You will. cos this stock went to $20 plus in 2018*. Biotech stock is a different kind of animal because when there's a really good news , you can easily make 50% gain in a day .

NOW, THEREFORE in consideration of the mutual covenants and agreements contained herein, the sufficiency, adequacy and satisfaction of which are hereby
acknowledged, Glenmark and Elite hereby agree as follows:

1. The Parties agree to amend the Agreement by terminating the license for Methadone HCl 5mg on December 31, 2019 and 10mg tablets and Phendimetrazine 35mg tablets on February 28, 2020.

I bet Elite will try and sell each one of these, Methadone and Phendimetrazine, just as they did with the other 3 drugs; Norco, Percocet, and Hydromorphone.

Asserall IR

How Methamphetamine Became a Key Part of Nazi Military Strategy
BY PETER ANDREAS JANUARY 7, 2020

In The Art of War, Sun Tzu wrote that speed is “the essence of war.” While he of course did not have amphetamines in mind, he would no doubt have been impressed by their powerful war-facilitating psychoactive effects. Amphetamines—often called “pep pills,” “go pills,” “uppers” or “speed”—are a group of synthetic drugs that stimulate the central nervous system, reducing fatigue and appetite and increasing wakefulness and a sense of well-being. The quintessential drug of the modern industrial age, amphetamines arrived relatively late in the history of mind-altering substances—commercialized just in time for mass consumption during World War II by the leading industrial powers. That war was not only the most destructive war in human history but also the most pharmacologically enhanced. It was literally sped up by speed.

...

While other drugs were banned or discouraged, methamphetamine was touted as a miracle product when it appeared on the market in the late 1930s. Indeed, the little pill was the perfect Nazi drug: “Germany, awake!” the Nazis had commanded. Energizing and confidence boosting, methamphetamine played into the Third Reich’s obsession with physical and mental superiority. In sharp contrast to drugs such as heroin or alcohol, methamphetamines were not about escapist pleasure. Rather, they were taken for hyper-alertness and vigilance. Aryans, who were the embodiment of human perfection in Nazi ideology, could now even aspire to be superhuman—and such superhumans could be turned into supersoldiers. “We don’t need weak people,” Hitler declared, “we want only the strong!” Weak people took drugs such as opium to escape; strong people took methamphetamine to feel even stronger.

It's easy to crush

Hello WeeZuhl and the ELITE board,

Intellipharmaceutics is having their Adcom THIS Wednesday

Ouch. Not only is it a total failure in both oral and intranasal drug liking studies, but snorting IPCI's formulation actually results in SUBSTANTIALLY higher blood concentrations of oxycodone when compared with snorted OxyContin and snorted OxyIR. Ruh-roh, Elmo.

It will all come down to the chewing and snorting HAL studies.

• The ground IPC oxycodone ER tablets were associated with 67% higher Cmax, 122%
and 97% higher partial AUCs (AUC0-1h and AUC0-2h, respectively), 26% higher AUCinf,
and 1.5 h earlier median Tmax compared to crushed oxycodone IR tablets.

• The ground IPC oxycodone ER tablets were associated with 64% higher Cmax, 78%
and 63% higher partial AUCs (AUC0-1h and AUC0-2h, respectively) and 0.5 h earlier
median Tmax compared to ground OxyContin tablets.

Weezuhl- Will you be attending the Intelli Adcom next week?

In February 2018, the Company met with the FDA to discuss the above-referenced CRL for Oxycodone ER, including issues related to the blue dye in the product candidate. Based on those discussions, the product candidate will no longer include the blue dye.

But what I take exception to is the repeated posts about how Rexista is based on some unique ADF technology that is patented and proprietary. It very simply IS NOT. It is not patented, and it is not unique, other than the poisonous blue dye, which we all know will never make it into the final formulation that gets approval. Take the blue dye out of Rexista, and what you're left with is very expensive generic OxyContin that can be chewed "like bubblegum."

Rexista might be the best to chew while in class, but it will never be "Best In Class."

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.

***** 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!!!!!

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.

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.

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”).

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.

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

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.

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.

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.

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

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.

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.

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.

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.