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Please provide link for this.
Quote:
Nasrat agreed to hold his preferred shares for 3 years and those 3 years are just now up .....
Item 1.01 Entry into a Material Definitive Agreement.
On February 7, 2014, Elite Pharmaceuticals, Inc. (the “Company”) and Elite Laboratories, Inc., its wholly-owned subsidiary, amended the
following convertible promissory notes: (i) an August 1, 2013 Secured Convertible Note to Mikah Pharma LLC (“Mikah”) due August 1, 2016
in the principal amount of $10,000,000 (the “Mikah Note”), and (ii) a November 21, 2013 Convertible Note to Jerry Treppel due November 21,
2016 in the principal amount of $600,000 (the “Treppel Note” and, together with the Mika Note, the “Notes”). Mikah is owned by the
Company’s CEO and President and Mr. Treppel is a director of the Company. Generally, the Notes were amended to make them convertible
into shares of the Company’s newly created Series I Convertible Preferred Stock. For a description of this new series of preferred stock, please
see “Item 5.03” below. The Mikah Note also was amended to make it immediately exercisable.
Not the voting rights.
but I have no idea if the right would transfer to the converted common shares or to a new owner.
Both; nasRAT (Mikah Pharma LLC) now holds the voting rights and who ever buys Mikah Pharma will then hold control of them but a form 4 will be required to show the transfer.
• the surrender for transfer of any certificates for Common Stock or convertible Preferred Stock outstanding will also constitute the surrender for transfer of the Rights associated with the Common Stock or convertible Preferred Stock represented by such certificates.
Preferred shares have full voting rights.
The Series I Preferred Shares are described at the below filing. Nasrat always had full voting rights for his preferred shares, so that is not a reason to convert. Also, I believe the Treppel note was converted to Preferred, and he still holds those, although many fewer. The Shareholder Rights Agreement specifically includes the Preferred shares, but I have no idea if the right would transfer to the converted common shares or to a new owner. 15% ownership without a board-approved deal would trigger the Shareholder Rights Agreement, and Mikah currently holds more than 15% outstanding and may, by now, hold more than 15% of authorized.
http://www.edgarexplorer.com/EFX_dll/EdgarPro.dll?FetchFilingConvPDF1?SessionID=7ZPSeSgJdJaMo-9&ID=9758559
Section 3. Voting Rights . The Holders of shares of Series I Preferred Stock shall have the following voting rights:
(a) On any matter presented to the stockholders of the Corporation for their action or consideration at any meeting of
stockholders of the Corporation (or by written consent of stockholders in lieu of meeting), the Holder shall be entitled to cast the number of
votes equal to the number of whole shares of Common Stock into which the shares of Series I Preferred Stock held by the Holder are
convertible as of the record date for determining the stockholders entitled to vote on such matter.
What’s in a name?
What's Mikah spelled backwards "doc" WeeZuhl?
Always has been a shell company for the generics within.
Which one of these two will happen Monday morning before the bell?
1. Humanwell Healthcare Group and PuraCap Pharmaceutical announce acquisition of Elite Pharmaceuticals.
2. Humanwell Healthcare Group and PuraCap Pharmaceutical announce partnership with Elite Pharmaceuticals.
Explanation of Responses:
( 1) The preferred shares are convertible into shares of common stock at a rate of 1,428,571.43 shares of common stock for each whole share of preferred stock.
( 2) The securities are held by Mikah Pharma LLC. Nasrat Hakim is the sole beneficial owner of Mikah Pharma LLC.
( 3) None
Uh, okay.
These Epic directors were the private owners of Epic. They are the ones receiving the $550 mil from PuraCap. Therefore the monies used to buy $ELTP warrants to shares and options to shares are all interlinked to Epic thru these private owners. That is why Epic Pharma and Epic Investment dispersed all of the $ELTP shares etc to its private owners at no cost.
Folks need to do their own DD research.
lasers
Saturday, 08/20/16 08:45:48 AM
Post # 222741 of 222870
Especially so since PuraCap owns ALL of Epic's acquired $ELTP shares.
File Attachment:
Correspondent Name: Mr. XXXXXXXXXXXX
Create Date: 2015-05-17 19:20:24
Origin: Web
File #: HO::~00495440~::HO
Description:
Nasrat Hakim became CEO of Elite Pharmaceuticals in August 2013. In November 2014, he began receiving disbursements of shares of ELTP stock from Epic Investments, which is an arm of Epic Pharmaceuticals, a strategic partner of Elite. He has received disbursements of ELTP stock from Epic on multiple occasions, including disbursements to his IRA and to a separate entity he controls, Mikah Pharmaceuticals. There has never been any public disclosure of Nasrat Hakim's relationship with Epic Investments. I have queried Investor Relations and was only told that Nasrat Hakim was a member of Epic Investments prior to becoming CEO of Elite. If this is true, then this should have been disclosed at the time. Likewise, he did not disclose any indirect ownership of Elite through Epic Investments on his initial SEC filings. And if he was always a member of Epic Investments, then why did he not receive any disbursements until Novemeber 2014? I believe that he became a member of Epic Investments sometime after he became CEO of Elite and before November 2014. I believe that no matter what his relationship with Epic and when it started, the details of the relationship should be publicly disclosed. Epic and Elite are very closely related. Members of Epic hold substantial shares in Elite, and Epic's CEO and Executive VP are both Elite Directors. Epic executive Ram Potti is a former Elite Director. There is no way for Nasrat Hakim to be a member of Epic Investments without it being material information to Elite Shareholders. Either he failed to disclose the relationship when he became Elite CEO or he failed to disclose it when he became a member of Epic while CEO of Elite. Either way, he needs to disclose to the exact nature of his relationship with Epic to Elite shareholders.
I was not aware of this.
Especially so since PuraCap owns ALL of Epic's acquired $ELTP shares.
Freedom of Information Act Request to FDA
It is impossible to make this long story into a short explanation, nor is that my tendency. I was trying to answer a series of questions, and in the process I found an interesting document with redacted information that may be relevant to the SequestOx Tmax issue. I have filed a Freedom of Information Act Request for the redacted information via the FDA’s web portal. I’ll update here whether or not I get any new information from the FDA, and I’ll share anything I learn with the company.
I was first trying to define the goal-posts for immediate-release oxycodone fed Tmax (high calorie). The official label for Roxicodone tablets and all generic tablets (ANDA’s referencing the original Roxicodone NDA) use the exact same biopharmaceutical data in their official label. It looks like this:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202662Orig1s000lbl.pdf
Hmmm, I say. Why do oxycodone tablets show the Tmax for the oral solution? When you trace the data back to the original NDA, it very clearly states: “The food effect for the to-be marketed tablets can be extrapolated from the food effect on IR solution.” The tablets and solution were bioequivalent in the fasting state, but the tablets were not tested in the fed state. If the original Roxicodone tablets were never tested for fed bioequivalence, were any of the currently-marketed generic tablets tested for BE after a high-calorie meal? Does the FDA even know the fed Tmax data for the array of available tablets?
Does it make a difference? Is the fed Tmax different for the tablet vs. solution? After all, the brand name for the solution is OxyFast- maybe it really is faster. Isn’t that why abusers chew (or also “parachute”) their oxyIR/Percs/Norco- for faster absorption and quicker high. Maybe the fed Tmax of “Roxicodone tablets” isn’t as tidy as the FDA thinks, and maybe SequestOx is being unfairly judged against oral solution. Since Nasrat has never released the data, the controls used in ELI-200 studies are unknown. We know it was a three-way crossover (that sounds hot!) but not if any control formulations were tested in the fed state. “Three-way crossover” sounds to me like #1 Roxicodone fasting, #2 SequestOx fasting, and #3 SequestOx fed. This means that SequestOx failed to be bioequivalent to FDA data and not to an oxycodone “fed control” group run in crossover with ELI-200. In other words, SequestOx did not fail head-to-head, instead it failed against what the FDA deems to be the proper fed Tmax. This is very important, especially if the FDA data on fed Tmax is as sketchy as it seems.
Next I started trying to track down the fed Tmax for oxycodone tablets, and it turns out that it is not public information, as far as I can find. But! I did find the fed Tmax for oxycodone capsules! I don’t understand the full history of how this happened, but somehow along the way a bunch of generic manufacturers started making oxycodone 5mg in capsule form and oxycodone solution with a different manufacturing technique. They were doing this without proper approvals and the FDA swept them all off the shelf at once, similar to what they did to us with Lodrane. Lehigh Valley (with Glenmark Pharmaceuticals) subsequently received approval for their two products via 505b2 NDA’s for a 5mg capsule- and a second NDA for oral solution. Both NDA’s use Roxicodone as a reference product. The approval documents for these NDA’s contain the fed Tmax data for the capsules, and the official label for the capsule (and every generic oxy 5mg capsule ANDA based on Lehigh Valley’s capsule NDA) refers to the data from this NDA application, and it looks like this:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200534s000lbl.pdf
This is massively important in multiple ways. First off, this proves that there is a significant difference between the fed Tmax of oral solution compared with capsules. After a high-fat meal, oral solution Tmax increases from 1.25 to 2.5 hours (200%), while the capsule Tmax increases from 1 hour to 3 hours (300%). There is no question that after a high-calorie meal, the excipients in the solid capsule affect the Tmax more than the excipients in the liquid solution. Which Tmax is SequestOx supposed to meet for bioequivalence? Liquid or solid? 200% or 300%? Does it meet neither? Nasrat knows.
Second, based on the capsule’s 3 hour fed Tmax, there is almost definitely a path forward for SequestOx. As long as SequestOx fed Tmax is within 3 hours 45 minutes (125% of 3 hours), then it is bioequivalent to the Lehigh Valley capsule NDA. All that should be required is to change the reference drug to Lehigh Valley’s oxycodone capsule NDA. (Important note: the Lehigh Valley NDA is only for 5mg capsules, so ELTP would likely have to ditch everything except 5mg. But 5mg represents a large majority of the scripts.) Fun thought: **IF** the fed Tmax for SequestOx is less than 3 hours 45 minutes, then SequestOx 5mg should be immediately approved as bioequivalent to Lehigh Valley oxycodone capsules.
The savvy Tmax aficionados among you probably noticed that if the Lehigh Valley capsules fed Tmax increased by 300% then it is NOT bioequivalent with Roxicodone reference drug (200%). Despite this, the capsules are listed as bioequivalent to Roxicodone in the FDA’s Orange Book (code “AB”= “Meets necessary bioequivalence requirements”). Likewise, the capsule’s T max delay is not considered a safety issue, and the capsules do not have any food-effect warnings or instructions to take on an empty stomach. There are multiple reasons why FDA may choose to approve a drug which is outside of bioequivalence range. For instance, these capsules had previously been sold on the market before being removed, and the dose size is diminutive- an extra 5mg capsule is much less dangerous than an extra 15mg or 30mg capsule. The reasons for approval, which are highly relevant to SequestOx, are generally discussed in the Summary Review. Clearly there were “multiple formulation changes” in the process, but multiple areas of discussion in the Summary Review are redacted. The Summary Review for Lehigh Valley NDA is signed by Dr. Sharon Hertz:
Avridi used oxycodone tablets as a control, but all of their Tmax data is reported as median and not mean, so it is apples to oranges. I went back and calculated the means based on some of their graphs. This is kind of like putting a T-bone through a meat grinder and then trying to put it back together as a steak. It certainly was not pretty, but it fed a hungry man. The data is very, very rough, but basically shows the oxycodone tablet mean Tmax going from 1 hour fasted to 1.8 hours fed (median was 1.5 hours) and Avridi mean Tmax going from 1 hour to 5.1 hours (median was 4.5 hours). I believe reporting the median instead of mean artificially diminished the Tmax delay for both oxycodone tablets and Avridi. Avridi’s Tmax delay is probably even worse than it appears, but this sketchy data does not indicate a major difference in fed Tmax between the oxycodone tablets and the published data for oxycodone oral solution. Remember, Avridi has detergent-based ADF, so the major high-fat food effect makes sense. SequestOx is a standard capsule and should act more similar to Lehigh Valley generic capsules and less like Avridi, but for now, only Nasrat & Eugene know for sure.
It is possible ELTP already has access to fed Tmax data for oxycodone tablets, since Elite formulated the Epic oxycodone ANDA. If fed bioequivalence was performed, Nasrat has the data. We know definitely capsules are slower than solution, and while not proven, it seems logical that fed Tmax of tablets will fall somewhere in between. What it seems to me, though, is that SequestOx capsules have been judged against oral solution, and it is doubtful that any oxycodone capsules have ever or will ever approach a similar fed Tmax to oxycodone solution.
SUMMARY
1. Original Roxicodone tablets were never tested (or at least never reported) under high-calorie fed conditions.
2. Every oxycodone tablet sold in U.S. carries a label that reports the food effect data (Tmax) of oral solution instead of tablet. It is unknown how many, if any, of the currently-marketed generic tablets were tested for bioequivalence after high-calorie meal. Many times ANDA applications are granted “in vivo waivers,” meaning their bioequivalence is assumed based on “in vitro” biochemical analysis.
3. Currently-approved oxycodone 5mg capsules have significantly slower Tmax compared with oral solution- double the Tmax effect and well-outside of the range of bioequivalence with oral solution. These capsules are not considered to have a food effect and do not carry instructions to take on an empty stomach.
4. Currently-approved oxycodone 5mg capsules have Tmax after high-cal meal of 3 hours. Bioequivalence standards require SequestOx to be within 125%, or 3 hours 45 minutes. If SequestOx fed Tmax is equal to or less than 3 hours 45 minutes, then it is already bioequivalent to Lehigh Valley NDA #200-534 and could be immediately approved in 5mg size if RLD is changed.
5. Lehigh Valley Pharmaceticals received Approval for oxycodone 5mg capsules, despite significantly delayed fed Tmax, without any food-effect labeling or safety concerns. The commentary which may explain why this was allowed has been redacted from the NDA’s Summary Review, which is signed by FDA’s Dr. Sharon Hertz. A Freedom of Information Act Request has been submitted by me for the redacted discussion.
6. While there is a significant difference in the effect of a high calorie meal on Tmax of oxycodone solution compared with capsules, there is no published data regarding the fed Tmax of tablets. In a three-way crossover pivotal BE study, it is unlikely SequestOx had any “fed control” arm with tablets. Nasrat likely has access to tablet fed Tmax data because of Elite’s work on Epic’s oxycodone tablet ANDA. This may be the kind of information he is collecting to show FDA.
7. Avridi used oxycodone tablets as a fed control, but the data is reported as “median” instead of “mean,” so it is not comparable to published data. Extrapolation suggests the mean is slower than the reported median for both Avridi and oxycodone tablets, but it was not suggestive of major Tmax difference between oxycodone tablets and solution. Based on my guesstimation, if Avridi reported fed Tmax as “mean” instead of “median”, it would look even worse, greater than 5 hours (and therefore outside the bioequivalence range of even the Lehigh Valley capsules). Avridi has detergent ADF, but SequestOx does not.
WeeZuhl: Are you still in?
The 180 is amazing....... good work.
Another great post? Whatever you say............
Another great post. Well-reasoned.
NOW, if we do find a way to fix the Tmax issue on SequestOx then that is a whole different story.
True that.
How about the A Team could have filed the ANDA for percocet 3 years ago but the A Team did not know any better and the FDA told Elite Percorcet was already considers abuse proof. How much money was wasted on those clinical trials?
Great catch, ama. Nice post.
I love your brand of DD. You should come around more often.
Dear WeeZuhl,
I suffer from malusdomesticaphobia. What happens if my doctor prescribes SequestOx?
Signed,
In Fear of Fujis
Even when I try to be nice...
So just like that you now believe this is BS?
After calling it zombie sequestox?
This is not evidence-based medicine.
So it is that, what Weezhul suggests can offer a simple fix to the problem…or an Occam’s Razor. Remember, the simplest explanation is often the best. So it is with fixing problems. I am no scientist or medical expert, but I recognize from basic statistics that to reformulate is asking for a totally new trial. Simple is best and Eugene is the guy to make the argument. Here is Weezhul’s Occam’s Razor (also known as the Law of Parsimony)…that we should hope is the basis for Eugene's argument to the FDA that is well established and often appears on prescription labels in one form or another...
SequestOx should be taken on an empty stomach. Taking less than 2 hours after eating may delay the effect. NEVER TAKE MORE THAN ONE PILL IN FOUR HOURS
Patient Characteristics and Outcomes in
Unintentional, Non-fatal Prescription Opioid
Overdoses: A Systematic Review
Pain Physician 2016; 19:215-228 • ISSN 1533-3159
Conclusion
Opioid overdose morbidity is significantly more
prevalent than mortality, and sequelae of toxic events
should be studied in more detail. Increased risk of morbidity
occurs with: (i) increased opioid availability in
the community, (ii) increased dosage, (iii) use of methadone,
(iv) nonmedical use, dependence, and illicit drug
use, (v) aberrant behaviors, (vi) past suicide attempt,
(vii) decreased or lower tolerance, (viii) lack of education,
(ix) middle age, (x) poverty, (xi) presence of mental
health disorders, (xii) medical comorbidities, and (xiii)
co-ingestants. Although abuse-deterrent formulations
have been approved, there is no overdose-safe prescription
opioid available to date. Opioid overdose morbidity
and mortality is seen across the entire spectrum of
patient use with significant numbers of adverse events
occurring in population segments not identified by
high risk indicators. Increased physician awareness of
this epidemic as well as additional education on lifethreatening
opioid-induced respiratory depression that
can occur in any patient using opioids as opposed to
patients suspected of suffering from an opioid use disorder,
as well as the availability of take-home naloxone
could help mitigate the overdose epidemic while maintaining
effective pain control for patients.
Eugene was hired well after the NDA filing
Elite Announces U.S. FDA Priority Review Designation For SequestOx™ NDA
SequestOx™ NDA Submission Accepted for Review
NORTHVALE, N.J., March 17, 2016
Elite Pharmaceuticals Announces Changes To Their Board Of Directors
Gene Pfeifer Joins Elite's Board
NORTHVALE, N.J., April 12, 2016
The one true expert, indeed.
SequestOx has no bearing on the other drugs. It is, in fact, a stand alone. Nasrat speaks for the company regardless of your personal feelings. That makes him the expert on Elite drugs.
Paul Hudson writing in Elite Daily says:
“Being a CEO or in a position of true power requires certain skills and abilities that psychopaths exhibit with ease. Making objective, clinical decisions entirely void of emotion, planning meticulously and in great detail, being patient, restless and confident, having a need to be in control… are all characteristics that psychopaths and prominent leaders share.”
These findings tallied with other research linking psychopathy with CEO’s and leaders of the corporate world. Research has shown that in the general population, around 1% of people meet the classification for a psychopath, but among industry leaders the figure is 4 times higher.
Sorry you missed it...
Interesting phrase considering your loss of composure this week.
I'll play along though. How can an IR drug have any effect or kill off the ER version? Did you not hear Nasrat say the problem has nothing to do with the upcoming drug applications? He seemed to also be referring to the other IR drugs.
In my argument, SequestOx was never just a stand-alone product but was always going to be a lead-in and ambassador for the entire ADF line-up. This what I mean when I say Zombie SequestOx* will infect our entire pipeline. All those SAFETY QUESTIONED concerns may not be sequestered to just Zombie SequestOx*.
You're totally right, dude.
This is absurd nonsense. SequestOx has no bearing on the rest of the pipeline.
Quote:
KILL ZOMBIE SEQUESTOX* BEFORE IT KILLS OUR ENTIRE PIPELINE.
"We don't roll over and play dead. We solve them and move on."
This isn't even a major obstacle. What would you do if you face a serious obstacle?
Couch, Eugene has a very strong ally.
Now I do believe this double standard is why Eugene Pfeiffer was hired. If you can put on a label take one hour before or two hours after and sprinkle during meal otherwise.....that seems to be a pretty safe label to me
Good Afternoon, Couch
I think we are going to have to explain how Egalet's Oxyado which has the same TMax problem was approved?
I do agree that knowing the TMax level/range would help further the discussion here.
Seems to me a label insert in this fashion takes care of the problem....making SequestOx far from a zombie drug as Elite's ADT is far superior to any IR Oxy on the market.
Thanks for asking.
Your opinion has also opened my eyes. Are you out of ELTP or do you feel they can dig themselves out of this mess? Appreciate your view.
You misunderstand.
No one is questioning his integrity. At all.
But to claim this has been dead since 2014 and yet he has been here for how many years. (Before 2014) why now all of a sudden make it seem like he knew this was DOA.
Bottom line is that SequestOx, except for IR Oxy, is completely different than Avridi.
Senderos read my posts since Monday morning
Weezuhl: you seem to be singing a different tune than you have been singing for weeks re SequestOx. Did you sell and now want to buy back cheaply? SequestOx is now dead? Come on. Fess up.
Avridi drug liking curve
Anybody think the awesomeness of our abuse deterrence will compell the FDA to approve SequestOx? Look at Avridi's IV abuse drug liking curve. It's the best I've ever seen, better than SequestOx (sorry about the cross study comparison, doc, I figured you wouldn't mind in this case). It is so good it makes me feel tingly in private places. Aversive, effective, durable.
And here's why it was rejected. It is not bioequivalent to oxyIR under fed conditions.
Anybody believe that Big Pharma did this to us? Avridi is a Purdue drug. Who did it to them? Face it people, SequestOx is a Zombie Drug dead since 2014. Kill it off now before it gets on the bus and bites the rest of our pipeline with its bullshit label instructions. Stop wasting time & money on this inferior product. Reformulating the oxy bead and repeating the pivotal bioequivalence is the only viable answer.
Fool me once, shame on you...
I say let's trust Nasrat and the team. They know a hell of a lot more than everyone on ihub combined times a lot.
Camargo is exactly who I blame.
All of this... and please Mr Wee Zhul do not blame Camargo... this is on the FDA.
The bioequivalence studies for these opioid abuse deterrent products are being conducted under the direction of Camargo Pharmaceutical Services.
09.11.2015
FDA Panels Nix Avridi Reformulation
Panelists say safety concerns outweigh benefits of abuse-deterrent, immediate-release oxycodone
WASHINGTON -- In a joint meeting of two FDA advisory committees, panelists voted 23 to 1 against approval of Purdue Pharma's immediate-release oxycodone (Avridi).
Panelists' main concern was that the drug's requirement to be taken on an empty stomach would be too complicated for patients to manage -- and if it wasn't followed precisely, it could lead to an increased risk of adverse effects, including overdose.
"The problem here is that they have developed something with a beneficial abuse-deterrence property, but the product is inferior to the one on the market from the standpoint of how it will work in the most common patient population that needs it," said panelist Sharon Walsh, PhD, of the University of Kentucky.
"It might give providers a false sense of safety because it has a label of abuse-deterrence, but in reality it adds a safety concern," said advisory committee chairperson Almut Winterstein, RPh, PhD, of the University of Florida.
You will be, John.
But I was told to buy all I could below 35¢ and I would be the first OTC millionaire.
Also, I'm really, really mad at Nasrat.
But I'm not going to ask for my class ring back.
Dead Drug Walking. Kill Zombie SequestOx.
“The extent of the delay in the absorption and peak concentration of oxycodone from SequestOx under the fed conditions is unacceptable”.
FDA-Approved Embeda Sauce
"ALTERNATIVELY EMBEDA MAY BE SPRINKLED ON APPLE SAUCE"
Now, there's a great idea.
ELTP... can change the thickness of the coating around each bead per strength of the drug (5,10,15,20,30 mg,etc) to make Cmax and Tmax coincide.
Except, of course, our referenced product
ALL IR opioids have the same 1 to 3 hrs delays if taken with a meal. ALL IR opioid takers know this from experience.
I'll wait to hear what the FDA says...
I would think that if he felt he had to rely on 'magic' for the study to pass that he wouldn't waste the $$ on it. If this were Elite's only drug I would think he may do it because he has no other alternatives. But given those $$ could go to studies for ER drugs I think he must feel there is a reasonable chance the additional study will improve the Tmax number.
I know it was you, John
Should I lower my 2¢ bid?
Tmax could be FAR off
Could TMax really be that far off if we were BE on AUC and CMax?