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Let's say that this ends up being the average wholesale cost of a bottle of #100 isradipine from Elite, even though I doubt it will. And let's say just 50,000 of the 1 million PD patients in U.S. (5%) take isradipine manufactured by Elite.
5% of U.S. Parkinson's patients
50,000 x 2 tabs/d = 100,000 tabs/d = 1,000 bottles /day 1000 x 365 = 365,000 bottles/y 365,000 x $179.83 = $ 65,637,950 /year
I also got a few PM's re: this issue of how many competitors for generic Percocet. Unfortunately, it is impossible for me to answer this question. The reason is because it would require me to give a crap, which I don't. Just start making that shit and sell it cheap. Generic success is all about price. The lower the price, the more clicks by pharmacy buyers.
Percocet approval marks an important transition for Elite. There are many competitors for Percocet because it is a big-selling drug. All of ELTP's currently-approved ANDA's are niche products with only a few competitors. Hopefully, there will be a handful more big drug ANDA approvals to follow in the next few years, but currently, they have nothing else like it in the portfolio. So, Percocet is an important test for Nasrat and team. They have our factory ready. They have our first big drug approval. Now what can they do?
How many competitors? Don't care. How competitive? That's the question.
I retract my previous opinion and associate myself with Amigo Mike's explanation from the dark web. He is consistently correct on these structure & finance issues. Amigo Mike, why do you treat us this way and make us go looking all over the internet for your informed opinions? The great unwashed need your gospel. Thank you.
They sold 6.6 million warrants for enough cash to get them through the reverse split. The good news is that if the share price doesn't go above .60 then there won't be any more dilution. The bad news is that this will not get them to NASDAQ compliance, and the real dilution will come after the reverse split.
No mention of how much cash they got for 6.6 million warrants or to whom they sold them. In typical IPCI fashion, they are treating their shareholders like mushrooms- keeping them in the dark and feeding them shit.
Nasrat doesn't get a paycheck. He gets paid with restricted shares. Still pure dilution, no doubt, but not through LPC. He gets a fancy certificate, and then he pays cash out of pocket to IRS for income tax. He has lived off savings for past 4 years. He has never taken $1 cash out of company; in fact, he loaned cash to the company. As the son of a steelworker, I tend to think all CEO's are overpaid, including this one, but at $1 million, his salary and bonus is commensurate with other pharma CEO's. I think it means something important that Nasrat has traded his whole life's work for shares of ELTP. By far the largest shareholder, he continues to work for shares today. Shareholder value means more to him than anyone.
That list is proof of nothing. That's just a list of brand names. Most of those are long since d/c'ed. Too funny. I'm not even the one who said anything about Europe.
Facts do matter. Thanks for the link. I'll wait for individual links to all the European countries who are not in European Union: Albania, Armenia. Belarus, Gibraltar, Iceland, Kosovo, Lechtenstein, Macedonia, Norway, Russian Federation, Switzerland, Turkey, Ukraine, and Vatican City State (Holy See). Also, too, I wasn't the one who brought up Europe. There are at least a few other continents, last I checked. I guarantee there are Parkinson's patients in all of them.
I never said anything about Europe. But it is a fact that brand name DynaCirc was sold world-wide, under several names, but all of the brands were discontinued long ago. I'm certain there are many countries where isradipine is no longer available or never was, maybe even some in Europe. Lots of countries give quicker approvals if products are already FDA-approved. Canada is a good example of both.
Prevalence of Parkinson's Disease is similar throughout the world, but availability of isradipine is not. Ten million patients. We have a factory. We own the recipe. We can get the API. We have Doug Plassche. We can make more.
Nasrat's baby coming home in October. It is already manufactured at the Northvale plant, which is a GMP-certified and DEA-registered facility. I have acquired a fair share of ownership in both the factory and the isradipine ANDA. Makes me proud to think that something I own could provide substantial benefit to hundreds of thousands of people. No reason why we couldn't help millions of people worldwide.
Their ANDA number is 5,521 lower than ours. FDA received 1,306 ANDA applications in FY2017. This suggests Epic filed their ANDA considerably sooner than Elite, possibly several years before. It is very possible this was a co-development project as Elite originally intended to submit their version as a 505b2 NDA with sequestered naltrexone.
$23 million from NIH just to fund the isradipine Phase 3. Millions more from NIH and MJFF for pre-clinicals and Phase 2. Massive public spending on behalf of PD patients and to the benefit of Elite shareholders. Close to half the market cap of the company spent but not a dime from ELTP treasury. Amazing.
This is exactly what we needed. Just wait and see. FDA Approvals are like whizzing at the ballpark. You may go five innings before the first one, but then it’s like every inning after that. Who cares how many competitors, fire up the factory. Bring on Norco! Bring on methadone! Free the hostage Mikah drugs now!
Dumping the methadone contract manufacturing was a contrived and smart move by Elite. When the ELTP methadone ANDA gets approved, produced, and marketed by Glenmark, then the revenues will be back and significantly better than ever. *poof*
It is conjectured that isradipine's unique ability to cross the blood-brain barrier is why it is the CCB with the greatest neuro-protective effect in Parkinson's. Pretty slick. Can you imagine the cost of the STEADY-PD Phase 3 trial, a large 3 year study conducted in 50 research centers? And also the Phase 2 before that? Ten million dollars easy. Twenty five maybe? More? What a great benefit to Elite shareholders to have these trials funded by the NIH and Michael J. Fox Foundation.
It's a little more complicated than that. Elite could file a Prior Approval Supplement to their isradipine ANDA and get FDA approval to market the drug for the new indication (P.D.) with a new brand name (and presumably new price). Theoretically, they could market a brand name version for P.D. and continue to sell generic isradipine, too. Docs would prescribe the brand if there was a good reason, such as a first month "Starter Pack," which would be a bubble pack that uses 2.5mg tablets to titrate up the dose over 4 weeks to the study dose of 5mg 2x/day. Since isradipine is a strong BP drug, they used a ramp-up dosing regimen like this in the STEADY-PDIII trial and achieved excellent participant retention. Not only could they charge more for a brand name starter pack, it would actually be a cool thing that would be helpful and increase safety. I would think the FDA would be receptive to that kind of marketing proposal.
I bet Glenmark will also get isradipine when we bring it home in October. We already manufacture it at the Northvale plant, and Glenmark will have it plugged in and ready when STEADY-PDIII results are published in early 2019. Many expect this Phase 3 trial will show isradipine is effective to slow down progression of Parkinson's Disease, and with a million patients and only one competitor, Elite will need a high-caliber partner like Glenmark.
It doesn't. PODRAS doesn't do anything at all until the 3rd tablet. This is why it doesn't prevent oral abuse. I've posted the graphs and the photos from the PODRAS patent multiple times. Look it up. Also, remember, PODRAS has to work exactly right every time, or it is useless. And I don't mean it has to prevent overdose every time. I mean every time a legit user takes a legit dose, PODRAS has to work exactly right. The antacid layer has to be completely destroyed then acid-releasing layer has to be completely uncoated before the tablet passes into the small bowel where the pH is too high to trigger the release. If it doesn't, then the legit user gets none of legit dose. For oxy, that means acute withdrawal with nausea, vomiting, and acute pain for starters. For other meds, it could be even worse (seizures? death?). This is a very tall order considering the common variation in stomach acid can vary by 1000X. Some people take strong acid-inhibiting meds. Some people take meds with empty stomach (fast transit) and some people take meds with full fatty meals (slower transit but higher pH). That's why it will never pass a bioequivalence study for any drug and probably why it hasn't made even 1 small step in development in more than 3 years.
The PR announcing Fast Track designation for PODRAS is dated May 26, 2015. More than 3 years ago. In more than 3 years, this super awesome global game changing pure gold everybody will want this for every drug technology has not been advanced ***AT ALL***. In more than 3 years, no partners. In more than 3 years, no proof of concept studies. In more than 3 years, no bioequivalence studies. Exactly how game changing can it be if, in more than 3 years, there hasn't been one single positive step in development. It's not like they were too busy doing HAL studies. Let's just say it is highly unlikely that the shareholder vote scheduled 41 days before NASDAQ delisting has anything to do with PODRAS. I know this because I know PODRAS is a grift. Even if it works as intended, which it won't, it doesn't prevent abuse and doesn't prevent suicide. At best, PODRAS is a very expensive, very finicky replacement for a 5 cent childproof cap. Let's all hope that whatever is up their sleeve, it is way more developed and way more real than PODRAS. 100% Vaporware.
I'm not sure if this is going to go well for our competitor, PTIE. The FDA has been suggesting for at least two years now they would not likely approve a new product that is less abuse deterrent than an existing product. That means something different for new product NDA's vs generic product ANDA's. Currently, there are no approved generic ADF's. The FDA guidance is that any generic will have to be at least as abuse-deterrent as the brand name product. For example, generic OxyContin ANDA applicants will be required to have snorting and IV abuse ADF labels but not oral/chewing ADF label, because OxyContin does not have that label. I suspect that may be what is holding up any generic OxyContin approval among the handful of sponsors who have beaten Purdue in court. This is less clear cut for an NDA applicant, and the FDA guidance language is intentionally vague. The usual understanding, however, is that FDA will not approve a new product if there is a comparable product that is more abuse deterrent. Collegium's Xtampza sets the standard on this now, since it proudly wears all three ADF labels. When Xtampza got the chewing label, I believe it became an uphill battle for any 12 hour oxy ER product that does not qualify for all 3 ADF labels. There definitely is some wiggle room, and, as we all know, FDA doesn't throw an AdComm party if they've already typed up the CRL. But this is the exact kind of issue that the Advisors on the committee will "bulldog." They're going to clamp down on this lack of an oral abuse deterrence claim and they'll chew it up relentlessly for hours before they spit out the mangled mess.
I still think they'll announce a 10:1 reverse split, but I'll concede the way it is rolling out, it could be anything, including some crazy scenarios. If I were to engage in untethered speculation, it would make sense to come up with some deal to resolve the UBS situation to the satisfaction of all parties. Some kind of buyback/preferred share scenario that requires shareholder approval for some reason. Envision multiple buyers with enough cash to move the dial over $1, maybe with a little help from some kind of positive result. IMO, any solution that avoids a reverse split is entirely dependent on Mr. Patient's abilities and connections. Good luck to him and everyone.
That's it? I wouldn't have any confidence at all that the language in Article 6 of the company bylaws gives them the ability to do a reverse split without shareholder approval, especially when there seems to be national/provincial law that is much more specific:
Can you cite your source for that? It seems much more likely a shareholder vote would be required for a reverse split than for a PODRAS announcement. Same with partnership- just do it. And why would Boyd allow for the May 2018 BOD vote without saying a peep but then demand a special meeting 3 months later in order to get a seat? It's not UBS- they want out, not in.
wimike, the market cap is irrelevant. Remember, there is an easy exception to the $35 million market cap requirement. All they need is $2.5 million in the bank. Recall in March when they avoided a delisting notice by raising $3.5 and $1.8 million, but by April they were broke again and back out of compliance. That's when they got the delisting notice. There are actually 3 ways to maintain compliance, but they all require $1 share price. So, unless they have something else up their sleeve, a reverse split followed by a big cash raise does adequately serve the purpose of maintaining NASDAQ listing. Really, the question is not whether there will be a RS. The better question is will the RS be 5:1, 10:1, or 20:1?
I think 5:1 is definitely out because it doesn't give enough buffer for the price to fall any further. The question of 10:1 vs 20:1 is entirely dependent on what UBS plans to do with their unwanted 7 million shares. In the past, UBS has been required by settlements with SEC and various states to repurchase Auction Rate Securities (ARS) from their clients at par value. If this is a similar arrangement, UBS not only owns 7 million shares of IPCI they never wanted, but they paid multiple dollars per share. Their 7M shares probably cost them more than the current market cap of the company. This is a big bank- how patient will they be with Dr. Odidi before they write this off as a total loss and dump those 7M shares on the open market? I shudder to think of it. If UBS dumps, then a 20:1 reverse split may not be enough.
The IPCI Shareholder Meeting in August might look more like Carrie's prom.
Acetaminophen might be considered a mild deterrent to snorting, but generic Percocet and generic Norco are definitely *NOT* considered ADF's by anyone anywhere anytime.
I have good reason to believe the results will show at least a modest benefit for isradipine. This is a high-quality, prospective study over *3 years.* Very rare to see this long of a study, and this one is designed to pick up even a small benefit of 25% reduction in disability over 3 years. Also, there were several checkpoints where interim data was analyzed for futility. If there was no benefit at all, the study would have been halted. So we know that the drug is well-tolerated because the participant retention rate is very high, and we know the drug is not futile because the study was not halted. And don't forget free. I like free.
Hey tedk10, great sticky post at the top, btw. You're looking for the fda orange book. It's got a new look and functionality recently, and I haven't explored much. This is where you can find all the NDAs and ANDAs for various drugs, including patent info, exclusivity, etc. As an example, let's look up my current favorite sleeper candidate for 2019 ELTP Drug of the Year. Go to the orange book and type 'isradipine', and this is what you see:
Very interesting. Glaxo is completely out, with both of the brand name products, DynaCirc and DynaCirc CR, marked as "Discontinued." Likewise, Mylan's generic is d/c'ed. That leaves Teva and Elite as the only two U.S. manufacturers. So, tedk10, you say- who cares? You say isradipine is the redheaded stepchild of the calcium channel blocker family- always living in the shadow of his more successful and handsomer older brother, Norvasc (amlodipine). Harsh, ted. Although it is true that total yearly sales of isradipine have been around $5 million for a long while, the situation may be changing soon. STEADY-PDIII is a very important Phase 3 study of isradipine in Parkinson's Disease, which afflicts more than a million Americans. The last patient will complete the 36 month observation period in November 2018, and final results are due in early 2019. There is great hope the results may prove at least a modest benefit of isradipine for slowing down progression of Parkinson's Disease, and some expect the results will show significant benefit.
A few important points. First, this is a specific effect of isradipine. Other CCB's do not seem to have a similar effect. It was first noticed that people who took isradipine for blood pressure were less likely to develop Parkinson's, and the effect was further substantiated with epidemiological and animal studies. There was a Phase 2 safety study that showed good tolerance of the middle dose: isradipine 5mg twice daily. Both the Phase 2 and Phase 3 studies were funded by the NIH, so it is kind of awesome that this old drug with only 2 competitors is being treated like a brand new novel drug. Elite stands to gain huge benefit if the results are good- without spending a penny. And the greatest part is that if the results are good, neurologists and PCP's will immediately start prescribing the drug, which is already approved and on the market. No waiting for the FDA on this one. If there is even a modest effect, we can expect 100's of thousands of new patients will be started on isradipine. If the effect is substantial, I would think we will see a majority of the million+ PD patients in the U.S. started on isradipine. And, it will happen basically overnight.
If isradipine becomes a major drug for Elite, it will be 100% thanks to Nasrat. First, it is a Mikah drug. But even beyond that, this drug has been Nasrat's baby. It was the only drug of the 12 that were contracted with Epic that he took back from them. He let 10 of the 12 sit on the shelf, but isradipine he took back. He brought Doug Plassche over in good part because Doug was familiar with isradipine manufacturing. Even then, it was quite an ordeal to get it out the door. Quite a lot of trouble for a $5 million dollar drug, so no doubt, Nasrat understood the significance of this one old drug, certainly above all the other Mikah drugs. He made sure this drug got on the shelf, and if STEADY-PDIII results are good, Elite will do very well. Nasrat will deserve all of the credit.
Great job this week, N2K. Multiple strong posts both days, fighting the good fight. I know what it means when I see significant increases in the frequency and audacity of misinformation. It means there is no ammunition based in truth. It means there is desperation triggered by the company's progress. Two awesome PR's back-to-back last week caused a frowny frenzy this week. Great job clearing up the confusion.
The SunGen and Glenmark PR's complement each other perfectly. Glenmark will allow Elite's drugs to gain more market share sooner, including future SunGen drugs, and maybe older Mikah drugs coming back from Epic. I especially like that neither of last week's PR's were about ADF opioids. Lately it feels like having the best ADF tech is like having the prize-winning rhubarb pie at the county fair. You get a blue ribbon same as the others, but apple and cherry get the real glory. I still believe that requiring IR opioids to have a quality ADF, like ELTP's 2 bead antagonist tech, is one of the few things we could do as a nation to help staunch the epidemic of opioid addiction in young people, but I do not see any evidence it will happen soon. SequestOx is an important drug that will fill an unmet need of critical importance, but with fluctuating trends in opioid prescribing and uncertain penetration of ADF’s, it is important to insulate the company by diversifying the pipeline. Whatever happens with opioids and ADF's, SunGen and Glenmark guarantee our factory will be busy. With these agreements, Nasrat is effectively setting the table and shaping the future of the company.
Interesting. We've discussed Glenmark before. They were the ones who sponsored Lehigh Valley Pharma efforts to get an NDA for oxycodone 5mg capsules via the 505b2 pathway. Small world, eh? (Or maybe not.)
ELTP 2 bead antagonist ADF patents are all about the antagonist bead. The patents barely mention the agonist bead. For SequestOx, the reformulation was the agonist bead, which IMO should have no effect on patent protection.
Ha! "Prove it" is exactly what I have done. I proved it in multiple ways over many days, and I gave plenty of links and screen shots along the way. When I make a claim, I come ready to back it up. No twitty crap like DO YOUR OWN DD!! – not from me. No whining that You Can’t Prove A Negative. I took on an ihub legend, and I took it down. I slayed the beast by proving it doesn’t exist. Nobody shorts ELTP. I proved it! I proved it can’t be done from a U.S. account. I proved offshore brokerages require cash deposits in order to short a penny stock, usually $2.50/share. I proved offshore brokerages charge daily risk fees- 365 days per year- higher risk, higher fees. I proved repatriation of profits would result in additional taxes. I explained how regular buys and sells are reported as short sales on the daily FINRA reports seen on otcshortreport.com, and why it is not a reliable indicator of short sales. I explained how market makers use short sales to provide liquidity to markets, and how it is a part of their mandate and why it is good for retail investors. I explained how the bimonthly FINRA report is a much more accurate measure of market maker short sales, and how it shows a miniscule percentage of short sales which are at historic lows over multiple decades. I linked to the bimonthly SEC Failure To Deliver reports, and I explained how they show no evidence of any significant amount of naked shorting. Most importantly, in this case, the absence of evidence is the most convincing evidence of absence. I’ve been popping off about this for many months, and I’ve challenged the whole internet to post evidence of shorting ELTP. Not one person has said Yes, I short ELTP and here is an example of how I did it, and here is a screenshot and here are the results. Not one. (Unsubstantiated claims supported only by specious demands to DO YOUR OWN DD!! are immediately ignored and dismissed as usual ihub hot air.)
Nobody shorts ELTP. I proved it, over and over and over again.
Earlier post we were shorting for a quick 4% gain, in and out, trying to ameliorate risk. Now this post we're shorting it and staying short for months waiting for a CRL. Which is it? Even the biggest pessimist would admit that there are any number of news events that would double this stock price. There are a few that would send it straight to a dollar+. There is no calculation that makes shorting a 9 cent stock make any sense. Feel free to prove me wrong. I won't hold my breath.