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First comes the volume...
...then comes the run.
Thoughts on IPCI's oxy ER
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=153059536
1. The poisonous blue dye in the first version of IPCI's oxyER was not a superfluous add-on. It had to be removed because it kills people in higher concentrations (You're welcome, America!). BUT, as poisonous as it is, the blue dye was a necessary component of the ADF because the drug can be chewed "like bubblegum," according to Dr. Odidi. Chewing is the most common route of abuse for ER opioids, and IPCI has never released the results of their chewing HAL studies. Without the blue dye, what is preventing anyone from chewing it, "like bubblegum"? If those HAL studies were successful, we would know about it by now, and we would be hearing about it over & over. No HAL results --> No confidence.
2. IPCI's Oxy ER is not Collegium's Xtampza. Collegium's drug is successfully challenging Purdue's OxyContin in the market because Xtampza is a totally unique formulation. It is superior to OxyContin in multiple ways but most especially in chewing resistance. Unlike Xtampza, IPCI's oxyER is an OxyContin clone. It has excellent syringeability data, which was revealed at the first AdCom, but we have never seen chewing or snorting HAL data. I highly doubt that IPCI's chewing data is even comparable to OxyContin, but even if it is, that will not get it approved. It has to be good enough to qualify for the same chewing ADF label that Xtampza has in order to be approved, and IMO, that is highly unlikely. And don't forget, IPCI's clone is still locked down in patent infringement litigation with Purdue.
3. The Odidi's recently expanded their loan to the company. If they had confidence in the drug's impending success, why wouldn't they buy shares instead giving another loan? Likewise, when the company was desperately trying to increase shareholder equity to maintain NASDAQ listing, the Odidi's never converted their loan to shares, which would have made the job much easier to accomplish. Dr. Odidi has also started a new venture in China. If the CEO shows no confidence in the future of the company, then why would I?
IMO, FDA will not look favorably on a chewable OxyContin clone. But if you have a strong stomach, be my guest. However, if you hold through the Adcom, I recommend wearing Pampers on January 15. Whatever happens to IPCI's drug on that day, it doesn't change the fact that the ADF opioid market has never developed as everyone hoped. With the exceptions of OxyContin and Xtampza, every other ADF drug is a miserable failure.
Whoa there, Cowboy.
***** MUST READ ----- IPCI not playing games!!!!!!!!!!!!!!!!!!! *****
Abuse-deterrent FULL STEAM AHEAD!!!!!
300% return in just the past 4 weeks!!!!!
ELTP better get on board .............. RIGHT NOW!!!!!
Welcome to the next phase...
Yesterday was the biggest day in the history of Elite Pharmaceuticals. We have never had any product with this much upside potential. It is particularly beneficial that the company has API quota in place and is ready to ship product within a few weeks to a distributor with the name and infrastructure to immediately start gaining market share. I say this is the "next phase" for two reasons: the IR and ER Adderall products will (1) make this company profitable (E is for earnings) and (2) allow further development without further dilution.
Congratulations to all long term investors. This is what we've been waiting for. Lots of investors have found this stock along the away, but I offer special praise to those investors with the insight and patience necessary to recognize the ongoing potential despite the recurrent setbacks. And while I am praising insight and patience, let's not forget Elite management. While the future of ADF opioids is in doubt, the future of Elite Pharmaceutical is very clear. For that fact alone, I give Nasrat Hakim great credit. I believe he showed true vision and was ahead of his peers in seeing problems in the ADF market and general decline in opioid prescriptions. The timely transition to ADHD drugs was a smart choice that aligns perfectly with Elite's model of niche drugs with high barriers to entry. The team has the facilities well-prepared, and the right products are starting to line up.
The next phase will require a second shift. It's time for our factory to get busy. We've literally got a license to cook crank, so let's really start slinging that speed!
Jenga!
That crazy tower was going to come tumbling down at some point- it always does. Can I keep my Antigen stock, or is that dividend also in divi-doubt?
If this MSO-pharmacy-wound care-surgery supply thing doesn't work out, maybe they should think about doing something with our totally unique, patented buccal insulin technology that has the potential to revolutionize diabetic management. Or just do the MSO. Whatever.
I would have lost that bet.
Purdue BK *before* IPCI.
¯\_( )_/¯
https://www.intellipharmaceutics.com/news-media/press-releases/detail/210/intellipharmaceutics-announces-an-update-in-the-purdue
Intellipharmaceutics Announces an Update in the Purdue Litigation
October 04, 2019
Intellipharmaceutics ..... announced today that following the filing of a bankruptcy stay by Purdue Pharma L.P., the Company's ongoing litigation cases .... have been stayed and the existing trial dates in both cases have been vacated by orders issued in each case by the judge in the District of Delaware on October 3, 2019.
....
The previous 30-month stay date of March 2, 2020, remains unchanged at this time, absent a further order of the judge.
Sounds like a sucker's bet.
Need to increase your sale/buyout price.
https://www.raps.org/news-and-articles/news-articles/2019/9/fda-consults-on-abuse-deterrent-cns-stimulants
Thanks.
That'll show him!
My votes as of TODAY:
AGAINST (2) To amend our Articles of Incorporation to increase the number of shares of common stock the Company is authorized to issue from 995,000,000 shares to 1,445,000,000 shares
In addition, solely during any period commencing four years after the issuance of the Series J Preferred, provided that the Authorized Share Deficiency still exists, until such time as the Authorized Share Deficiency no longer exists, holders of the Series J Preferred are entitled to receive dividends at the rate per share (as a percentage of the Stated Value per share) of 20% per annum, payable quarterly. As discussed above, in the risk factor “If we are unable to increase our authorized shares of common stock, our ability to raise additional funds most likely will be materially adversely affected. Our inability to increase our authorized shares also will result in a requirement to pay significant annual dividends pursuant to our outstanding shares of Series J Preferred Stock” we plan on holding an annual meeting of shareholders on a date during the calendar year 2019 which has not yet been determined, at which time the Company will seek an increase in our authorized shares of Common Stock (the “Proposal”).
I didn't say I loved it.
Not sure I agree. Last cc, Nasrat was stating he needs only $1-2M for sourcing and operations. If CNS is approved in Dec, Elite becomes CFP early 2020. No need for this big of authorization at this point. I don’t think that is judicious.
+500 million. Seems judicious.
https://sec.report/Document/0001213900-19-019201/
To amend our Articles of Incorporation to increase the number of shares of common stock the Company is authorized to issue from 995,000,000 shares to 1,445,000,000 shares;
I remember when you said "Within 18 mos. I expect ELTP will be bought out." although I couldn't tell you the date you said it!!!
And, Weezuhl; am surprised he's not around
Latest image from my DD-Drone
Looking Good!
Currently on the East Coast leg of its late summer rounds, my DD-Drone shows the company appears to be very busy. This is currently the only meth lab in my investment portfolio. They seem to be at capacity- cooking up crank and slinging speed. College students rejoice! Your uppers are on the way.
Looking forward to seeing some numbers next week.
Whatever happens Mr Odidi is always "pleased".
Can't he just say...we are disappointed once in a while.
This is probably good for IPCI. They could have been torn up at AdCom for most likely poor results on chewing HAL studies, with subsequent CRL crash. But now the application goes to purgatory. Instead of a two-time loser, they still have a potential asset in the form of a pending NDA, for who knows how long.
The FDA informed the Company that it would continue to review the Company’s NDA according to the existing Prescription Drug User Fee Act (“PDUFA”) timeline, but noted that, due to the postponement of the AADPAC meeting, it is possible that the FDA may be unable to meet the PDUFA goal date of August 28, 2019.
This is a significant roadblock for any company developing opioids
The FDA informed the Company that it would continue to review the Company’s NDA according to the existing Prescription Drug User Fee Act (“PDUFA”) timeline, but noted that, due to the postponement of the AADPAC meeting, it is possible that the FDA may be unable to meet the PDUFA goal date of August 28, 2019.
Wowsers something's up with FDA & opioids
Intellipharmaceutics International Inc. Announces Update on its Oxycodone ER New Drug Application
July 24, 2019
TORONTO, ON / ACCESSWIRE / July 24, 2019 / Intellipharmaceutics International Inc. (OTCQB: IPCIF and TSX: IPCI) ("Intellipharmaceutics" or the "Company,") a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, announced today that it has been advised by the U.S. Food and Drug Administration’s (“FDA”) that the FDA “is postponing product-specific advisory committee meetings for opioid analgesics,” including the one previously scheduled to discuss the Intellipharmaceutics New Drug Applications (“NDA”), “while it continues to consider a number of scientific and policy issues relating to this class of drugs.” According to the FDA, the reason for the postponement is not unique to our product and the Anesthetic and Analgesic Drug products Advisory Committee (“AADPAC”) meeting earlier planned by the FDA, to discuss our NDA will be rescheduled at a future date.
The FDA informed the Company that it would continue to review the Company’s NDA according to the existing Prescription Drug User Fee Act (“PDUFA”) timeline, but noted that, due to the postponement of the AADPAC meeting, it is possible that the FDA may be unable to meet the PDUFA goal date of August 28, 2019.
Dr. Isa Odidi, CEO of Intellipharmaceutics, stated, “we are pleased that the FDA will continue to review our New Drug Application (“NDA”) according to the existing Prescription Drug User Fee Act (“PDUFA”) timeline despite this new development.”
There can be no assurance that the meeting to discuss our NDA will be re-scheduled as planned or at all. There can be no assurance that Intellipharmaceutics will not be required to conduct further studies for Oxycodone ER, that the FDA will approve any of the Company's requested abuse-deterrent label claims or ultimately approve the NDA for the sale of Oxycodone ER in the U.S. market, or that it will ever be successfully commercialized.
Intellipharmaceutics International Inc. Announces Update on its Oxycodone ER New Drug Application
July 24, 2019
TORONTO, ON / ACCESSWIRE / July 24, 2019 / Intellipharmaceutics International Inc. (OTCQB: IPCIF and TSX: IPCI) ("Intellipharmaceutics" or the "Company,") a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, announced today that it has been advised by the U.S. Food and Drug Administration’s (“FDA”) that the FDA “is postponing product-specific advisory committee meetings for opioid analgesics,” including the one previously scheduled to discuss the Intellipharmaceutics New Drug Applications (“NDA”), “while it continues to consider a number of scientific and policy issues relating to this class of drugs.” According to the FDA, the reason for the postponement is not unique to our product and the Anesthetic and Analgesic Drug products Advisory Committee (“AADPAC”) meeting earlier planned by the FDA, to discuss our NDA will be rescheduled at a future date.
The FDA informed the Company that it would continue to review the Company’s NDA according to the existing Prescription Drug User Fee Act (“PDUFA”) timeline, but noted that, due to the postponement of the AADPAC meeting, it is possible that the FDA may be unable to meet the PDUFA goal date of August 28, 2019.
Dr. Isa Odidi, CEO of Intellipharmaceutics, stated, “we are pleased that the FDA will continue to review our New Drug Application (“NDA”) according to the existing Prescription Drug User Fee Act (“PDUFA”) timeline despite this new development.”
There can be no assurance that the meeting to discuss our NDA will be re-scheduled as planned or at all. There can be no assurance that Intellipharmaceutics will not be required to conduct further studies for Oxycodone ER, that the FDA will approve any of the Company's requested abuse-deterrent label claims or ultimately approve the NDA for the sale of Oxycodone ER in the U.S. market, or that it will ever be successfully commercialized.
LOL
Forget the ADF folly....Xtampza selling like crazy...because it prevents the most likely ways of abuse..
But like I said, it will be based on the oral results... Which they have not published... So place your bets... This is a long shot... But in the event they do get approval, this will run hard. But the odds are more than 20 to 1 against.
An 505(b)2 NDA can be marketed as generic, in addition to name brand, if the FDA gives it a TE Code of AB. Since company is just calling the drug "Oxycodone ER", I assume that is the path IPCIF is seeking. If you look up an NDA there is a column for "TE Code" and Therapeutic Equivalents for NDA are listed at the bottom.
Camargo says there are AB Rated 505(b)(2) NDAs:
https://camargopharma.com/resources/blog/ab-rated-505b2s
I assume FDA gives guidance on what abuse studies were required after the 1st AdCom. Did FDA say they needed a "successful chewing study" to get approved?
I was just guessing no Advisory Committee meeting, since I have not heard of one scheduled yet. Does not FDA need to give company time to prepare for an Adcom and time for FDA to consider Adcom advice? IPCIF's 1st AdCom was announced about a month before the meeting and was scheduled about 2 months before PDUFA. It is getting too late to 2nd PDUFA date to schedule an AdCom.
Dangerously incorrect.
It seems Oxycodone ER is basically a generic of Oxycontin. I am guessing FDA will not hold another Advisor Committee meeting since is it so close to being a generic. All IPCIF has to do is show Oxycodone ER is equally as abuse-resistant as Oxycontin to get approved. IPCIF claims Oxycodone ER is bioequivalent with or without food so the drug meets the requirement to be generic AB-rated.
Doing nothing has stopped Elite
Well said.
I am rather surprised why they got the going concern if Methadone was continuing growing. Big snag(s) during Q4. This period was supposed to be teeing up the company near and long term. We’ll know soon enough, but the silence is deafening.
Naz Has too much of his own money here at risk to not have all contingencies covered. Will know soon but he’s got too much To lose or gain for him not to be prepared as he is a very intelligent person. Just feel this is knee-jerk and will more than work itself out in the days to come!
According to the company news, there is no number given out yet, why the stock was down over 30%?!
The auditor’s opinion on the Company’s financial statements for the year ended March 31, 2019 is expected to contain an explanatory paragraph with respect to there being substantial doubt as to the Company’s ability to continue as a going concern and the Company expects to continue to incur losses until it is able to generate sufficient revenues to support its operations and offset operating costs.
Calcium Channel Blocker Flops in Parkinson's Disease Trial
—"Disappointing" results from 3-year study don't back prior findings
by Elizabeth Hlavinka, Staff Writer, MedPage Today
May 02, 2019
https://www.medpagetoday.com/meetingcoverage/aan/79590
PHILADELPHIA -- An anti-hypertensive drug failed to outperform placebo in slowing Parkinson's disease progression, results from the highly-anticipated STEADY-PD III trial indicated.
No significant difference was seen after 36 months in average Unified Parkinson Disease Rating Scale (UPDRS) Part I-III scores measured in the ON state for patients receiving isradipine (DynaCirc) at 10 mg daily versus placebo (treatment effect 0.27 points, 95% CL -2.5 to 3.0, P=0.85), reported Tanya Simuni, MD, of the Northwestern University Feinberg School of Medicine, and colleagues.
This should surprise nobody.
The only people who benefit are the Odidi's who now get to convert the stock at 1.7 million NEW shares or roughly 9% of the outstanding new shares?
How is this fair to shareholders? His debenture should still be subject the same reverse split as everyone else.
The shares I hold now I bought at $ 0,08 a share (1/21 of $ 2) They are now $ 1,50 a share. I think that having this investment for over a year is long, you may disagree.
Missing the point.
I did not sell all my shares, I still own a lot of them. My gaines are based on the present price of 1,50 a share.
Just like I said....
I bought my shares beginning last year for $ 2 a share. You might find that short term, I do not. I have not lost money with them since. I made several times my initial investment of $ 2.000. A gain of over 1.400%.
Those are just the facts.
The future can be debated, but there is no denying the success of GNBT longs.
but the worst part is that the majority of us didn't know at the time that IPCI was receiving CRL's they weren't disseminating to market...so even if Odidiot and Della Penna found higher quality funders, the fact remains that IPCI proved completely incapable of receiving any timely FDA approvals, so in the end all they did was dilute 100's of millions of dollars worth of stock that resulted in no relevant return in value...
I don’t have a real good link, but I saw the patent expiration date somewhere. It looks like Shire’s patent for Adderall XR is set to expire April 21, 2019. Could that be what we are waiting for? If I read it correctly, other companies were able to sell a generic but they gave Shire royalties.
Some may want others to believe everyone in the investment & medical community are ignorant and unable or too lazy to research who may benefit from an Isradipine approval for PD. Utter nonsense!!
Allow me to reiterate...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=147745017
It is important to note that this report is not applicable to isradipine, which is a truly unique situation. This will not be an FDA regulatory decision. The research was not sponsored by Elite, and Elite will not be mentioned in association with the research results. I am not sure the market will appreciate the connection between ELTP and STEADYPD-III, at least until it hits an earnings report. Good results will be good for Elite, the old-fashioned way, by selling more product in response to increased demand. I'll take that all day, but I continue to urge for tempered expectations regarding an immediate effect of isradipine news, even great news.
Great info!
Amerisource Bergen...it's a preferred brand now and as far as I see cheapest available too!!
Ok let’s split hairs, .08-.098... fact is all the great anticaption, but market speaking volumes to the contrary.
can't help but wonder what's going on with the interest in the stock, with all the great things, but yet having a hard time holding on to .09, who's selling, with such great news on having a potential parkinson drug. IMO something sure doesn't look right.
dest_golf Wednesday, 03/27/19 07:39:09 PM
Re: None
Back 8nto the .08 range tomorrow..
IMO something sure doesn't look right.
CLINICAL TRIALS PLENARY SESSION
Tuesday, May 7, 2019
11:00 AM - 11:15 AM
A Phase 3 Study of Isradipine as a Disease Modifying Agent in Patients with Early Parkinson’s disease (STEADY-PD III): Final Study Results
Tanya Simuni MD
Let's not fight disinformation with disinformation.
I am clear on that. My simple and humble observation is that he had filed a form-4 just a month ago showing that he acquired 201,717 ELTP shares @ .1239 costing roughly $25,000.
...
This simple and publically verifiable information shows insiders were buying ELTP at a PPS that is higher than its current levels, during a time that some claimed insiders were dumping.
ATTENTION: The person for whose account the securities to which this notice relates are to be sold hereby represents by signing this notice that he does not know any material adverse information in regard to the current and prospective operations of the Issuer of the securities to be sold which has not been publicly disclosed.