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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.
Just posting this again to make sure you saw it.
As I said before, they love to make news at these conferences, and newsworthy results are always embargoed prior to the presentation, so I would not be looking for any abstracts or leaks before the date.
EMBARGO POLICY FOR 2019 AAN ANNUAL MEETING ABSTRACTS
The embargo for emerging science abstracts (formerly known as late-breaking scientific abstracts) to be presented at the AAN Annual Meeting, remains in effect until 12:01 a.m. ET, Friday, May 3, 2019, unless otherwise noted by the AAN Media and Public Relations Department.
Emerging science abstracts are not posted online in advance of the AAN Annual Meeting. Emerging science abstracts are accepted from neurologists, neuroscientists, and other researchers whose work is of major scientific importance, warranting expedited presentation and publication. Key aspects of the research must have been conducted after October 22, 2018.
lol lol I never suggested there was no futility analysis
Not only did the study pass through the futility checkpoint, that checkpoint was complete 3 year data on 168 patients. Many full studies aren't even that big. The study was designed to detect if there was at least 25% slowing of functional decline with isradipine, and it would have been stopped if it didn't look like it was happening after 50% of participants had completed the study.
It is futile to suggest no futility checkpoint...
https://pdfs.semanticscholar.org/7d4c/09dd2d8333277b8ffe287609e0982f0ce26a.pdf
Interim analyses
An interim analysis for futility and efficacy will be performed after primary outcome data are available for the first 168 participants (50%) to enroll. The study will be terminated for futility if the interim analysis shows that the conditional power of rejecting the null hypothesis in favor of a beneficial effect of isradipine is lower than 20% under any scenario that is consistent with the data accrued at that time. A two-sided P-value in favor of isradipine of less than 0.001 will be required to stop for efficacy at the interim analysis. The stringent alpha level for efficacy was chosen so as to have minimal effect on the final P-value, should the study run to completion. In addressing futility, the DSMB will examine a range of possible treatment effects consistent with the data obtained in the study at the time of analysis.
The FDA should have nothing whatsoever to do with anything. As you yourself have stated word has pretty much been mum with regard to this drug and its potential use for PD. Study results will be out in early May.
...
Highly doubt anything has been said about anything with regard to study results. And having said that results are pretty much under lock and key until early May how would anyone be privy to results?
What do you know about the company's intentions for a PR in the event the results are good? Easily justifiable as a material event to try to associate ELTP's isradipine with STEADYPD-III, but very, very sticky territory with the FDA. They tend to frown upon drug companies advocating for an off-label use of any drug.
Trends in company stock prices before the first public announcement differ for companies that report positive vs negative trials. On that point, here is some research that found an impact on the p/s following FDA announcements ...
an unwarranted sense of entitlement from people who feel participant trophies are the same as first place
Your thoughts on why the STEADY-PD III clinical trial results are not listed on the program yet?
They love to make news at these conferences, and if the results are newsworthy, they will most likely be in one of the Plenary Sessions ("Premier sessions highlighting the latest advances in neuroscience and presented by some of the most well known and respected thought leaders in the field of neurology.") If it gets added to a lower level session, probably not good. If it gets added to Saturday's Plenary ("Hot Topics") or Sunday ("Presidential") then we are golden. Tuesday ("Clinical Trials") is probably still okay. If it drops all the way to Friday ("Neurology Year in Review") then we are screwed.