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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.
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.
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.
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.)
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.
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.
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.
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.
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.
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.
From OTC penny stock to $49 on NASDAQ just 5 years ago, now back to 0.17 today. Debt. Downturn. Done. A cautionary tale.
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?
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).
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.
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.
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.
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!
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.
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...
* This stock only went to $18 immediately after the announcement of a 20:1 forward split**. It immediately fell back after the split. I do not recall any "really good news" that has ever moved this stock, as far as the daily PR's go. The only thing that has moved this stock is artificial manipulation through announcements about dividends and splits.
** 20:1 forward split was preceded by 1000:1 reverse split.
I usually do not have the chance to listen to these calls, but I did today. I heard the CEO say in no uncertain terms that this company is being severely limited by over-regulation from the DEA of quota for methamphetamine API. I thought it was interesting that he specifically mentioned the current administration as the cause. In previous calls, he was confident that he could launch Adderall XR in just a few weeks because he knew he would have quota of API available from Adderall IR. But what he said today is that he could have sold even more IR by now if he had more quota. He cited the DEA's stinginess with API quota as the cause of any ongoing Adderall shortages.
In my opinion, Nasrat's refusal to provide any forward guidance has everything to do with his uncertainty about getting quota from the DEA. Whether by policy or lack of competent administration, the DEA has its regulatory boot on the neck of this company. Who is in charge of these Big Government thugs?
Selling hydromorphone (Dilaudid) ANDA to Nostrum is not surprising. That fits very neatly with selling off the Percocet and Norco ANDA's. But while methadone is technically a generic opioid, it is more frequently used as a maintenance drug to treat opioid addicts. There is no reason to get out of the methadone business, so not sure why this is happening now.
Phendimetrazine is not an opioid. It is an appetite suppressant. It is a CNS stimulant, so I wonder if it might be going over to Lannett with the other CNS stimulants. I doubt that Nasrat has a buyer for phendimetrazine. The reason is because Elite actually has **TWO** ANDAS's for the same drug: phendimetrazine 35mg tablets (ANDA's #040762 & #203600). Elite already had an ANDA when the supposed "merger" with Micah brought in the second ANDA. Nasrat could have sold one phendimetrazine ANDA at any time in the last 5 years and still kept one for the pipeline. Elite also holds **TWO** ANDA's for a different CNS stimulant appetite suppressant called phentermine (15mg + 30mg capsules vs. 37.5mg tablets). Lannett already sells the phentermine capsules but not the tablet.
Hopefully we will get some clarification of the strategy on the conference call.
I guess we can forget about the oxycodone patent suit with Purdue. I wonder if any of those attorneys know anything about class action shareholder cases. Maybe they could help out with that lawsuit instead, or whatever is coming down the pike.
FDA has repeatedly made the point that Aximris is significantly easier to manipulate than OxyContin. Specialized equipment was required to mill OxyContin for snorting, but the same task was easily accomplished for Aximris by using common household equipment. This would be especially concerning since snorting Aximris results in a nearly 70% increase in plasma oxycodone levels compared with oxyIR, which has no abuse deterrent features at all. What a turkey.
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.
Mission accomplished. No need for me to attend this AdCom. I don't think this drug brings much that is new to the table to either prevent abuse or attract prescribers, but without the untested, poisonous blue dye in the formula, I no longer believe it represents a severe safety risk to unsuspecting consumers.
If I were Intelli, I would have Dr. Odidi wave and smile from his seat while keeping his mouth shut. Whoever presents for the company, every answer to every question should be some version of either, "No food effect, unlike Xtampza" -or- "No dose-dumping with alcohol, unlike OxyContin." Those are the only two benefits of this drug over what is already available, and FDA has repeatedly said it will not approve any new opioid that is not as good as or better than what is currently available. Since Xtampza has the chewing abuse deterrent label, if FDA approves this drug without the chewing label, then they would be going against their own guidance. It will all come down to the chewing and snorting HAL studies. We should get a sneak peek at the data on Monday, as well as FDA's attitude about this meeting. In my experience, these meetings go the way the FDA wants them to go, and this is often apparent in the advance documents.
Pay close attention to the advance documents, and act accordingly. GLTA.