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So what? And also, no.
Those shares are registered shares and marked accordingly. None of those shares can be sold until de-registered approval is given by the $ELTP BOD. This act is a Material Event and requires a SEC filing by $ELTP BOD. De-registering of Restricted shares has previously been discussed on this MB.
There are assets here worth acquiring...
1. Buccal drug delivery platform.
----A. "OraLyn" for insulin
----B. "RapidMist" for marijuana, etc.
2. Ii-key immune system activation tag for vaccination, "Antigen Express".
----A. AE-37 (promising data in difficult to treat "triple negative" breast cancer).
----B. Applicable for rapid vaccine development for influenza, Ebola, etc.
Generex with Mark Fletcher as CEO will never, ever make anything of any of these assets, but the assets are nonetheless real, promising, patented, and deserving of ongoing development. Fletcher may be an incompetent CEO, but he does own a lot of shares. My hope is that Fletcher's desire for Personal Enrichment will result in some sort of deal for these assets prior to BK instead of after BK. If not, then why bother to issue an "Annual" Report? Wasn't it intersting that there was a spike in volume on Friday even though the report was not filed until after market close? Somebody acquired 10 million shares between .005 and .008 last year (including some of mine). Somebody knows something. I'm not buying this turd, but I do have decent stash of bagholder shares that I'm willing to hold as an all or nothing speculative bet. Buyer (holder) beware.
https://www.ncbi.nlm.nih.gov/pubmed/27029708
In patients with triple-negative breast cancer (HER2 IHC 1+/2+ and hormone receptor negative) DFS was 77.7% in vaccinated patients (n = 25) versus 49.0% in control patients (n = 25) (P = 0.12).
Maybe, maybe not.
As an addendum, there has been No insider selling.
"Annual" Report
http://ih.advfn.com/p.php?pid=nmona&article=73614064&symbol=GNBT
Page 2:
Preliminary Note
As of October, 2015, (the first quarter of fiscal 2016), we laid off all of our employees, and ceased compensating our officers, and suspended substantially all of our operations due to lack of funds. The description below related to our historical business. If we do not receive substantial financing, we will need to completely shut down our operations.
On December 27, 2016, the Company filed a Certificate of Amendment to effect a reverse stock split. Upon approval by the Financial Industry Regulatory Authority (“FINRA”), each 1,000 shares of the Company’s common stock issued and outstanding at the effective time shall automatically be combined into one issued, fully paid and non-assessable share of common stock. This potential reverse stock-split has not been reflected in the share or per share amounts disclosed in these consolidated financial statements.
FDA confirms Egalet's story.
http://www.medpagetoday.com/neurology/generalneurology/62441
An FDA spokesperson told MedPage Today that MorphaBond, another morphine product, has "marketing exclusivity for labeling describing the expected reduction of abuse of single-entity, extended-release morphine by the intranasal route due to physicochemical properties."
FDA confirms Egalet's story.
http://www.medpagetoday.com/neurology/generalneurology/62441
An FDA spokesperson told MedPage Today that MorphaBond, another morphine product, has "marketing exclusivity for labeling describing the expected reduction of abuse of single-entity, extended-release morphine by the intranasal route due to physicochemical properties."
They do.
Pfizer has no leg to stand on regarding patent rights regarding formulation. Clearly they do on exclusivity rights but only regarding Troxyca. Pfizer has no exclusivity rights regarding Embeda whatsoever any longer to my knowledge.
I agree with every word of this.
$ELTP's IP Lawyers BAKER & HOSTETLER LL, which are also one of the very best Litigation firms, will slam any and all frivolous claims by Purdue/Pfizer. $ELTP two-bead technology is "Night and Day" different than Purdue's one-bead hot melt extruder tech.
BAKER & HOSTETLER LL has planned the SequestOx litigation strategy from day one that Nasrat Hakim has become CEO.
It could be Purdue AND Pfizer.
You do realize Pfizer pays Purdue royalty fees for Embeda patent infringement rights don't you???
Pfizer isn't going to sue Elite - it doesn't have a leg to stand on. If anyone is going to sue Elite it is going to be Purdue.......but here's the funniest part..........Teva and Epic pharma screwed Purdue - LMAO!!!
Nobody is going to pull one over on Elite - Purdue's main ADT patents were ruled to be invalid.
So BS on the whole Elite will be tied up in court for years.
Besides Elite hired the previous FDA lead attorney. Good luck on that legal front. LMAO!!!
It could be Pfizer's legal strategy vs Elite
I do find it very bizarre that Troxyca has not launched yet.
Somebody definitely knows something...and its not good!!
Does anyone know what our current TMax delay time is with sequestox? I know the currently approved roxicodone one is as follows
"Food Effect: A single-dose food effect study was conducted in normal volunteers using the 5 mg/5 mL solution. The concurrent intake of a high fat meal was shown to enhance the extent (27% increase in AUC), but not the rate of oxycodone absorption from the oral solution (see Table 1). In addition, food caused a delay in Tmax (1.25 to 2.54 hour). Similar effects of food are expected with the 15 mg and 30 mg tablets."
So if Elite can come within comparable measures to 1.25-2.5 hours then we should be good.
What about immediate-release such as SequestOx ???????????????????
ELTP 2 bead antagonist ADF tech will easily qualify for IV, snorting, and chewing ADF label for every opioid agonist with any time-release characteristic. No known company is within 10 years of marketing an effective overdose ADF.
jour, the terminology is fuzzy
The phrase "oral abuse" is commonly used to refer to chewing and also commonly used to refer to swallowing extra whole pills. There is no official nomenclature at this point. It creates a lot of confusion because those are obviously separate components of abuse deterrent technology. I wish FDA and company literature would use more specific language, such as "chewing" and "overdose."
ELTP 2 bead antagonist ADF tech will easily qualify for IV, snorting, and chewing ADF label for every opioid agonist with any time-release characteristic. No known company is within 10 years of marketing an effective overdose ADF.
Not quite.
Think about it, nobody wants the liability, if you had a choice of prescribing 1 of several different options, as a doctor, you go with the safest bet....
ADF Label is no joke.
Mon Jan 9, 2017 | 5:39pm EST
Egalet painkiller wins FDA approval but label disappoints
By Toni Clarke
The U.S. Food and Drug Administration on Monday approved Egalet Corp's long-acting opioid painkiller, Arymo ER, and will allow the company to claim it deters abuse by those seeking to dissolve and inject it.
However, investors had hoped the company would also be allowed to claim the drug deters abuse by those seeking to snort or chew it. That did not happen, and the company's shares fell 5 percent to $8.00 after the market closed.
This is an important point, tedk10.
238 million in insider shares and we have 905 million outstanding
roughly 26% insider holding
Is Embeda working, solving this problem?
‘You can’t put a price tag on anybody’s life’
Two years after the overdose that killed her 21-year-old son, Terri Bartlett traveled to Illinois’ state capital to champion an unlikely cause: revamped painkillers.
Bartlett’s son Michael became hooked on Vicodin and later graduated to heroin. In emotional testimony last year, she urged lawmakers to support a bill that would prioritize the new harder-to-crush pills, saying she believed her son would still be alive if abuse-deterrent formulations had been on the market then.
“You can’t put a price tag on anybody’s life,” she said.
Bartlett didn’t know then that she had been recruited into a wide-ranging lobbying campaign. A public relations firm hired by OxyContin-maker Purdue had helped recruit her to support the bill, along with local sheriffs and fire chiefs.
Her words, and similar testimony from parents of drug abusers elsewhere, reflect a tactic used by the drugmakers across the country. For instance, Purdue paid nearly $95,000 for similar lobbying efforts in New York, state records show.
And the industry’s fingerprints are easy to spot in other areas. Of more than 100 bills dealing with the drugs introduced in 35 states in 2015 and 2016, at least 49 featured nearly identical language requiring insurers to cover abuse-deterrent drugs, according to an analysis of data from Quorum, a legislative tracking service. Several of the bill sponsors said they received the wording from pharmaceutical lobbyists.
New York Gov. Andrew Cuomo and New Jersey Gov. Chris Christie both vetoed such insurance mandates in the past year, citing the high costs and lack of evidence that the drugs help.
Federal health officials also have pushed back against requirements to cover the drugs, citing the “staggering” costs. For example, a 30-day supply of Pfizer’s abuse-deterrent Embeda, a combination drug containing morphine, costs $268, while a 30-day supply of a generic morphine costs roughly $38, according to data compiled by Truven Health Analytics, a company that tracks drug prices set by manufacturers.
Employee stock purchase plans.
Hmmmm, makes sense but how do we explain companies that have hundred of thousands of shareholders of record?
No effect on ELTP whatsoever.
Not good news for ELPT. Any thoughts NSDAQ2020 or Weezhul?
November 25, 2016
Intellipharmaceutics Submits New Drug Application for Rexista® (oxycodone hydrochloride extended release), an Abuse Deterrent Opioid Analgesic for the Treatment of Moderate to Severe Pain
If only there was a resource to check...
Exclusivity is only granted to A new chemical entity that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Act. Oxycodone isnt new chemical entity.
Patent and Exclusivity for: N207621
NALTREXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE (TROXYCA ER) CAPSULE, EXTENDED RELEASE 1.2MG;10MG
Exclusivity Data
Product No
001
Exclusivity Code
NC
Exclusivity Expiration
Aug 19, 2019
1. Elite sues Mikah. (Insert legalese gobbledygook here: …in consideration therefore… bleh bleh bleh… breach of nonsuckitude… bleh bleh bleh… whatever… it doesn’t matter what it says.)
2. Mikah immediately settles by agreeing to refund 100,000,000 shares to Elite.
3. Nobody admits to anything other than everything is awesome.
4. Share price significantly increases upon settlement. Share price increases again when Nasrat announces in PR that he will use the shares to fund within 1 year the final applications for both ELI-201 and ELI-216, as well as to fix SequestOx. The very acheivable goal will be to have a complete platform (I.R., 12HR, and 24HR) of ADF-labeled oxycodone by end of 2018.
5. In 2018, the share price increases by multiples with each approval. BOOM SequestOx. BOOM ELI-201. BOOM ELI-216. LOL they could have 1 AdComm meeting for all three drugs.
Elite sues Mikah: could be over in a week.
1. Elite sues Mikah. (Insert legalese gobbledygook here: …in consideration therefore… bleh bleh bleh… breach of nonsuckitude… bleh bleh bleh… whatever… it doesn’t matter what it says.)
2. Mikah immediately settles by agreeing to refund 100,000,000 shares to Elite.
3. Nobody admits to anything other than everything is awesome.
4. Share price significantly increases upon settlement. Share price increases again when Nasrat announces in PR that he will use the shares to fund within 1 year the final applications for both ELI-201 and ELI-216, as well as to fix SequestOx. The very acheivable goal will be to have a complete platform (I.R., 12HR, and 24HR) of ADF-labeled oxycodone by end of 2018.
5. In 2018, the share price increases by multiples with each approval. BOOM SequestOx. BOOM ELI-201. BOOM ELI-216. LOL they could have 1 AdComm meeting for all three drugs.
Or, Nasrat could just keep those shares sitting in the Mikah account doing absolutely nothing. This is very much in his own interests.
Nasrat this is for you:
Incorrect. Thankfully.
All of the ANDAS from Mikah are FDA approved.
Just need site transfers and launch approval.
Elite’s Acquisition of 13 Abbreviated New Drug Applications
On August 1, 2013, Elite executed an asset purchase agreement (the “Mikah ANDA Purchase”) with Mikah and acquired from Mikah a total of 13
ANDAs, consisting of 12 ANDAs approved by the FDA and one ANDA under active review with the FDA, and all amendments thereto (the
“Mikah 13 ANDA Acquisition”) for aggregate consideration of $10,000,000, payable pursuant to a secured convertible note due in August 2016.
What a steal! (And I mean that.)
$ELTP purchased 12 ANDAs from Mikah for a mere $10 mil which is $840K per ANDA.
Elite’s Purchase of a Generic Hydromorphone HCl Product
On May 18, 2010, Elite executed an asset purchase agreement with Mikah Pharma LLC (“Mikah”) (the “Hydromorphone Agreement”). Pursuant
to the Hydromorphone Agreement, the Company acquired from Mikah an ANDA for Hydromorphone Hydrochloride Tablets USP, 8 mg
(“Hydromorphone 8mg”) for aggregate consideration of $225,000, comprised of an initial payment of $150,000, which was made on May 18,
2010. A second payment of $75,000 was due to be paid to Mikah on June 15, 2010, with the Company having the option to make this payment
in cash or by issuing to Mikah 937,500 shares of the Company’s Common Stock. The Company elected and did issue 937,500 shares of
Common Stock during the quarter ended December 31, 2010, in full payment of the $75,000 due to Mikah pursuant to the asset purchase
agreement dated May 18, 2010. Please refer to the Current Report on Form 10Q filed with the Securities and Exchange Commission (“SEC”) on
November 15, 2010 for further details on the Hydromorphone Agreement, with such filing being herein incorporated by reference.
5
On May 31, 2011, the Company received a letter from the FDA responding to a Changes Being Effected in 30 Days (“CBE 30”) supplement filed
by the Company with the agency to change the manufacturing and packaging location of the Hydromorphone Hydrochloride Tablets USP, 8 mg
ANDA purchased from Mikah Pharma. The letter from the FDA informed the Company that the agency has reclassified the application as a prior
approval supplemental application which has delayed the commercialization. On January 23, 2012, the Company received a letter from the FDA
approving the application.
As a result of the delay in commercialization resulting from the reclassification of the Company’s application, the Company recorded an
impairment of the ANDA asset acquired from Mikah Pharma pursuant to the Hydromorphone Agreement in an amount equal to the entire
purchase price of the acquisition.
Please refer to the Current Reports on Form 8-K filed with the SEC on May 24, 2010, June 6, 2011 and January 27, 2012 for further details on
Hydromorphone 8mg, with each of such filings being herein incorporated by reference.
Elite’s Purchase of a Generic Naltrexone Product
On August 27, 2010, Elite executed an asset purchase with Mikah (the “Naltrexone Agreement”). Pursuant to the Naltrexone Agreement, Elite
acquired from Mikah the ANDA number 75-274 (Naltrexone Hydrochloride Tablets USP, 50 mg), and all amendments thereto, that have to date
been filed with the FDA seeking authorization and approval to manufacture, package, ship and sell the products described in this ANDA within
the United States and its territories (including Puerto Rico) for aggregate consideration of $200,000. In lieu of cash, Mikah agreed to accept from
Elite product development services to be performed by Elite.
On December 14, 2011, the Company received an email from the FDA responding to a Changes Being Effected in 30 Days (“CBE 30”)
supplement filed by the Company with the agency to change the manufacturing and packaging location of the Naltrexone Hydrochloride Tablets
USP, 50 mg ANDA purchased from Mikah Pharma. The e-mail from the FDA informed the Company that the agency has reclassified the
application as a prior approval supplemental application which will delay the commercialization. The Company has been notified by the FDA
that its filing is under review.
As a result of the delay in commercialization resulting from the reclassification of the Company’s application, the Company recorded an
impairment of the ANDA asset acquired from Mikah Pharma pursuant to the Naltrexone Agreement in an amount equal to the entire purchase
price of the acquisition.
What Elite paid for was not drugs, but Nasrat's expertise.
My point was that the generics were not worth anywhere close to $10 million at any time, and certainly not worth a full 1/3 of the company. Let's say he can find a buyer for $1 billion ($1/share), then he will receive $140 million for these lame generics. At $2/share he will receive $280 million for these generics. This is money that would otherwise go to shareholders at the buyout. I hope he gets $2, but it's pretty hard to justify this kind of exorbitant payout at the expense of the shareholders. He did not have to require $10 million payment for $3 million in ANDA's, and he did not have to convert the debt to shares at the time he did. One way he could make this right is for Mikah to give back 100 million shares to the ELTP treasury.
As for your concerns about enrichment, I would suggest a small sale during the run up to 97 cents would have secured a nice pay day for him. Yet, that did not happen. Frankly, if his focus was on enrichment, he has done a bad job of it. The shares he holds for the 13 generics are not fully valued. It would be folly to suggest he would be fine with 14 cents for them. That might satisfy the test of small time investors, but not of big time senior executives who leave a big pharma firm to take the reins of a small, failing entity that they see as being the opportunity to create a legacy. Perhaps I get it because I saw it up close and personally in the Fortune 40 I worked for. It was never about the money, that would come. It was always about the power of making something big happen. I cannot more fully explain it if one does not possess that contextual understanding.
Much discussion has alleged NH has worked to enrich himself; even suggesting he has sold shares; though this argument always fails to produce evidence of the requisite SEC form. What is notable is that its absence of the SEC form would infer a violation of the law. So, the mere suggestion is ridiculous. Still, the nonsense continues that NH is enriching himself. Well, if true, why is he not taking advantage of an easy way to enrich himself while making it appear it benefits all shareholders. What am I talking about? The very thing mentioned in item #2…Share buybacks! A few words about that…
Buybacks are used when a firm believes their shares are undervalued AND, having made all efforts to improve their operations/revenues, they feel there is NO BETTER WAY to increase their value.
Knowing Avridi was voted down 23-1 due to its Tmax delay, nasrat subsequently went ahead and filed Sequest anyway... then was shocked to receive a CRL? laughable!
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.
And a monkey might fly out of my butt.
Elite's SEQUESTOX approval could be as close as March 2017 if Elite does not have major hurdles or may be as are far out as September 2017 depending on time for fed BE study.
I believe it will be the sooner timeframe.
Sounds like a reformulation.
They have given us a date to meet us in the third week of December. We believe that our proposal will address the FDA Tmax concern, and if they agree with our proposal and we will know that next month, Elite will complete additional work and a fed BE study and target resubmission in 2017. We will know more after we meet with the FDA.
As I have updated you before, Pfizer received approval for their oxy with naltrexone ER using the same technology or similar technology as we do with pharmacological approach. But they have not launched yet. We cannot compare our product and create a formulation [Indiscernible] without them launching. Then we will have access to this product. So as soon as the product is available, we will do what needs to be done to file an ANDA.
Is that a secret agreement in your pocket?
As previously stated, something big has to happen soon with Elite.
They are broke and the pipeline is stalled because of lack of funds.
LOL and exactly correct.
Last time I checked "summitted" wasn't a real word. Then again, neither is "sammich", but it is still fun to say. Goes to show level of detail & time put into their efforts.
Hey Buddy. Thanks.
Sh*ts about to hit the fan next week.
Could be good or bad.
BUCKLE UP.
The low volume is weird. Usually when there is no buying or selling pressure, the SP gets incrementally ground down with by wash trading, and that is not happening right now. It is not surprising to me that the sides are drawn pending further updates on SequestOx, but the MM's do not seem to be playing the usual games right now, whatever that means. The Preferred Shares conversion is intriguing, since there is no obvious reason to do it (other than the unknown reason why he did it). But CT order is not much more interesting than business as usual. I count 10 CT orders since 2010, so far none have been harbingers of blockbuster news. Those are usually used to hide from public reports the specific details of arrangements with suppliers and distributors, for competitive reasons.
Should be an interesting conference call, that is for sure.
First, there is no Narcan (naloxone).
"Naltrexone" not naloxone. Important difference. Second, it is incorrect to say all opioids have the "exact same" fatty meal problem, since you do not know the extent of the SequestOx tmax delay. Third, ADF's increase the abuse of illicit (street) opioids, not decrease abuse. Next, not exactly "cutting edge" since the company has been around 20+ years and antagonist ADF's are 3/7 approved ADF's, more like "well-accepted for their effective, multi-faceted abuse-deterrence of prescription opioids." Also, "politics" are your best friend, since abuse-deterrence legislation requiring ADF's will be the only way that any insurance company would willingly cover a drug that costs 5-20X the non-ADF version. (Better keep that part out of the letter to legislators, since they have to deal with all those pesky public employees, Medicaid and Medicare prescription costs. Politics, indeed.) Oh God I'm bored already, somebody else take over from here....
Weezuhl could you comment on it being "crap tech" and its acceptability in the market place. Your insight is always helpful. Thanks
The Agreement provided for an upfront cash payment of $3.5 million to Acura at execution and grants KemPharm development and commercialization rights for up to three IR product candidates containing two of KemPharm’s opioid prodrugs. Additional payments are provided in the Agreement should KemPharm exercise its option to use Acura’s Aversion® Technology with more than the three products. Acura is eligible to receive a royalty at a low single-digit rate based on commercial sales by KemPharm of all products developed under the Agreement. KemPharm will solely own the intellectual property resulting from any new product development.
You know this is the same tech that Pfizer agreed to a license for and then terminated...
Elite Pharmaceuticals Announces Exclusive Option to License its Technology Granted to Purdue Pharma has Lapsed
Northvale, New Jersey, Wednesday, August 04, 2004:
Holy Crapamoly: KemPharm licenses Acura's Aversion ADF
A total capitulation on ADF, but a potential lifeline for the company. KemPharm's pro-drug "ligand" ADF will require an outside ADF in order to qualify for ADF label. Although the pro-drug ADF was not robust enough on its own, it does have some element of overdose protection. If they can tweak the OD protection (does not kick in until pill #8), along with Acura's physical barrier ADF, could make for some tough competition in the IR opioid space.
http://finance.yahoo.com/news/kempharm-announces-licensing-agreement-acura-103000201.html
KemPharm Announces Licensing Agreement with Acura Pharmaceuticals for Aversion® Abuse-Deterrent Technology
Tue October 18, 2016 6:30 AM|GlobeNewswire | About: ACUR, KMPH
Agreement focused on KemPharm’s current and in-development IR Opioid Pipeline
CORALVILLE, Iowa and PALATINE, Ill., Oct. 18, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, and Acura Pharmaceuticals, Inc. (ACUR) today announced that they have entered into a License Agreement (the "Agreement") whereby Acura will provide its proprietary Aversion® Technology to KemPharm (KMPH) to use with its current and in-development immediate release (IR) opioid product candidates. Aversion® Technology is a patented composition of commonly used active and inactive pharmaceutical ingredients providing abuse deterrent features (ADF) and benefits for orally administered pharmaceutical drug products.
Seriously, what?????????????
It will not matter because taking both IR and ER opioids on an empty stomach makes any and all food issues a non-event.