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Treatments for Mad Cow, Other Prion Diseases May Be Coming NEIL WAGNER OCTOBER 11, 2011
Researchers at NYU have made a key step in developing a treatment for Creutzfeldt-Jakob and a host of other brain-wasting diseases
There are currently no treatments for prion diseases, brain-wasting diseases that are invariably fatal. The most common human prion disease is Creutzfeldt-Jakob disease (CJD), better known as mad cow disease. Researchers at NYU School of Medicine recently took a key step in developing an effective treatment. They found four compounds that significantly delayed disease onset in mice. Because prion diseases are extremely slow to develop, any treatment that delays their initial symptoms long enough could potentially be life saving. And two of these anti-prion compounds are drugs already used to treat other conditions in humans, meaning that clinical trials of them may soon be underway.
The two drugs are trimipramine, an antidepressant, and fluphenazine, an antipsychotic.
Tricyclic antidepressants Tricyclic antidepressants, like Desipramine, are heterocyclic compounds Figure 2 which have been shown to abolish prion infectivity in cell culture [60] The anti-prion effect was related to the redistribution of cholesterol from the plasma membrane to the intracellular compartment. This leads to membrane destabilization. In this study there were ultra-structural changes in the endosomal compartment. When these authors synthesized a novel compound of quinacrine and desipramine (quinapyramine) it had a synergistic effect in preventing prion infectivity. Of interest, the anti-prion effects of desipramine, quinacrine, quinapyramine were synergistic with simvastatin, a HMG CoA reductase inhibitor.
There is no human data on the effects of tricyclic antidepressants on prion diseases. Caution must be exercised in the use of tricyclic antidepressants as a reversible toxic neurological syndrome resembling prion diseases has been described [61].
"Going Concern" language appears to be in past tense.
From my initial reading, the auditor’s statement no longer contains an opinion expressing substantial doubt as to the company’s ability to continue as a going concern.
We have not been profitable and may not be profitable in the future.
To date, we have not been profitable, and we may never be profitable or, if we become profitable, we may be unable to sustain profitability. We have sustained losses from operations in each year since our incorporation in 1990. During the years ended March 31, 2020 and 2019, we incurred net losses from operations of approximately $2.3 million and $9.2 million, respectively. In addition, in certain years prior to the year ended March 31, 2020, including, without limitation, for the year ended March 31, 2019, the auditor’s opinion on the financial statements were qualified with respect to there being substantial doubt as to the Company’s ability to continue as a going concern due to continued losses not being sufficiently offset by operating revenues. A failure to generate sufficient revenues to offset related costs of operations will have a material adverse effect on our business, results of operations, financial condition, cash flow and ability to operate in the future.
Loan received pursuant to the Payroll Protection Program
In April 2020, the Company was approved for, and received a loan with proceeds of $1.01 million under the Paycheck Protection Program (“PPP”). The PPP, established as part of the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), provides for loans to qualifying businesses, with the amount of the loan being determined by application of a formula defined in the CARES Act that is based, in large part, on payroll expenses incurred by the Company. Amounts received pursuant to the PPP are intended to fund qualifying expenses, as defined in the CARES Act, which include, without limitation, employee payroll, health care benefits, rent and utilities, mortgage payments and interest on other debt obligations incurred prior to February 15, 2020.
Under the terms of the PPP, certain amounts received as a loan may be forgiven if they are used for qualifying expenses.
Any feedback from physicians on the board that have patients taking Lannett’s generic Adderall IR/ER?
I think it is important to remember that a generic substitute can be approved by the FDA if it is between 75-125% bioequivalent with brand name product. The hour by hour pharmacokinetics will look different. Each individual will react differently to different formulations. I see a lot of comments about additives and such, but the real reason people prefer one manufacturer over another is because of the differences in the pharmacokinetic curves of the active ingredient. It is unlikely additives have anything to do with it. It stands to reason that any person who has been taking a particular product for a long time, especially a strong drug like Adderall, will notice the difference when they suddenly have to change to a different formula. If they are getting more active ingredient sooner, they will feel the symptoms of overdose (anxiety, palpitations, etc). If they are getting less active ingredient or getting it later, they might feel the symptoms of withdrawal (lethargy, headache, etc.). Some folks are exquisitely sensitive to changes like this, some will barely notice. Some folks will like the change, some folks will not. I don't think it means one is better than the other, it just indicates they are different.
When a pharmacy customer complains about getting a new generic drug from different manufacturer, they are really complaining about the CHANGE rather than the manufacturer. What is most beneficial to the patient is to keep it consistent from fill to fill. Even the people who complain about the new formula will adjust to it and do fine as long as they continue to get the same formula each time. Pharmacists and pharmacy buyers know this, and they know they will get more complaints if they have to substitute a new manufacturer because the usual product is not available (no matter how good/not good the substitute might be). It really is a problem and is unfair to the patient if they are forced to accept a different manufacturer with each fill. Most patients are restricted by their insurance and cannot shop pharmacies for the drug they want, so they complain bitterly to the pharmacist and online whenever it happens, especially if it happens routinely. These are the kinds of considerations that cause the Walgeens buyer to choose Lannett over TEVA. It is a huge opportunity for Elite, but it is also a tryout. Walgreens knows they will get more complaints initially, but what they want from their distributor is a consistent supply. If Elite and Lannett can supply a quality product without recurrent shortgages, then the buyer will continue to click the Lannett button. But if they can't...
Back in the Before Times when I was a young ER doc in the I-10 corridor, during the heyday of the OxyContin Express, drug-seekers would actually request that I write on the prescription "Blue Lor-tabs only." (Actually, the Southern pronunciation is "Lora-Tabs"). They didn't want the white ones. Sometimes we would do 48 hour shifts out in the boonies, and people would call ahead to see which doctor was on duty. The locals knew us all by name, but the I-10 brought us lots of players. It was a regular occurence that one patient would be discharged from the ER and five other people would get up and walk out of the waiting room. There is no sense in going through the bother of an ER visit if all they're going to get is 10 dang white Lora-Tabs.
I'm not sure that is true. Maybe a reason we have not yet seen the generic Concerta ANDA filing from Elite is because Lannett **IS** going to be our distributor? Lannett currently distributes generic Concerta through a "perpetual licensing agreement" with Andor pharmaceuticals. It is the only ANDA listed for Andor, which is listed as a foreign LLC. The details of the arrangement are confidential, but here's the flavor:
Item 1.01 Entry into a Material Definitive Agreement On July 30, 2108, Lannett Company, Inc. (the “Company”) entered into a license agreement (the “License Agreement”) with Andor Pharmaceuticals, LLC (“Andor”), pursuant to which Andor granted the Company an exclusive license (the “License”) with respect to all rights and interests of Andor in and to the ANDA Application for Methylphenidate Hydrochloride (the “Products”). As consideration for the grant of the License, the Company has agreed to pay Andor (a) $1,500,000 in cash, of which $500,000 was paid at closing and $1,000,000 will be paid upon approval by the United States Food and Drug Administration (“FDA”) of an AB rating with respect to the Products (the “AB Rating Approval”), and (b) royalties based upon the net profits realized from the sale of the Products by the Company. The License Agreement, as amended by Amendment No. 1 to License Agreement dated August 2, 2018, by and between the Company and Andor (the “Amendment”), requires the Company to make minimum royalty payments to Andor during the initial four year period following the first commercial sale of the Products by the Company of $16,000,000 (the “Royalty Guaranty”). The amount of the Royalty Guaranty will be reduced by $4,000,000 for each application, if any, by a third party with respect to the Products that both receives regulatory approval from the FDA and is commercially launched after February 2, 2019 and prior to the receipt of the AB Rating Approval. Each party can terminate the License Agreement for, among other things, the failure of the ANDA Application to be approved by the FDA within specified time periods or the breach by the other party of its obligations under the License Agreement.
The only thing I know about "perpetual licensing agreements" is the undeniable fact that if my computer is working properly for more than 24 hours then Microsoft will immediately and automatically perform a mandatory Windows update that will screw it all to hell by the next morning. Maybe Lannett is tired of Andor's automatic updates, or the pharmaceutical equivalent. Maybe it is just not a good deal for Lannett. Whatever the deal is between Lannett & Andor, it seems to be structured over 4 years from the start of sales, which was some time in mid 2019. Lannett previously dumped Kremers version of generic Concerta because of bioequivalency problems, so they have proven they will make a big move for a better product.
Again, this is pure conjecture. I was hoping to see the Concerta ANDA filed before now. Thinking of possible causes of a delay, one obvious reason would be that Lannett's royalty deal with Andor is in place until mid-2023, three years away. Maybe the reason we haven't seen an application is because there is still plenty of time to get approval and be ready for launch with Lannett in 2023. Just a guess.
Damn. I thought I was about to get a new baby back secret. I'm more into bourbon than beer, but hell, I've got room in my life for all three- baby backs, bourbon, AND beer.
It will be easy enough to figure out in due time. Until then, I will reserve my baseless speculation. I agree that this change is precedent to an eventual buyout, but I disagree that it indicates anything about the timing of the buyout. It needed to be done, and it has been.
In regards to annual GDUFA fees, a medium-sized pharma has between 6-19 approved ANDA. I count 13 unique active ANDA listed in the FDA Orange Book for Elite Labs
It's kind of like gin. You have to put down cards to pick up cards. With 13 listed ANDA, Nasrat has room in his hand for 6 more cards, to make 19. That's when things get interesting. And that's why I want to see more ANDA applications soon and soon again.
We NEED to know your DOCTORATE degree level thinking on why BOTH Adderall products were JUST switched to Elite's name.
Because that's the way it was supposed to be. I don't know for sure why they did it like this, but the CNS stimulant ANDA's were always meant to be listed under Elite Labs. I'm glad to see it done, but it's just bookkeeping, IMO. It is interesting, though. Nice DD, Sharkey.
And technically speaking, after medical school, most doctors complete an internship and residency (hi UPMC!), so their level of thinking should be rated as "post-doctorate." Hey thanks a lot.
The question becomes if that’s an issue for Elite and raises the amount they owe to the FDA, that they were trying to avoid (~$2M).
In regards to annual GDUFA fees, a medium-sized pharma has between 6-19 approved ANDA. I count 13 unique active ANDA listed in the FDA Orange Book for Elite Labs, and there are also 3 discontinued ANDA. The ANDA's cover the 11 drugs listed on the Elite website products page (link below). The reason there are 13 ANDA and only 11 drug products is because Elite has 4 active ANDA for phentermine but lists only 2 current phentermine products. (Interestingly, the 3 ANDA listed as discontinued are also for phentermine.)
Quote: “The extent of the delay in the absorption and peak concentration of oxycodone from SequestOx under the fed conditions is unacceptable”.
This drug has been dead since 2014. If not dead, it is severely wounded. Somebody should put it down and out of its misery since Nasrat cannot bring himself to do it. The upcoming meeting with the FDA should not be about some bullshit apple sauce trial. Rather, they should convince (beg) the FDA to allow for a re-submission with a reformulated oxy bead. The naltrexone bead stays the exact same, and its safety and effectiveness have been proven in the HAL studies and the two Phase 3 studies- bunionectomy and methadone withdrawal. Those studies stand valid as proof of the naltrexone bead. Re-do the oxy bead, get it right, redo pivotal bioequivalence, get approval with a clean label, and proceed on with an awesome product that doctors will feel comfortable prescribing.
Do the right thing, Nasrat. This is our flagship and you're going to encumber it with a bullshit label? Fix it now. You've already doubled-down on this zombie bead- don't waste more time and money on it. A new bead and a new pivotal bioequivalence wouldn't take much longer or cost much more than your apple sauce escapades. It is not too late to make this right.
When .? Don't know, but this is U.S. they could still make it in Israel..
Guess they sold it to Shire.
No. Let's try again. TEVA's first ANDA for Adderall XR was never used and has been discontinued, but they acquired a second ANDA from Actavis. So TEVA still makes generic Adderall XR using the Actavis ANDA. They never stopped. Shire/Takeda has the original NDA, and they manufacture & market brand name Adderall XR. Prasco markets an authorized generic manufactured by Shire/Takeda under the NDA.
Our product is we have the authorized generic for Adderall XR. Our product is made for us by Takeda, which was formally Shire. Takeda acquired Shire. Our product is the authorized generic. It is the brand product Adderall XR, marketed as a generic.
We did have the Teva label product back when we first started getting the authorized generic. Teva did have an agreement with, at that time, Shire, with marketing the authorized generic.
Yes, TEVA's ANDA for generic Adderall XR has been offically discontinued in the FDA Orange Book (see below), but that does not mean they have stopped selling it. First, as far as I am aware, no drug was ever sold under that ANDA. FDA approved TEVA's ANDA, but there was a scheme with Shire/TEVA/Impax to sit on the newly-approved ANDA's and instead sell Shire's brand name NDA product as "Authorized Generics." When TEVA/Actavis merged, Prasco picked up TEVA's distribution deal with Shire and **NOT TEVA's ADDERALL XR ANDA**. When those distribution rights expired, Prasco then made a new deal directly with Shire to continue to distribute the NDA product as an Authorized Generic. Prasco never had an ANDA and has only sold Shire's NDA product. Meanwhile, TEVA started selling a true generic version of Adderall XR using the Actavis ANDA, and they continue to do that without interruption.
Clear as mud. TEVA's ANDA is officially discontinued, but it was never used. TEVA continues to make a true generic Adderall XR with the Actavis ANDA. Prasco has never manufactured anything, and they never had anything to do with any ANDA for Adderall XR.
Why all the misinformation from this broker? This is not a cannabis play
I have no idea if Generex is now or ever was truly developing any cannabis products. They have a habit of chasing shiny objects and signing letters of intent. Whether they were or were not, they certainly SAID they were. Starting in 2015, Generex started hyping cannabis just like every other penny stock. I've never seen any public statements from Joe disavowing all their previous PR's on the subject. If somebody wants to ask why some European brokerage just now decided to stick it to them five years after the fact, then that is a reasonable question. But it strains credulity for them or anyone to try to say now that they weren't at least pretending to be a cannabis player 2015-2019. My suspicion is RapidMist cannabis project is long dead for multiple reasons. I have the endorsement on my medical license that allows me to prescribe medical marijuana, and I can tell you not one patient has ever said to me that what the dispensaries really need is some remarkably-average Canadian weed in a really expensive dispenser that works kinda okay. The oral tinctures work great for buccal absorption without the RapidMist inhaler. Plus, we understand THC metabolism a lot better than we did in 2015. Buccal absorption was considered very promising because it avoids the "first pass metabolism" through the liver, which degrades the THC by 70-80% before it is distributed to the brain. This can be measured, and THC degradation pharmacokinetic curves can be drawn which will make a stoner cry. BUT! Stoners, chill! Science to the rescue. We understand now that some of the metabolite products from THC's first pass metabolism are just as psychoactive as THC. There are more of them, and they cross the blood-brain barrier more readily than the Momma THC molecule. So it may take longer to get high, but there is usually an enhanced and prolonged psychoactive effect from oral absorption compared with buccal absorption. Long story short, buccal absorption of THC is not as big a deal as we thought it would be, and even if it was, tinctures work just fine without RapidMist technology. I never paid any attention to CBD soft drink nonsense, so I have no idea what they're up to with that, but Generex most definitely did claim to be a cannabis play, in multiple ways, and has never said otherwise. I'm sorry that is causing problems now, but denying reality has not been working out well lately, so let's confront the truth for a change.
Generex Announces Issuance of Buccal Cannabis White Paper NEWS PROVIDED BY
Generex Biotechnology Corporation Oct 01, 2015, 09:30 ET
WORCESTER, Mass. and TORONTO, Oct. 1, 2015 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today announced the issuance of a white paper on the use of cannabis for medicinal purposes and the joint venture between Generex and CannScience Innovations Inc. (www.cannsci.com) for the design and development of products for the delivery of cannabinoids and cannabinoid-derived formulations into the human body via the buccal mucosa (the inner lining of the mouth).
The white paper is authored by Dr. Lakshmi P. Kotra, B. Pharm. (Hons), Ph.D. and Dr. Angelica M. Bello. Dr. Kotra is the Director at the Center for Molecular Design and Preformulations (CMDP) at University Health Network (UHN) in Toronto, Canada, a scientist and principal investigator at UHN, and an Associate Professor of Medicinal Chemistry at the Leslie Dan Faculty of Pharmacy, University of Toronto (www.uhnresearch.ca/kotralab). Dr. Bello is a scientific associate at UHN.
The white paper may be viewed online on the Generex website.
Generex Announces NuGenerex HydroHealth CBD High Alkaline Health Water As First Target Product In Planned Line Of CBD Therapies
November 26, 2018 09:00 AM Eastern Standard Time MIRAMAR, Fla.--(BUSINESS WIRE)--Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (www.otcmarkets.com/stock/GNBT/quote) today announced an agreement with Puration, Inc. (USOTC: PURA) to develop and produce NuGenerex CBD HydroHealth High Alkaline Water. The CBD used in the NuGenerex CBD HydroHealth product line will be exclusively derived from industrial hemp using a patented extraction process that yields ultra-purified and characterized CBD formulations.
....
“Subject to testing and corresponding regulatory approvals, we’re targeting a million-bottle launch of Generex CBD HydroHealth Water in 2019,” said Joseph Moscato, Generex President & Chief Executive Officer. “Given the network of pharmacies Generex owns itself, we are confident we can achieve if not exceed our million-bottle launch target. Puration’s experience and the caliber of Puration’s underlying extraction technology combined with the recently updated production facilities of Puration’s co-packer, are instrumental in Generex’s plan to rapidly launch NuGenerex CBD HydroHealth Water.”
“We are especially excited about Puration’s patented extraction technology that enables us to explicitly define and characterize the CBD and cannabinoid content of hemp extracts to develop proprietary, patented formulations for NuGenerex,” said Jason Terrell, MD, Chief Medical and Scientific Officer of Generex. “Through NuGenerex Distribution Solutions, we have the consumer connections, technology, and HIPAA compliant systems that will enable us to compile real world evidence on the safety and effectiveness of our NuGenerex CBD products for health maintenance in a variety of chronic conditions.”
Generex Announces New $11 Million Collaboration on Buccal Cannabis
NEWS PROVIDED BY Generex Biotechnology Corporation Apr 23, 2015, 09:45 ET
Generex to receive $10M in common stock, a warrant, & $1M in R&D funding
WORCESTER, Mass. and TORONTO, April 23, 2015 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) today announced that it has entered into a non-binding Letter of Intent (LOI) to license the Generex proprietary RapidMist™ drug delivery technologies to Smoofi, Inc. (www.smoofi.com) (OTCQB: SMFI) for the delivery of medicinal and recreational cannabis derived products into the bloodstream through the buccal membrane.
The Generex RapidMist™ drug delivery platform administers medications directly into the mouth as a metered dose spray for rapid absorption by the buccal mucosa. Generex's most advanced product in development using RapidMist™ is Generex Oral-lyn™, an insulin spray product for the treatment of diabetes mellitus.
SMFI is a provider of consulting and advisory services to licensed medical and recreational marijuana operators and retail dispensaries within the United States. SMFI guides clients through the "seed to retail" process, beginning with business planning, competitive strategy and technology, regulatory compliance and local permitting, site selection, setup and financing.
In exchange for the grant of the global license (excluding Canada), SMFI will issue to Generex (a) $10,000,000 worth of SMFI common stock, and (b) a warrant to acquire up to 15,000,000 shares of SMFI common stock. SMFI will be obliged to qualify the common stock, including the common stock underlying the warrant, for public distribution. The per share strike price of the warrant will be determined based on the average closing price of the SMFI common stock on the OTCQB for the 10 trading days immediately preceding the effective date of the qualifying registration statement. If that price is equal to or less than $3.00, the strike price will be $1.30. If that price is greater than $3.00, the strike price will be equal to 43.34% of that reference price.
SMFI will be solely responsible for the costs associated with the research and development of buccal cannabis products. SMFI will also be solely responsible for the regulatory endeavors associated with such products in its territory as well as the manufacturing, marketing, distribution, and sale of such products in its territory. SMFI will pay to Generex a royalty equal to 20% of SMFI's net revenues from the sale of such products in its territory.
The previously announced buccal cannabis co-development arrangement between Generex and CannScience Innovations Inc. has been revised. Under the revised arrangement, (a) Generex will grant to CannScience a license for the commercialization of buccal cannabis products in Canada in exchange for royalty equal to 15% of Canadian net revenues from product sales, (b) Generex and CannScience will undertake the research and development of buccal cannabis products for SMFI and CannScience, and (c) Generex will remit to CannScience 50% of any royalty payments paid to Generex by SMFI. SMFI will provide initial R&D funding of $1,000,000.
CannScience (www.cannsci.com) is an R&D biopharmaceutical company established in Toronto, Canada to conduct research and product development for formulations and extracts related to medical cannabis and its derivatives. CannScience is developing proprietary technologies and owns know-how related to the chemistry and pharmacology of cannabinoids and potentially how they integrate with various medical devices and drug delivery technologies.
Generex, SMFI, and CannScience believe that absorption of cannabis derived products through the buccal membrane offers distinct advantages to alternative routes of administration – principally, a faster onset of activity compared to oral administration, higher level of control for dosing, and more predictable absorption and pharmacodynamics.
The discussions between Generex, SMFI, and CannScience are at an early stage, and the LOI does not assure that SMFI or CannScience will enter into licenses with Generex or utilize the RapidMist™ technologies. Even if Generex, SMFI, and CannScience enter into formal license arrangements, any benefit from those arrangements will depend upon the abilities of Generex and CannScience to develop products, and of SMFI and CannScience to have such products approved by the appropriate regulators, and successfully commercialize them.
About Generex Biotechnology Corporation
Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency, while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
About Smoofi, Inc.
Smoofi, Inc. is a provider of consulting and advisory services to licensed medical and recreational marijuana operators and retail dispensaries within the United States. Smoofi guides clients through the "seed to retail" process, beginning with business planning, competitive strategy and technology, regulatory compliance and local permitting, site selection, setup and financing. Smoofi will provide a wide variety of industry education and training including business process optimization and how to scale growth. The practice also includes operational assistance with cannabis cultivation, offering expertise in modern farming techniques, utilizing new technology and conservation methods to improve quality and yield, waste reduction and maximizing profit. For retail clients, the Smoofi consulting practice assists with the design of retail locations, staffing, loss prevention techniques, marketing and community outreach. For more information please visit: www.smoofi.com.
Last Friday the international clearing house that works for my Dutch broker BinckBank, gave Generex a cannabis related indication. This means that my broker no longer allows any trading in Generex. We all know this indication is incorrect, so I wonder why it was given.
I think the actual issue here is your broker does not understand that collaborations with Generex are where good products go to die.
Scientus Pharma Provides Update on Buccal Cannabis Development Program TORONTO, Oct. 31, 2018 (GLOBE NEWSWIRE
...
“The RapidMist Buccal Delivery System from Generex is perfectly suited to the formulation and administration of cannabinoids for therapeutic benefit,” said Joe Moscato, CEO of Generex. “THC and CBD ratios can be formulated specifically for therapeutic indications to achieve optimal benefit, and the device provides a consistent, reliable metered dose to ensure proper use. Patients will be satisfied with the ease of use and reliability of effect of the RapidMist Cannabis product line.”
About the Scientus Pharma/Generex Collaboration
In September 2015, CannScience Innovations Inc., one of Scientus’ predecessor companies, finalized a binding co-development and technology licensing agreement with Generex. Pursuant to the agreement, Generex has licensed its proprietary RapidMist™ drug delivery platform technologies to Scientus for the co-development of products for the buccal delivery of cannabinoids and cannabinoid-derived products. Generex has also granted Scientus an exclusive, worldwide license to commercialize such products in exchange for royalty payments. Generex and Scientus will co-own the intellectual property created by the co-development effort.
Quote: ********** Did Teva DISCONTINUE Adderall XR? **********
Before I count my chickens, I would wonder why is Teva getting out of a billion dollar business? It is probably not because they think it will cause them to have too many chickens. If Teva doesn't want those chickens, why the hell not? Damn demon zombie chickens, for all I know.
Elite's former CEO Jerry Treppel on SUICIDE WATCH.
Owns 404,019 shares of Akorn.
Investment went from $21,740,262 to $76,763
21 million to 76 thousand!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Ouch. He may need to discuss a new plan with his financial advisor. He is going to regret selling those ELTP shares a few years ago. My best wishes to Jerry. I think he served Elite well. It seems like the FDA warning letters to Akorn were less of a cause and more of an excuse for Fresenius to back out of the deal. The generics market shifted, and Fresenius had irreversible buyer's remorse before Akorn could close. Ultimately, it's not their death knell. I might have been overly dramatic when I said, "Debt. Downturn. Done." But it sounded better than "Debt. Downturn. Debt restructure." And Jerry might need to add another "D" -- DIVERSIFY.
May 21, 2020 06:17 AM UPDATED 2 HOURS AGO Akorn files for bankruptcy after failed takeover, FDA warnings The Lake Forest-based drugmaker listed as much as $10 billion of debt and $10 billion of assets in its Chapter 11 petition.
This is not a stock I follow regularly, but it is a stock I have seen mentioned on this board several times. It has a similar aspirational story as ELTP, small pharma, multiple decades of R&D, move to generics, OTC origins. Almost made it. OTC--> NASDAQ. Premium $4.3B buyout offer by Fresenius in 2017. And just like that -POOF- it all fell apart.
In December of 2018, Fresenius SE backed out of its $4.3 billion offer for the company after it discovered issues with Akorn’s pharmaceutical production, quality control and drug testing. Then, in 2019, the FDA issued warning letters to Akorn relating to two of its plants—one in Somerset, N.J. and the other in Decatur, Ill.—after finding manufacturing violations.
From OTC penny stock to $49 on NASDAQ just 5 years ago, now back to 0.17 today. Debt. Downturn. Done. A cautionary tale.
Here are the voting rules for the Special Shareholder Meeting:
For = For Against = Against Abstain = Against Not voting = For
Ball is in your court...
I'm feeling very conflicted about the shareholder vote by mail. I understand the coronavirus pandemic means it would be unsafe to have an in-person vote, but My President says mailed ballots are "fraudulent in many cases." He said, "Mail ballots are a very dangerous thing for this country," and, "People cheat. There's a lot of dishonesty going along with mail-in voting." He tweeted about mail-in ballots, saying they are "'RIPE for FRAUD,' and shouldn’t be allowed!" He said mailed ballots are "corrupt" and "a terrible thing."
My President says voting by mail is corrupt, but My President voted by mail in the Florida primary election. What should I do? How can I resolve this conflict about voting by mail in the upcoming shareholder election? Should I do as My President says, or should I do what My President does?
We are highly specific Th1 T cell and B cell activation toward portions of SARS-CoV-2 proteins for which their is very good evidence of protection. No one else has this. Everyone else is doing sub unit vaccines, for which there is very good evidence that portions of those sub units trigger disease enhancement.
In molecular biology terms, this would be referred to as "gibberish."
NuGenerex Diagnostics using peptides to develop a rapid test for 2019-nCOV in respiratory and blood samples using its proprietary NGDx Express II rapid diagnostic technology
Lord knows I haven't kept up with all of the PR coming out of this company, but I try to pay special attention for updates on the COVID-19 diagnostic test. Clicking the COVID link on the main page of the website does not even mention it. Have I missed something since Feb 6? All the updates seem to be about the peptide vaccine from NGIO, which has great potential, but what about the diagnostic test? This is right in the NGDx wheelhouse. Developing rapid, reliable diagnostic tests for emerging infectious diseases is kind of their thing. My primary care office is able to offer COVID testing for our patients as of today, but I don't know of any other office in the area that has COVID testing, including the big hospital-owned practices. We received 10 test kits today, which is an accomplishment, but not the important part. The test kit is literally a cotton swab, sterile tube, and a bio-hazard bag. The tech is in the lab. The real trick is having someone who will come pick up the test kit and process the swab, which we do, but I'm afraid I can't reveal how the trick is being performed. We'll just say a big bird took us under their wing. The simple ability to offer a COVID test to our patients is a great relief, but we only cover a few hundred people. It is extremely problematic that these tests are not more widely available, especially as we prepare to reopen society. We are encouraging our patients to stay low for the foreseeable future. A strong test from NGDx would be a huge benefit to humanity (and might even make a few bucks).
Public companies are strongly encouraged to return funds if they did receive any. Elite will not benefit at all. Anything else is a fabrication.
I hope the companies who get the help are the ones who really need it and not those who simply find it to be a convenient business opportunity. I paid attention to JJ's post earlier about potential shutdowns. I think it is inevitable that just about every facility will go through something like this, probably even multiple times. Maybe routine processes will need to slow down for safety. This is not going to be over any time soon, and our solitary factory is at the epicenter of the global outbreak. Every company can expect delays, slowdowns, and shutdowns for many months to come. If a company can continue operations without government money, then I think they should leave it alone.
And if that's not good enough, then I would remind everyone of the last time Elite Pharma dipped their hands in the government honeypot, in the form of NJ bonds. It was damn near their ruination, and the bonds were the direct cause of "going concern" language for years to come.
Everybody agrees that abstaining from the vote was perfect. They say, "Sir, the way you didn't vote was perfect. We've never seen a more perfect non-vote." Not a lot of people know this, but not voting is an option. They think you have to check one box or the other box, but really, you don't have to check either box, and it's perfect. Not a lot of people know that. You don't have to check a box- that is fake news. The media will say you have to check this box. The CEO will say you have to check that box. But you don't have to check any box, and it's perfect. Not a lot of people know that.
but that all begs the question why even worry about it at this point.
This is not a nothing burger. The company would not be going through the expense, trouble, and embarrassment of redoing the vote for no reason. Let me give my take on why what happened is a real legal liability and why the vote must be redone.
I did not vote my 2.35 million shares. I strongly believe not voting is a vote, especially when the results of an election are a fore-drawn conclusion. Declining to participate in a pre-ordained election is a statement. Shareholders were specifically informed by the company that if no instructions were provided then no vote would be recorded, and that was my intention. But apparently it did not happen that way. It seems very unlikely that my 2.35 million "non-votes" are recorded in the 3.75 million absentiontions. It looks like somebody voted my shares in the affirmative. I could wait until Nasrat converts, merger proposal, whatever I wanted to wait for, then start a shareholder lawsuit. It would not be difficult to find an attorney or prove what happened to my 2.35 million non-votes, as well as everyone else in the class action. Maybe nothing would happen in the end, but it would definitely delay things and scare away suitors. It would be a disaster, and I'm just the kind of prick to do something like that. So, please, let's dispense with the idea that the company is going through this humiliating and expensive process out of an abundance of caution. They are doing this because they screwed up in an unfair, unjustifiable way that has very serious implications for the future of the company. They have to fix it, no other choice.
I see we launched Adderall XR. I am very pleased and look forward to all the future revenue. I hope to see the next SunGen filing soon. I added 150K shares ELTP last week. I call this tranche the "Finish The Basement" tranche, which I hope to do in the next year. I don't want to seem impatient, but sharing the TV with my teenage children is becoming an issue, so let's get this show on the road to Dollarland.
Was told that they are finding COVID-19 does not just do respiratory damage
COVID-19 spike protein requires cleavage by human furin enzyme, which is fairly ubiquitously made in cells across virtually every system. Although we think of it mainly as a respiratory disease, it is important to pay attention to all kinds of symptoms. People with diarrhea as the first symptom tend to present later in the course of infection and have worse outcomes. The virus is definitely able to replicate in the G.I. tract. It also seems to have systemic effects which remind me of severe sepsis with ARDS then MSOF, which is probably mediated by a cytokine storm. Obviously, age and pre-conditions like coronary artery disease, diabetes, and hypertension are important risk factors, but there is some combination of X factors that occasionally causes an otherwise healthy young doctor or nurse to crump & die. Genetics? Viral dose? Meds? Virus sub-strain? The good news is that the furin binding site on the spike protein presents an obvious target for drug therapy. Block that site and you block activation/infection.
Spike proteins are what coronaviruses use to bind to the membrane of the human cells that they infect. The binding process is activated by certain cell enzymes.
SARS-CoV-2, however, has a specific structure that allows it to bind “at least 10 times more tightly than the corresponding spike protein of [SARS-CoV] to their common host cell receptor.”
Partly, this is due to the fact that the spike protein contains a site that recognizes and becomes activated by an enzyme called furin.
Furin is a host-cell enzyme in various human organs, such as the liver, the lungs, and the small intestines. The fact that this enzyme resides in all of these human tissues means that the virus can potentially attack several organs at once.
There is currently an enormous shortage of testing. Work in pharma and so far no testing for us either.
The cuts in funding have obviously taken a toll. Now seeing the impact.
Heading out to Lowes. No Menard's available. Will see what I can get.
The test we did on Monday came back on Wednesday. The test we did on Tuesday is still not back. No masks are showing up on any shelves any more, not even 1-2 at a time. My assisted living group pulled more than #400 N95's from 4 different Menard's over 1 week, but the whole chain is now on indefinite back order and any future supplies from them will be cash & carry only. I put my group in contact with a guy, and they made a deal for #55 N95 masks for $700 plus shipping. The only thing left in the stores now is discontinued items that are no longer in their computer but got tucked away in up-shelf stock. You just have to know what to look for. I was like a ninja yesterday. I pulled #12 P95 and #24 R95 from a HD and a Lowe's yesterday. (P95>R95>N95, if you can find one.) I'm a damned grown man, but when I opened those boxes, it was like Christmas 1980 and those were Atari's inside. Check the upper shelves of your local stores for these older, discontinued life savers.
Dear Joe,
I don't want to put any pressure on you, but if you could significantly flatten the curve by having your subsidiary pump out about a billion 15 minute rapid assays until your other subsidiary can make an effective vaccine, we would all really appreciate it. Thanks!
Current test kits are running 3-4 hours. If we had a 15 test kit for Covid 19, it would fly.
I currently have no way of ordering CV-19 testing. Our local hospital ran a drive thru testing line using Cleveland Clinic's test on Monday and Tuesday, and it closed today due to "lack of resources". We got our office manager through the line on Monday, but she still doesn't have results. She has been sequestered all week. I am advising my patients with symptoms to self-sequester for 2 weeks, and I drop off an N95 mask in their mailbox to try to protect their families.** I consult for an assisted living organization with more than two dozen facilities across the state. They have essentially unlimited resources, and they are highly motivated not to have any of their buildings become a "hot spot." I have advised them when the resources are available to test every resident and every employee at least 1x/week in an effort to avoid asymptomatic spread. So far we have found one contractor willing to test our employees just one time, and that's it. These guys have done every single thing I've told them to do, and I have no doubt they would be buying 3,000 tests per week indefinitely- if they could.
**My daily rounds now include two different Lowe's and a Menard's store. No medical supply companies have any N95 masks, but we are slowly acquiring them 1, 2, if we're lucky, 30 at a time at the home improvement stores. I occasionally find an N100 at Lowes, which are awesome, but Menard's is more likely to have some N95 five-packs. I went through the Menard's line six times the other day (limit of 6/person).
Good luck to all during these crazy times, stay on the down-low and stay safe. Find an N95.
I do not recall any "really good news" that has ever moved this stock, as far as the daily PR's go.
Okay, well now I can think of one time good news caused this stock to move. Obviously, this PR is different. For one thing, it's nice to see an actual contract for a change, instead of another imminently doomed letter of intent, and it's nice to see some actual dollars changing hands, too. But that is not what I mean. I suspect those of you who have been around for a while, like me, take particular satisfaction in today's actions. The old guard like us bought this stock years ago because of the Ii-Key technology, among other things. I, for one, have never lost faith in Antigen Express or its ability to create highly-immunogenic peptides. The Ii-Key-COVID-19 peptide vaccine is for real. Antigen Express is for real, and real scientists run it. This will be a very effective vaccine, and it should be available early, maybe even the first construct to start human trials.**
**Note: this statement applies to every future outbreak and pandemic.
I'm a molecular biology nerd. I don't give a crap about surgical equipment or pharmacies. The only thing I know about an MSO is that they screw up my billing all the time. I do not invest in companies that do those sorts of things. I invest in companies that have technology to make really good vaccines really quickly. I am looking forward to seeing what Antigen Express can do as a stand alone company. I hope this positive blip for GNBT does not cause a delay in the delivery of our sweet baby. Joe, if you love it, set it free...
Emmaus has PDUFA date this summer, but they are not publicly-traded, so there is no opportunity to see their enterprise value increase if the drug is approved. Solution: merge with a publicly-traded company- ASAP. Enter Generex, a publicly-traded company desperate for a quick pop in share price so that a long-planned reverse split can finally take place.
This is akin to a shotgun wedding. Young sweet Emmaus has found herself pregnant and set to deliver this summer. She really needs a ride. She's desperate to get married, and at this point she doesn't much care to whom. Here comes Generex, the ugliest, smelliest guy in town. He has no money, but he has a crappy car and lots of big plans. What the hell she figures- I gotta do something. So she makes him brush his damn teeth and get a haircut and gets him looking half decent. He says Let's get married! And she says Yes! But first give me 1.5 million dollars, and he says You got it baby. Will you take a check?
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