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Get SequestOx approved asap in China and this is solved!
"comes down to SequestOx moving forward", which could be via partnership with Chinese Puracap leading to SequestOx approval in China.
Regardless of whatever delays FDA creates, it is likely that Sequest-Ox will be approved in China first and get humongous sales through partner Puracap, which controls 68% of the Chinese opioids market. And will be the first IR ADF opioid pain med on the market.
Will SequestOx get approved first in the USA or first in China? Probably first in China and soon thereafter in USA. So many different ways for ELTP to make money for us Longs!
MUST READ. rocioyogi's Post 222539 8/19/16
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.
Yes, 2002 FDA guidance AS WELL AS 2014 specific statement to ELTP THAT IT WAS ONLY A LABELING ISSUE!!!!!!!!!!!!!
i.e. pull the rug out from under ELTP at the last minute, after granting 2.5 mil filing waiver AND priority review!
Under "leadership" of new FDA director Robert Calif, well known to Congress as having been a lobbyist for BP. Coincidence? I think not.
Same T-Max issue as all other IR opioids! Being ADF or not is irrelevant to T-max issue. Hopefully, the FDA will come to their senses and re-instate what they told Elite back in 2014:, i.e. that it is a simple labeling issue. Just put in the same instructions that all the other IR opioids have. (need i repeat those instructions????—just check Lasers’s posts).
Yes, almost certainly a deliberate attempt by someone(s) in FDA to stall and/or kill SequestOX. Conflict of interest by Robert Califf, well known to Congress as a lobbyist for BP before his appointment as head of FDA.
A bummer, a huge disappointment and a setback for sure—but just a temporary setback. Our man Eugene Pfeiffer knows the ropes, has a lifetime of successes in this field and will get SequestOX approved in the near future.
WHY APPLESAUCE: because it contains specific acid that cuts through fat, according to a much earlier post on this board. BUT FACT IS all the other IR opioids have simple label and pamphlet instructions: "take on an empty stomach 1 hour before or 2 hours after a meal. Do not take more than 2 pills within a four hour period”.
If all those other IR opioid meds can be approved that way (no applesauce test required), then SequestOx should be able to also. THERE IS NO MEDICAL REASON TO REQUIRE ANY ADDITIONAL SAFETY REQUIREMENTS FROM SEQUESTOX THAN FROM THE OTHER IR OPIOID MEDS!!!
The only difference between all the other opioids and SequestOx is that you can’t get high from SequestOx (unless you take too many pills--which is true of ALL abuse-resistent meds. That’s why NO DRUG is abusePROOF. No drug can stop you from being a jerk either).
Nasrat: “their concern is that this is instant release and it’s used as needed so if you take it when you need it and you just ate a lot of fat then it affects you”.
This exact same situation applies to any and all IR opioids, so the FDA should be consistent in their requirements for dealing with this T-max issue: either approve all IR opioid meds (whether ADF or non-ADF) with simple labeling instructions or withdraw approval from all of them.
It is well known that the majority of meds are affected in some way (eg faster or slower rate of absorption; greater or lesser amount of absorption) by interactions with various types of foods (eg fat, dairy, alcohol, grapefruit, as well as with other drugs the person may be taking).
There is no 100% perfect, universally applicable drug, that applies to 100% of situations instantly (i.e. regardless of other factors present in the patient’s body). That’s why easily understandable written directions are needed on the label and/or an insert: Take 1 hour before a meal or 2 hours after a meal. Do not take more than 2 pills within a 4-hour period”.
Similarly, there is no 100% absolutely abuse prevention drug in existence for the simple reason that someone can ingest a whole bottle of pills at one time. That’s why all types of ADF formulations are called “deterrents” (rather than “abuse proof”). BUT SOME ADF FORMULATIONS HAVE MORE EFFECTIVE DETERRENT PROPERTIES THAN OTHERS. SequestOx is one of the MOST EFFECTIVE. If FDA wants to save lives from abuse of opioids (intentional abuse or the more usual un-intentional abuse), they should approve SequestOx asap!
No doubt, Nasrat and our guy Eugene will solve this issue with the FDA and get it approved soon.
The $100,000-Per-Year Pill: How US Health Agencies Choose Pharma Over Patients
Friday, 05 August 2016
http://www.truth-out.org/news/item/37111-the-100-000-per-year-pill-how-us-health-agencies-choose-pharma-over-patients
Does anyone see a chance of returning to the highs of a few years ago (around 9 cents .09)?
FACT: ALL IR opioids have THE SAME T-Max “issue”—i.e. fatty meal slows down absorption. So the same safety labeling used by other FDA approved opioids (including Opana IR Oxymorphone) should similarly be sufficient for SequestOx! NAMELY “TAKE ONE HOUR BEFORE A MEAL OR TWO HOURS AFTER A MEAL. TAKE NO MORE THAN 2 PILLS EVERY FOUR HOURS”.
THERE IS NO MEDICAL REASON to make the rules for dealing with the SequestOx T-max situation any different than for any other IR Opioid pain med!!! There is no more chance of over-dose on SequestOx than for any other IR Opioid pain med!! FDA KNOWS THIS! THAT IS WHY FDA IN 2014 TOLD NASRAT THAT LABELING INSTRUCTIONS WERE ALL THAT WAS NEEDED TO DEAL WITH THIS T-MAX ISSUE!
The FDA did a switcheroo at the last minute (after having granted ELTP a $2.5 million fee waiver and after having granted ELTP priority review). THERE WAS NO MEDICAL REASON for this switcheroo! THERE IS NO MEDICAL REASON why full approval was not granted on July 14th!!! It was obviously a politically (and/or financially) motivated decision in order to stall the entrance of SequestOx into the marketplace (or for some other politically motivated reason. FDA director Robert Califf was well known to Congress as a BP lobbyist before his appointment so it seems likely that conflict of interest was involved But additional political reasons also possible).(See No2Kool-Aids posts on this).
However, other political pressures exist to strongly motivate Califf to approve SequestOx because Congress wants ADF opioids to be available to replace non-ADF opioids that are causing so much abuse, death and enormous cost to the American people. Therefore, it is in Califf’s best interests to soon grant approval for SequestOx, which he will do. Our guy Eugene will get this problem resolved just like he’s previously gotten many other difficult problems resolved.
FACT: the T-max "safety issue” for SequestOx is exactly the same for all IR opioids, whether ADF or non-ADF. (And similarly to many other kinds of drugs. Shall the FDA recall all those previously approved drugs)???
That is why all FDA approved NDA and ANDA IR and ER Oxymorphones come with the same instructions : "should be taken on an empty stomach, at least one hour prior to or two hours after eating. TAKE no more than 2 pills every 4 hours”.
Simple labeling fix and this fix was told to ELTP by FDA in 2014.
"The FDA had all of this information about SequestOx and they still sent Elite" a $2.5 waiver of application fee and a priority review!!!
"Safety issue" (T-max) for SequestOx is exactly the same as for all other IR opioids! Simple labeling instructions take care of that issue just like on all other IR opioids "Take 1 hour before a meal or 2 hours after a meal". Can add "Do not exceed 2 caps within 4 hours" (or whatever the correct amount is, i am not certain).
In addition, while waiting for the FDA to approve SequestOx (which it will), there is CHINA! It could be approved in China regardless of status in USA. HUGE market.
Our guy Eugene has won his case many many times before and he will do so this time as well! ELTP WILL PREVAIL!
QUOTE "There's something else going on! Why is it for so many folks here to realize that”?
REPLY: Many of us do realize that something else is going on besides a simple labeling issue. That something else is a blatant attempt on the part of Robert Califf to stall/subvert/undermine the approval of SequestOx to benefit his BP buddies. Before his appointment as head of FDA, it was well-known (and a serious concern to many in Congress) that he was a lobbyist for BP.
Fortunately, Nasrat was prepared for the possibility of having some big legal fights coming down the pike related to SequestOx. That is why he hired Eugene, who has loads of experience and success in handling these battles. ELTP will prevail! SequestOx will be approved and will make a big splash in the market! You will see.
AQUA AND LASERS--There is no problem or error whatsoever with SequestOx! The only problem is $$$$$$$ BP/FDA collusion to stall entry of SequestOx into the marketplace! SequestOx would (and ultimately will) contribute significantly to solving the huge problem of opioid addiction in new users (i.e. non-addicted ones) of pain meds who need them for pain reduction (not for getting high).
The same label that is used on all other IR opioid meds ("Take one hour before a meal or two hours after a meal") should be entirely sufficient for SequestOx. There is no logical reason to require anything more. Abuse deterrent SequestOx takes care of pain in exactly the same way as the other opioid meds. The only difference is that you can’t get high from crushing, snorting or injecting it. Therefore, there's far less chance of over-dosing!
As to the notion that the CRL was due to a big change in the climate of the FDA since 2014, the 2.5 million fee waiver for Elite’s application and the priority review were both granted just a few months ago, quite a long time after 2014. Fact is, the rug was pulled out under ELTP at the eleventh hour.
The “big change” in FDA is in the person of director Robert Califf, whose potential appointment was a matter of serious concern to many in Congress specifically because he was known to be a lobbyist for BP. Now we see that this concern was well justified since, as head of the FDA, his first priority appears to be doing what is best for BP instead of what is best for the health of the American people.
100% agree FDA $$$$$$intentionally stalled/screwed Elite, but it's just temporary setback. Meanwhile, Epic/Puracap should be working to get Sequestox approved in China. Any way we can know if this is on their agenda and/or influence them to get this happening?
I will start by calling Diane. The more calls from other investors about this, the better, imo.
LASERS, this is crucial info, imo. What is your take on this?
Certainly seems to wipe out possibility of fixing the problem simply by a label change.
I think the reasoning for FDA decision on Avriditi is absurd: "Panelists' main concern was that the drug's requirement to be taken on an empty stomach would be too complicated for patients to manage"--but there it is. And no reason to think FDA would give a better decision for SequestOx on same issue.
This is BS! A great many drugs are affected by food--especially by big fatty meals--and grapefruit--all opioids are, so far as i know, affected by fatty meals.
As several others have posted, just put good directions on the label, such as: "do not take with fatty food! Take one hour before eating or two hours after eating".
If grapefruit is a problem (it increases the effect in many cases) address this too in the label. Simple.
China approval??? During this time of doing whatever might be involved in getting approval in USA, what about Epic/Puracap getting Sequestox approved in China???
Lasers--Instructions would have to emphasize NOT TO CHEW (because then the naltrexone would be released instead of the Oxy)...
But not everyone has applesauce in their pantry...it's kind of like applesauce becomes part of the prescription...part of what you have to have along with having the drug...
???
This CRL does not in any way change the fact that ELTP passed every clinical trial with flying colors and that Nasrat has accomplished a huge amount in record time. Filing the NDA a bit later than expected, in order to get a fee waiver, saved the company a very large sum of money. This is the time to stand with our CEO, not to bash him. Ultimately, we will succeed, hopefully in short order or fairly soon. Be decent, people!
Serious question: how, exactly, is legal MJ gonna help EFFI significantly? it might seem obvious to you but it doesn't to me. I would love for this to be true, btw...
Is this thing ever gonna reach .06 like a few years ago??>
"Gonna explode", as in above .05 like 2.5 years ago???
Does anyone expect we ever reach at least $0.06 again?
What are you saying is very possible from here? Earlier you said "high teens". With how many zeros in front? Are you suggesting .0010 or .10 and beyond???
you mean like .00019?
Article on GLARING CONFLICTS OF INTEREST IN FDA for Zohydro and much more: Former FDA commissioner Hamburg was primarily responsible for Zohydro approval, along with her husband, whose income soared from $10 million to an estimated $125 million within 3 years. Also mentioned is new FDA chief Robert Califf.
http://articles.mercola.com/sites/articles/archive/2016/06/01/industry-money-unsafe-products.aspx?utm_source=dnl&utm_medium=email&utm_content=art1&utm_campaign=20160601Z1&et_cid=DM107057&et_rid=1509447239
LASERS: Was 3mg naltrexone the amount used in the “liking” clinical trial? and all the other trials? I don’t recall it being stated what the amount was in any of the trials but i would think the same formulation would have been used throughout the trials. Is this correct? Where did the “50 mg” number come from?
TIA, my one post for the day.
Still waiting to hear even one plausible reason for FDA to refuse approval of Eli-200 (SequestOx).
(My one post for the day)
Can anyone name a single plausible reason for FDA to deny approval of SequestOx? If so, please state it.
Won't ELTP have to wait for Pfizer's patent to expire before a generic is allowed?
My point is that there is no cascade of panic selling. Shareholders are not being scared into selling. Instead, they are buying, accumulating, even many who already have large holdings.
Nonsense. DD Longs know the pps is in this narrow channel till approval, and don’t expect anything else. Approval is on FDA time but Priority Review and specified Target Date puts it most likely at July 14, 2016.
To criticize the company or the CEO for the stock pps not moving upwards right now is ridiculous at best.
Whatever is sold by MMs is quickly bought, in many cases by Longs who know what a bargain they are getting.
Does anyone here think we'll ever see .05 again??? Does it depend on legalization in California? Federal? or what? TIA
"will crush all expectations for everybody"??? Like go back above $0.05 within a year?
How can you tell that a particular individual is buying (unless it's an insider who has to declare)?
Couch, please explain clearly what you mean here. Is this manipulated non-fill gonna hold us back indefinitely?