuse resistant product on the market?
9. What is the up to date information on the Public Float and Shares Outstanding for ELTP?
10. Given Nasrat's experience working at Alpharma and Actavis... Does he think Elite's patents are different enough from Purdue not to move toward legal avenues? If not, does Nasrat believe royalties fees would be the end result for Elite?
11. How does Elite's ADT compare to other ADT products that purport to detour swalling a handful of pills? What would it take to get Elite to attach "similar" ADT. How does Elite's microtablet technology improve on Elite's existing ADT? What is the microtablet technology worth once Elite begins to market its ADT opioids?
12. Did Epic ever settle with Purdue?
13. Does Epic have plans to ramp up sales and marketing departments in anticipation of marketing ELI-200 or future ART drugs?
14. What are the chances of an Epic and Elite merger? What would a reverse merger do to the PPS?
15. What's the current status of Mikah and the relation between Mikah/Epic as well as any possible conflict of interest that relation can cause to Elite?
16. Will there be a new valuation/assessment?
17. Will there be any Pie Charts to show shareholders the increase in shares?
18. We seem to have been "flying under the radar" for quite awhile now. Does Nasrat plan on presenting at more conferences (Rodman and Renshaw and others) to promote awareness and interest in the company now that we are in the last stretch for ELI 200?
19. Since EPIC is going to be marketing its own ER ADT OXY and Elite's IR ADT OXY at the same time, which ADT will Epic be using.....Will it be a hard turtle shell version like Purdue/Actavis has agreed upon.......OR is EPIC going to be using a version of Elite's ADT?
20. What are the scenarios/circumstances that would engage Elite to pursue up listing to the Nasdaq or anything comparable?
21. The annual shareholders meeting - Status update?
22. What is the rational/need for issuing additional shares to Lincoln Park in light of the revenue that will be gained from the recent licensing agreement with Epic? If the goal is to uplist to Nasdaq, doesn't the continued issuance of shares impede this goal?
23. Status update on the new fluid bed dryer.
24. Regarding EPIC's Oxycodone Generic. Is it strictly EPIC's ANDA product? Did Elite help to develop EPIC's Oxycodone?
25. Elite requested and was granted accelerated filer status by the SEC. Why did Elite want to be an accelerated filer?
26.
**** Elite Pharmaceuticals Conference Call Questions ****
Those participating in ELTP’s Conference Call Q&A session are limited to asking one question following ELTP management’s opening statements. To make the most of this Q&A opportunity, 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. Any plans for ELI-154?
2. Now that the NDA filing is very near to completion, what are the status updates on ELI 201 and 202? Has the FDA given any indication (or have they been asked) about reduced trial requirements for ELI products that are similar to ELI 200? HAL studies and Phase 3s required for every single product?
3. Update on ELI-202 BE?
4. Any generics moving up the ladder to commercialization?
5. Elite had an agreement with Epic for 8 drugs where Elite gets a 15% profit split. Elite is 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?
6. Are there any numbers yet on the sales of Isradpin?
7. Status update on the arbitration of Phentermine with Precision Dose?
8. Given Elite's generic NDA ART line takes less time and money to bring to market than Elite's once daily Eli 216 product, what are the current plans for this product? How likely is it to partner a combo Eli 201 and 216 together? How quickly are you planning to move forward with this product since there is no other once daily abuse resistant product on the market?
9. What is the up to date information on the Public Float and Shares Outstanding for ELTP?
10. Given Nasrat's experience working at Alpharma and Actavis... Does he think Elite's patents are different enough from Purdue not to move toward legal avenues? If not, does Nasrat believe royalties fees would be the end result for Elite?
11. How does Elite's ADT compare to other ADT products that purport to detour swalling a handful of pills? What would it take to get Elite to attach "similar" ADT. How does Elite's microtablet technology improve on Elite's existing ADT? What is the microtablet technology worth once Elite begins to market its ADT opioids?
12. Did Epic ever settle with Purdue?
13. Does Epic have plans to ramp up sales and marketing departments in anticipation of marketing ELI-200 or future ART drugs?
14. What are the chances of an Epic and Elite merger? What would a reverse merger do to the PPS?
15. What's the current status of Mikah and the relation between Mikah/Epic as well as any possible conflict of interest that relation can cause to Elite?
16. Will there be a new valuation/assessment?
17. Will there be any Pie Charts to show shareholders the increase in shares?
18. We seem to have been "flying under the radar" for quite awhile now. Does Nasrat plan on presenting at more conferences (Rodman and Renshaw and others) to promote awareness and interest in the company now that we are in the last stretch for ELI 200?
19. Since EPIC is going to be marketing its own ER ADT OXY and Elite's IR ADT OXY at the same time, which ADT will Epic be using.....Will it be a hard turtle shell version like Purdue/Actavis has agreed upon.......OR is EPIC going to be using a version of Elite's ADT?
20. What are the scenarios/circumstances that would engage Elite to pursue up listing to the Nasdaq or anything comparable?
21. The annual shareholders meeting - Status update?
22. What is the rational/need for issuing additional shares to Lincoln Park in light of the revenue that will be gained from the recent licensing agreement with Epic? If the goal is to uplist to Nasdaq, doesn't the continued issuance of shares impede this goal?
23. Status update on the new fluid bed dryer.
24. Regarding EPIC's Oxycodone Generic. Is it strictly EPIC's ANDA product? Did Elite help to develop EPIC's Oxycodone?
25. Elite requested and was granted accelerated filer status by the SEC. Why did Elite want to be an accelerated filer?
26.
Fellow ELTP Investors,
Since indications are that ELTP could hold its Conference Call next week, I'd like to once again facilitate the collection of shareholder input for the Q&A session with ELTP management.
For those who have not participated in ELTP's Q&A session before, I'll repeat the purpose/intent of putting together the question list. Due to time constraints, callers who participate in the Q&A session are limited to asking one question. We’ve got some very knowledgeable shareholders here on iHub who are well versed in the pharmaceutical sector and can provide excellent questions. But they may not be available for the Conference Call or, if they do partake, will be allotted one question to ask. That’s where the rest of us 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 list with leftover questions from August’s Conference Call that were either not asked or are still relevant for updates. I've also added a couple new questions that were suggested on this Board recently.
Please note that my role is NOT to censor or editorialize submitted questions. If you have an opinion on what should or should not be asked at the Q&A session, 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.
MJ
CW,
If you could remind/point me to the weekly chart periodically, I'll keep iHub's ELTP intro updated.
Thanks,
MJ
My initial post was directed at dispelling accusations that Nasrat had lied about ELI-200 not needing a Phase III trial. It was actually the FDA who later added the Phase III requirement.
To expand on my conversation with Dianne... I had asked her about the FDA meeting that was suppose to determine filing requirements and the Phase III trial not being initially identified. Dianne said emphatically "We have it in writing". She owed it to the FDA not being familiar with ELTP's technology... That it was "new to them".
I don't agree with your assertion that the FDA later adding the Phase III requirement somehow equates to them also not fast-tracking ELI-200's NDA filing. You're comparing apples to oranges. If anything, the outstanding Phase III results should guarantee that the FDA will fast-track ELI-200's NDA filing.
Lastly, I'll close by saying Diane is not a liar. She has always been honest and helpful to me. Accusations about her, and Nasrat for that matter, are baseless and unfounded.
Would it make any difference if the FDA's statement didn't specifically mention the Phase III trial wasn't needed versus stating that there are no further requirements in order to file?
Add a month to be in line with what Nasrat has stated: NDA filed by the end of the year... A 6 month FDA fast track timeline puts approval sometime in June.
Kudos.... I couldn't have said it any better!
I have a simpler strategy... I'm selling when Nasrat sells.
Predictions of a 2 cent ELTP share price - Caveat Emptor.
Going to be pretty hard to spin against a closing shareprice of $.278 and a 13.89% gain from those who have been predicting for weeks would be 2 cents.
Very Nice finish for ELTP today!:
Last Price: $.278
+.0339 (+13.89%)
Volume 2,351,065
Let's pick it up tomorrow where we left off...
Rodger that, Snup...
More ink/eyeballs on ELTP:
http://ih.advfn.com/p.php?pid=nmona&article=69020915&symbol=ELTP
ATTENTION SHAREHOLDERS: Special Situation Alert - Small Cap Street
Date : 10/26/2015 @ 8:25AM
Source : InvestorsHub NewsWire
Stock : Elite Pharmaceuticals, Inc. (QB) (ELTP)
Quote : 0.2441 0.0 (0.00%) @ 7:48AM
ATTENTION SHAREHOLDERS: Special Situation Alert - Small Cap Street
Print
Alert
NEW YORK, NY – October 26, 2015 -- InvestorsHub NewsWire -- Small Cap Street makes the connection between sophisticated investors and high quality micro and small cap companies that are currently undervalued. We are an issuer of reports written by experienced financial analysts and who provide a straight forward assessment of profiled companies. They include stocks traded in the NYSE, NASDAQ, and OTCBB exchanges.
*Special Situation Alert Coming Tuesday, October 27th, 2015*
Small Cap Street and several other large media providers will be profiling an exceptional growth company that has some similarities to our last 200% winner.
This company recently executed a large reverse merger and is flying way under the radar. With an extremely tiny float we are expecting this to be one of our best alerts ever.
Be ready at 9:45 am EST on Tuesday, October 27th, 2015 by joining our group here: smallcapstreet.com
To receive profiles in real time, text "Street" to 25827
4 Brief Company Reports -
Viropro, Inc. (OTCBB: VPRO) through its subsidiaries, is engaged in the contract research, development, and manufacture of biotherapeutic proteins for the treatment of various diseases. The company is also involved in the transfer of its proprietary technologies for industrial production of biogeneric therapeutic proteins for the treatment of various diseases, such as cancer, diabetes, hepatitis, or multiple sclerosis.
VPRO has signed a non-binding Letter of Intent for the acquisition of NovaRx, a San pioneer in immuno-oncology, in an all-stock transaction that is expected to close by year-end. NovaRx has developed a method of activating the body's immune system to recognize and destroy cancer cells. In a Phase II trial, the company demonstrated a significant improvement in survival for patients with non-small cell lung cancer. A Phase III trial did not achieve its desired endpoint. The company's management believes that a properly designed and administered Phase III study will yield different results.
Kallo, Inc. (OTCQB: KALO) develops and delivers innovative, technologically advanced and turnkey healthcare solutions in the developing world and rural communities including infectious disease management, education and training programs. The company's mobile technology suite transforms the delivery of rural medicine, disease management, clinical globalization, and eHealth solutions.
KALO was recognized last month with the Frost & Sullivan 2015 Award for Emerging Market Innovation. This award recognizes Kallo's unique holistic approach to healthcare delivery. Kallo's modular approach caters to the specific healthcare needs of each region through a combination of polyclinics, mobile clinics, teaching institutions and telemedicine. This system is designed to serve such emerging nations as Guinea, Senegal, Nigeria, Peru, Brazil, Cameroon and Chad.
Urban Barns Foods Inc. (OTCQB: URBF) is a Canadian food producer growing fresh vegetables year round. Grown in a completely controlled environment, their vegetables are grown from non-GMO seeds and free of pesticide, herbicide, and fungicide. Controlled environment means no contact with the outside world, eliminating the possibilities of contamination and infection. The company specializes in leafy vegetables including lettuce and basil that are Kosher-certified.
URBF has undergone a restructuring of its executives this year making changes in the Chairman, CEO, and President and Directors positions. The company’s fiscal year ends July 31st. Recent financials indicate a drop in shareholder equity, primarily due to increased debt, and a better bottom line due to a significant cut in operating expenses.
Elite Pharmaceuticals, Inc. (OTCQB: ELTP) is a pharmaceutical company developing a pipeline of pharmacological abuse-deterrent opioid products and niche generic products. Elite owns generic and OTC products licensed to TAGI Pharma, Epic Pharma and Valeant Pharmaceuticals International with seven commercial products currently being sold.
The company has achieved positive top-line results from the Phase 3 pivotal trial of its lead opioid abuse-deterrent candidate, ELI-200, for the treatment of moderate to severe pain. There were no serious adverse events or deaths related to ELI-200 reported during the conduct of the trial. Elite intends to submit a New Drug Application to the U.S. Food and Drug Administration for abuse-deterrent ELI-200 by year-end.
Forward-Looking Disclaimer
This report may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward- looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of mentioned company to be materially different from the statements made herein.
Compliance Procedure
Content is researched, written and reviewed on a best-effort basis by a 3rd party research analyst. However, we are only human and may make mistakes. This report was prepared for informational purposes only. A full disclaimer can be found by viewing the full analyst report. We do not engage in high frequency trading or hold any positions of profiled company.
For more information and services provided beyond this release please use contact information provided below. If you notice any errors or omissions, please notify us below.
Source: Small Cap Street
toofun,
I spoke with ELTP's IR, Dianne Will, on Friday. She said their resources/attention are on focused on getting ELI-200 approved and preparations completed for its manufacture/marketing. She also mentioned that they are also working on advancing other drugs in their pipeline.
MJ