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Very insightful indeed. Looks like the data and EVIDENCE or PROOF, as some call it, is in our favor for Sequestox.
I also like that you provided a link to your post. It allows people to verify what you are saying instead of leading one to believe it was NONSENSE.
Well I've reached 15 for the day. Wonder what fun and exciting things tomorrow may bring. 10 cents? 6 cents? Or .038?
Oh that's right it doesn't matter because elite pharmaceuticals will get approval and as you say......NEXT.....as in Eli 201....Eli 216....take your pick!!
PERIOD
Questions are.....
Does the FDA require a new BE study with fatty meal and sprinkling?
If so how quickly can elite accomplish this BE and include a packaged "response" presentation or data to the FDA.
Does this fall into class 1 because of the additional data that would supplement original data.
Hence why I have stated even with another BE this could be done with an approval by years end.
Well I can tell you this. We get an adcom we will know 100% the truth of Tmax and all the people who "demand" material information will get what they want to know. Also we will know if Nasrat has been "willfully deceiving" investors.
So people who claim Nasrat is a liar or spinner of truth and this crap about zombie sequestox will be brought to light.
Maybe we can get Adam Feuerstein, I think is his name who does adcoms for drugs seeking approval. I forget who he works for but he does a very unbiased play by play of the adcom.
It doesn't matter what the PPS does after the CRL. It could keep going until the CC in August. But there will be an update from the FDA and Elite meeting. Then there will be a path way forward to.....APPROVAL.
We will also be getting a quarterly update that will show yet again another huge leap in revenues.
Then we have the one per quarter filings to the FDA for a pipeline that BP will be drooling over.
.147 .10 .068 .038
IT DOESN'T MATTER. PERIOD
Yeah the guy who im.sure could have been enjoying a nice retirement with loads of money from his previous experience to only come and help out this "flailing company".
Yeah the guy who has single handedly both helped the FDA and also brought the FDA to their knees with certain drugs.
Yeah that guy!
Zoloft is a good drug. Have you seen the instructions for that?
Does it say to take with wine?
Or cheese to go with the wine?
I agree couch. Nothing has changed. There is ZERO reason this stock should be acting this way. But obviously some different ideas.
But what also shouldn't be happening is people freaking out and calling the CEO and the company into question. Or calling the flagship drug, to send this off the OTCBB, zombie sequestox.
PPS means nothing in the long run.
SEND IT DOWN TO .0001 BUT IN THE END THIS WILL BE BIG $$$$$
NOT SELLING UNTIL NASRAT SELLS HIS SHARES TO BP
So just like that you now believe this is BS?
After calling it zombie sequestox?
Actually stating they probably knew 3-4 days before the 14th is reckless.
If you knew you could see by the SEC filing that they knew ON July 14th at SOMETHING point THAT day. Even though the filing came out on the 15th after hours at the very top of the filing it states "earliest report" date or something along the lines of earliest reporting which is the 14th of July.
They did not know 3-4 days in advance of the 14th.
And isn't there a 3 days window to report from date of material information known?
My 2 cents and strictly my opinion is today's sell volume was from the 20M shares on last Monday when we dropped to .152 cents and then rebounded.
The buys that took place Monday and now are minimizing risk or not wanting to wait around and have a lower price then when they bought.
But that's strictly my opinion.
You don't lose what you don't sell.
Like I stated.......nonsense
Fully understand. I am not selling by a long shot. But being on here trying to provide useful information and links to correlate with relevancy with sequestox
We are at a point NOW where there is nothing new to say. It's been put out on the table and now we are just repeating everything we say to nauseating results.
UNTIL NH COMES OUT AND SAYS SOMETHING VIA SEQUESTOX AND THE ROUTE FORWARD AND HAVE ACTUAL PR STATING NDA'S OR ANDA'S ARE BEING FILED THERE IS NOTHING MORE TO SAY.
I'm not going to keep posting the same thing over and over. I belive in sequestox and elite pharmaceuticals but right now nothing is new and nothing has changed.
Just a waiting game right now. But I prefer to wait outside of this MB.
NONSENSE
PERIOD
That's where I think a lot of believers of ELTP are right now. Nothing that we can say on here or do is going to help the company. Knowing the data would be nice for our own sanity however ALSO not going to help the company.
Going back and forth with people on share price is a little over the top. I think it is a good time to step away from the board. Until actual news hits the waves and our ceo has a plan to move forward. Watching this board is like watching the circus.
Everything at this point has been said to point at the way forward for sequestox and elite pharmaceuticals.
THIS is a glimpse at what OLE GENE Pfeifer can do for ELITE
Take a look at these links showing what a little proof and evidence to support claims can do.for drug companies.
Oh I don't know. Maybe he can do the same for Elite Pharmaceuticals.
http://www.google.com/url?sa=t&source=web&cd=4&ved=0ahUKEwj7o9bi4Y_OAhUH6x4KHS28BlQQFggjMAM&url=http%3A%2F%2Fwww.accessdata.fda.gov%2Fdrugsatfda_docs%2Fappletter%2F2001%2F75817.ta.pdf&usg=AFQjCNHO-YygXPCeDcwjtqJ7z6wvmTv5eA
http://www.google.com/url?sa=t&source=web&cd=6&ved=0ahUKEwj7o9bi4Y_OAhUH6x4KHS28BlQQFggoMAU&url=http%3A%2F%2Fwww.accessdata.fda.gov%2Fdrugsatfda_docs%2Fappletter%2F2001%2F75950.ap.pdf&usg=AFQjCNFhaIWq-U7jt6c8kBBxrbwyF480dw
http://www.google.com/url?sa=t&source=web&cd=7&ved=0ahUKEwj7o9bi4Y_OAhUH6x4KHS28BlQQFggrMAY&url=http%3A%2F%2Fwww.accessdata.fda.gov%2Fdrugsatfda_docs%2Fappletter%2F2002%2F75945ltr.pdf&usg=AFQjCNEM0Q-1wTQo6d5qJgt63yCBIpgOsw
3 examples of how one man can and some proof and evidence can over turn an fda decision
Wow pretty hard to dispute the FACTS AND EVIDENCE that precedence has been made and sequestox could very well get approved based on this finding.
Eugene Pfeiffer I'm sure is laughing and saying. I got this.
PERIOD
Yeah I was aware. Thanks?
The different types of classification for resubmission.
2 months and 6 months
I personally think 2 months for even the BE study.
The BE study is a simple week long at most study in which they document blood samples at different intervals starting with I believe 30 mins after med administration to around the 10 hour markers. At first 30 minutes intervals then hour intervals to get the tmax and cmax concentrations.
I mean really how long does should that take to review and analyze. Then put together a PowerPoint and document findings.
That's why I say it can be done over a long weekend and or a week's time to package(if truly wanting to)
Then resubmit. 2 months review period.
This is all my opinion. Sure we can "what if" all day long. But I think even with a BE study this can be done and approved by years end.
THESE FORWARD LOOKING STATEMENTS ARE JUST THAT. THEY ARE MY OPINIONS ONLY.
I am not completely sold that Elite can not have this approved by labeling change. I think given the overwhelming proof and evidence that a case can be made upon past practice and overall ADF purposing needed to deter ABUSE not misuse Sequestox can still be approved with good labeling.
On the other hand I can see the fda saying a new BE study will be needed. If that's the case the study should not take long. Roughly 25-50 people should be all is needed. Do a fatty meal apple sauce or even redo Tmax taken to show Tmax curve. All this can be done in a week from start of trial to end of trial. Now how long it takes to get to the start is a question NH can answer. But then compiling the data should and could be done over a long weekend or even a week. Resubmit and allow the fda 2 months to review.
Either of those can be done within the years end.
Your thoughts?
Wow MAZ. I think that pretty much sums it up for Sequestox and elite pharmaceuticals.
Period
That's what we have been trying to say all along. But we also backed it up with facts and links.
I agree we don't know the tmax.
But avridi was 4 hours to 9 hours range and that was unacceptable in late 2015. But in march/April 2016 those new guidelines changed. So I'm saying goes IF our Tmax was 4 hours in a fed or fatty meal that would have been acceptable as of 2015.
We all know the guidelines changed mid review for sequestox.
So sequestox is now just like regular oxy?
No ADF whatsoever?
Now the TMAX delay is beyond that of regular oxy?
What is the normal range of Tmax in the fed state for "regular oxy"?
Because if you knew the FDA'S stance on fed Tmax in "regular oxy" you would know the acceptable range is indeed 4 hours based upon past precedence for opana and also the avridi adcom.
Then if that's the case then EVERY IR opioid needs to be pulled all together and show better TMAX results in a fatty meal or fed state.
Precedence has been set. Now Eugene Pfeiffer, the litigator, has a case to make for fda to get off their arse and approve sequestox.
But we all know FDA do what they want
Why would Nasrat Hakim NOT sell the company when he had the chance to?
If he has approximately 175M shares, as of last SEC filing don't worry I checked, even he got some "low ball" offers he could have walked away with millions of dollars and not have to do a thing to get that money.
Who would walk away from free money with zero head ache or stress?
A person who knows obviously the true value of a company at the precipice of being worth so much more. That's who!
PERIOD
Hey MRW.....I found that "PESKY" pediatric study that I was talking about in the 10k/a that was 3 days before pdufa date.
Exhibit 10.85
Here is the quote:
Thanks MRW....
My apologies for mistaking the pediatric studies was referenced in the CT but in actuality the pediatric studies was referenced in the 10k/a.
But I guess the bottom line was Elite’s PowerPoint in April of 2016 stated post approval a pediatric study was to be done. And of course 3 days prior to PDUFA date the 10k/a stated about a pediatric study.
So my entire point was even 3 days prior to the PDUFA date they were still ready to move forward with the pediatric study.
Hence making it even more proof that Elite was blindsided by the CRL.
"Facts" PERIOD
It's ok greenlife....
Elite is on the rise. The FDA "crl" was a shock to all who believe in Elite pharmaceuticals.
Too many good things in the works for Elite pharmaceuticals to be some OTC "zombie" "nonsense"
Oh.....and PERIOD
Wow. I guess I was right then when earlier I said that IR OXY had delay in TMAX due to fatty meals.
I guess that means that Sequestox would be normal to show delay in TMAX due to fatty meal.
I guess Elite HAS a pretty good evidence that sequestox should have been approved and good Ole Eugene Pfeiffer is going to get us approval after all.
"evidence" out weighs "nonsense"
PERIOD
Buy sell or hold; Elite pharmaceuticals is a profitable company with revenue that has increased every quarter and when the 10Q comes out we will see yet again an even more impressive revenue stat line.
With 6 new applications being filed with FDA and technology has been proven to work the only direction for ELTP is UP.
Let's let the company do what they need to do and people who believe in Elite reap the rewards for being patient and understanding that as Nasrat stated....
"WE DON'T ROLL OVER AND PLAY DEAD. WE SOLVE THE PROBLEM AND MOVE ON"
If Nasrat was "willfully deceiving" shareholders on "material information" why would he brief investors on a POST APPROVAL pediatric study....then 3 days prior to PDUFA date issue a Confidential Treatment order about a pediatric study if he "KNEW" sequestox wasn't going to be approved due to TMAX delay?
Hogwash to say our CEO has been engaged in willful deception and withholding material information when FDA says to proceed with Sequestox then only to pull the rug out from under their feet in the 11th hour of a priority review NDA.
Elite pharmaceuticals has been compliant and willfully WORKING either the FDA every step of the way to gain approval of Sequestox.
ELITE PHARMACEUTICALS IS IN THE BEST POSITION IT HAS EVER BEEN
Minor hiccup with the FDA but Sequestox will get approved like it should have been on July 14th 2016.
Revenues increasing every quarter since 2015
6 NDA or ANDA in the next 1.5 years; one every quarter
Technology platform for ADF opioids has been green lighted by FDA
MY IT IS A NICE TIME TO BE AN ELITE PHARMACEUTICALS SHAREHOLDER
Just in case you doubted me. This is straight from the FDA Website regarding drug process from IND to approval and beyond.
I also provided a link so it can not be disputed what Elite Pharmaceuticals did with their flagship Sequestox NDA.
Here is the excerpt and below that will be the link.
Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm
Incorrect. On January 13th the FDA stated they have "received" or "accepted"" the application. The FDA actually has 60 days to "accept" and application or to make notification they "received" it.
This is all been discussed and it is on the FDA'S website stating such.
Elite pharmaceuticals sent in the application prior to January. The FDA finally "accepted" the application and deemed it to be "filed" on January 13th.
Just like sending a package via UPS or USPS with tracking numbers. You send something and prior to it arriving it may say arrived but until the person receives it and accepts it are 2 different things.
It's all on the FDA'S website about how they process an application. Words here are easily manipulated and abused unlike sequestox from Elite pharmaceuticals.
LASERS.....what do you think about this? I find it pretty interesting about ELITE PHARMACEUTICALS
The NDA was submitted prior to 2016. The FDA received the NDA in January for review. March is when the FDA accepted the submission for priority review. 27 days later Eugene Pfeiffer joins. Which is one day shy of 4 weeks which is essentially 1 month AFTER FDA granted priority review.
Also I would like to point out something that I don't think is coincidental at all. People say Nasrat withheld material information or is willfully deceiving investors. On the PowerPoint presentation that Elite has on their website for investors there is a slide that discusses the steps taken for Elite in regards to sequestox. Listed below:
Elite’s First ART™ NDA Filing:
? Prior to NDA filing, SequestOxTM was referred to as ELI-200
? Successful formulation/technology: Complete
? Pivotal BE study: Complete
? Registration batches: 6-mos ACC, 24-mos CRT Complete
? Lab Abuse Study: Complete
? Liking study, intranasal: Complete
? Fed Study: Dosing complete
? Withdrawal Study: Dosing complete
? Efficacy Study: Dosing complete
? Pediatric study: Post product launch
? Pre-NDA meeting: Complete
? NDA filing: Complete
There are claims that Nasrat also "knew" all along that the drug was doomed and it's a zombie. Shown above is the PowerPoint presentation dated April 15th 2016(Which again was after fda accepted the SequestOx nda). It shows as listed above that a pediatric study was to take place post product launch. His PowerPoint shows in april that they were assuming an approval was imminent. If you remember I believe a few days prior or the PDUFA date of july 14th 2016 there were a few SEC filings. One of which I believe was the Confidential Treatment order and it discusses the "pediatric study" with an undisclosed partner.
If Nasrat "knew" all along it was doomed yet days prior to PDUFA date puts out a filing discussing the very pediatric study that would only come about if the drug was approved then how can you explain that.
I feel like some have jumped the gun on this "zombie sequestox" crap.
I have also pointed out over last few days the TMAX of current drugs approved with same Tmax issue. Also I have refuted the avridi comments by noting that avridi had not only Tmax delays of 4 hours to 9 hours and well beyond the FDA accepted Guideline of .5 hours to 4 hours for Tmax. Avridi even had cmax decrease of I believe 27% and auc was less than acceptable too.
I know we all are just trying to rationalize what's going on but there is actual evidence that people's comparisons of avridi or Embeda to "zombie sequestox" has no merit.
It's just a shame people dont want to look at evidence about sequestox and elite pharmaceuticals in my opinion.
What do you think?
http://www.healthandwelfare.idaho.gov/Portals/0/Medical/PrescriptionDrugs/AnalgesicsShortActingNarcoticAnalgesicsd.pdf
Slide 19 of 30 states:
Oxymorphone IR (Opana) should be given on an empty stomach; maximum concentration and area under the curve were increased 38% when given with a high fat meal.
So current IR oxy can have affects from high fat meal on CMAX and TMAX, label it as such with regards to taking on empty stomach, label it to state such delays could occur from fatty meals, and one current approved ER can state such direction to sprinkle on applesauce......yet sequestox can not!?!?!?
WTF.....FDA needs to wake the F up. The more and more I come across about current IR opioids with similar TMAX or even CMAX delays or lower concentration affects makes me believe that FDA has either set the bar way too high for ANY pharma big or small to jump over or that the FDA has an agenda.
One can not look at the "circumstantial" and "coincidental" evidence against the FDA that shows there should be no reason Sequestox got a CRL.
APPROVE SEQUESTOX NOW!!!!
COUCH, after seeing the ADCOM data presented for Avridi (Which in my opinion is not 100% comparable to Sequestox due to delivery technology and deterrent abilities...not to mention the ability to sprinkle sequestox versus avridi being a tablet; and the only thing they share is they are IR)
Also seeing the FDA response to Avridi, if Eugene and Nasrat can not satisfy the FDA with relabeling, I foresee the FDA and Elite coming up with a BE study where they allow Sequestox to be sprinkled with a fatty meal and it will show the TMAX issue within normal rage of .5 hours to 4 hours. This is the acceptable range of time for NON-ADF IR opioids.
Sequestox will be approved with out some stupid "zombie sequestox ****" as others have pointed out.
Look at the data, the precedent set for NON-ADF IR that has Tmax delay, and then precedent set for Embeda allowed to "sprinkle". FDA wants and NEEDS IR oxy with ADF ASAP.
FDA SAYS OPANA IR (NON ADF) is OKAY to to have labelling that states MUST be TAKE ON EMPTY STOMACH
Extended- and Immediate-release Opioid Analgesics
• Generally labeled to take without regard to food, e.g., no
significant food effect
• Opana ER (oxymorphone ER) and Opana (oxymorphone IR) are
labeled to take on an empty stomach due to food effect (Cmax
increased by 50% in fed state compared to fasted, slight
increase in AUC)
And my last post for free today will be what the FDA had to say about avridi and allow people to draw their own comparisons to sequestox.
The FDA was NOT very friendly to avridi.
TMAX should have a normal range in current non adf OXY of .5 hours to 4 hours in FED state; avridi took 4 hours with 27% lower CMAX as well.
[color=red]
Elite is no where close to this level. Avridi can not be sprinkled on food to diminish the TMAX unlike sequestox can.
And it was only ADF for IV and nasal where sequestox is everything but swallowing which we all know CAN NOT be done to determine abuse.
http://www.google.com/url?sa=t&source=web&cd=10&ved=0ahUKEwjio93HpIrOAhWBdR4KHSO3B9AQFghFMAk&url=http%3A%2F%2Fwww.fda.gov%2Fdownloads%2FAdvisoryCommittees%2FCommitteesMeetingMaterials%2FDrugs%2FAnestheticAndAnalgesicDrugProductsAdvisoryCommittee%2FUCM462838.pdf&usg=AFQjCNH4uqYeDFrB137L1FrEzvdvuxNYzw
This talk about avridi being comparable to sequestox can stop here.
Avridi had a TMAX that was 4-6 hours with far lower concentration levels of roxicodone. The abuse deterrent formulation they used was ONLY for IV and Nasal where sequestox is deterrent in EVERY WAY other than someone swallowing 20 pills at one time.
Here is the Avridi ADCOM presentation link below:
Not only is avridi inferior in its ADF abilities to Sequestox their PK study was horrible in contrast to Roxicodone.
http://www.google.com/url?sa=t&source=web&cd=9&ved=0ahUKEwjio93HpIrOAhWBdR4KHSO3B9AQFghCMAg&url=http%3A%2F%2Fwww.fda.gov%2Fdownloads%2FAdvisoryCommittees%2FCommitteesMeetingMaterials%2FDrugs%2FAnestheticAndAnalgesicDrugProductsAdvisoryCommittee%2FUCM462840.pdf&usg=AFQjCNHSbY8KOc6mrQdM5eGBsJqUpYTCTA
And who has said it's a faulty drug?
The FDA? Nope
Elite? Nope
People here on the MB....ding ding ding
All I can say is everyone has free will. Don't believe in elite? Then there is one way to handle it.
Don't trust the CEO? Then there is one way to solve it.
Instead we call sequestox a zombie drug. And call the CEO a rat and say how the company has misled the shareholders for 2 years without 1 iota of proof.
Only one way to handle it if you don't like elite pharmaceuticals.
Everyone seems to be missing the point here. In 2014 the FDA said it was not a problem. PERIOD
Then in 2016 of April when the new guidelines came out...(Which was 4 months after FDA accepted the application from elite) the guidance changed leaving Elite caught out in no man's land.
No one wants to acknowledge that the guidelines FDA said was acceptable in 2014 changed in 2016 which was 3 months prior to PDUFA date.
So what does everyone do.....bash the CEO the company and now calling the very drug that every LONG once hailed as the flagship drug....now call it zombie sequestox.
Horse SH*T
LOL LOL LOL....WOW I'VE HEARD IT ALL NOW.