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Lol ok.
Like always I will ask you for your thoughts or proof to support your claims of "nonsense"
And I will wait and never get an answer.
PERIOD
At least I give proof to support my claims about sequestox and Elite that is backed with links to factual evidence.
Quoting people on this MB does not signify proof or facts.
PERIOD
ELITE WILL OBTAIN APPROVAL FOR SEQUESTOX OR AS THEY SAY "ZOMBIE" SEQUESTOX
Ding ding ding!!!!!
We have a winner.
But everyone is freaking out because one long has now dubbed this "zombie sequestox"
Allow Elite to do what they need to do. They brought in these people who have DIRECT ties to knowing how the fda red tape works and have even worked for the fda.
I still think approval of Sequestox before years end.
Ok SNUP.....so from what I have read is the original LPC agreement was for $40M and as of july 11th of the $40M agreed upon only $21M and change has been used by elite.
That leaves $18M and change left for Elite to tap into for funding.
The tiered levels I referenced were "assumed" prices. But does say this.....
"The prices at which Lincoln Park may sell the shares will be determined by the prevailing market price for the shares or in negotiated transactions."
But bottom line is that Elite still has $18M to use with a 63M shares still left for LPC to purchase for the $18M.
And regarding how they will use it...here it is per the 424 Prospectus just filed by Elite....
"However, we may receive up to approximately an additional $18,093,398 under the Purchase Agreement with Lincoln Park. Any proceeds that we receive from sales to Lincoln Park under the Purchase Agreement will be used to fund the production development and commercial activities of the Company"
Hey snup. If memory serves me correct the LPC shares were aggregated over different price points based upon the current share price. These total shares had a combined total amount of $18M and change. Now whether or not their are different "tiers" like I just described I will have to look back again.
But I'm pretty sure that's the case. So we know the filing fee for NDA is roughly $2.3M dollars each filing. (That is if it's $2.3M for both NDA or ANDA)
So I would be ASSUMING that the LPC has a direct correlation to filing the 6 drugs over next 6 quarters.
Because $2.3M x 6 is.........(roughly $14-$15M)
But obviously this is me ASSUMING. We also have some nice revenues coming in and I would think this Quarter coming up will yet again be the best quarter ever for elite.
All just MY thoughts
Another interesting article DIRECTLY from the FDA Website
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm
Seems as if #6 and #8 in the referenced article that Nasrat wasn't lying about constant communication and the fact that prior to submitting the NDA for approval the FDA had NO PROBLEMS but then "changed their mind"
And #10 speaks to what some of us think is the a safety issue but a mere labeling issue.
Also I would like to mention yet again that the FDA makes the determination to approve or grant a company to proceed with every step. The company does not just arbitrarily proceed with out the FDA having a strict say in each step
6)
The pre-NDA period, just before a new drug application (NDA) is submitted. A common time for the FDA and drug sponsors to meet.
7)
Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
8)
After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
9)
If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor's research on the drug's safety and effectiveness.
10)
The FDA reviews information that goes on a drug's professional labeling (information on how to use the drug).
Looks like Nasrat wasn't lying about constant communication with FDA
http://www.raps.org/Regulatory-Focus/News/2015/03/10/21689/Meeting-With-FDA-Heres-What-Regulators-do-and-Dont-Want-from-Drug-Companies/
Also by the article referenced we have our timelines for meeting with the FDA to discuss what needs to be done. Also if you read the article it shows how a company can have a "presentation" ready for the meeting. I wonder if Eugene Pfeiffer has been earning his keep the last 9 or so days since the CRL.
Article about CRL issuance and the MISUSE of such ability to issue
http://www.mondaq.com/unitedstates/x/371622/Healthcare/FDA+Complete+Response+Letters+The+Design+v+Reality+Of+The
Several good tidbits of information. That would pertain to Elite and Sequestox but my favorite is below and in BOLD
The Context of CRL Responses Matter
The receipt of, and a company's response to, a CRL can have an impact on a company's business, including the company's ability to raise funds and manage shareholder reactions depending on how CRLs are viewed. Despite what is apparent misuse of this administrative tool by the FDA, CRLs are and should be viewed by the recipient as, an opportunity to strengthen its application and therefore the chance of approval. Responding, however, is a complicated and detailed process. Failure to respond to an issue or application discrepancy could decrease the chances for a subsequent approval. However, receiving and responding to a CRL leaves unanswered questions such as, "how does a response affect a small business waiver of filing fees?" Can preclinical data already received and accepted as part of an IND approved be the basis for deficiencies cited in the CRL? If such preclinical data has already been received and accepted by the FDA as part of a company's IND but guidance has changed, can the company be expected to redo data that was acceptable at the time and has no effect on the safety profile, be required to constantly redo the data in order to satisfactorily respond to a CRL?
I agree COUCH & LASERS
While comparing sequestox to let's say Embeda would be like comparing apples to oranges. But comparing sequestox to avridi is like comparing apples of red to apples of green. Same fruit but different uses or tastes.
The ONLY the FDA should be using as a comparator is SequestOx IR with ADF to oxycodone non ADF.
If there is a TMAX delay in oxycodone non ADF and sequestox ADF shows similar Tmax delay. The FDA needs to wake up and realize that an ADF Oxy IR is more important to curbing the epidemic than some bullshit "fatty meal" worry.
Yes hence my sarcasm in my last post with the FDA Guideline that I say
"FDA wants ADF opioids on the market to curb an epidemic but thus far done a very very good job of leaving such opioids on the market that has helped caused the epidemic. Because they are more concerned about a fatty meal and someone OVERDOSING."
Seems hypocritical to want ADF opioids because 44 people die a day via overdosing but then use an excuse of a fatty meal.
Read on the next posts about labeling.
Ummm no.
But I will say thanks but no thanks too.
I don't know what you mean because what you said did not make sense.
And my favorite part of the FDA'S own guidelines for industry says......
All of these statements based on Categories 1, 2, or 3 testing should be followed by a statement
that data from laboratory and clinical studies may not fully predict abuse potential in the post-
approval setting.
And the fda is worried about a "fatty meal". Yet willing to allow labeling say the catch all phrase of "may not fully predict abuse potential"
You've got to be kidding me. Yeah FDA is concerned about ABUSE DETERRENT Formulations being on the market alright. Seems to me if you can add a "caveat catch all legalese" phrase such as the one above then adding "affects may be delayed if eating a fatty meal" CAN NOT be added then THERE IS NO HOPE FOR ANY COMPANY MOVING FORWARD.
And finally...FDA'S stance on labeling
VI. LABELING
Including information about a product’s abuse-deterrent properties in labeling is important to
inform health care professionals, the patient community, and the public about a product’s abuse
potential. Accordingly, FDA encourages sponsors to propose labeling that sets forth the results
of in vitro, pharmacokinetic, clinical abuse potential and formal postmarket studies and
appropriately characterizes the abuse-deterrent properties of a product.
There are several important concepts about the state of the science of pre- and postmarket studies
of abuse deterrence that should be considered as these are reflected in labeling. First, as stated
earlier in the guidance, abuse-deterrent does not mean abuse-proof. Therefore, labeling should
reflect a product’s abuse-deterrent properties, as supported by the data, but should include a
caveat that abuse is still possible.
The following passage refutes claims about Nasrat "lied" about not needing a P3 study....again straight from the FDA
The results of Category 1 studies may influence the design of Category 2 pharmacokinetic
studies and Category 3 clinical abuse potential studies by suggesting the methods of
manipulation that would yield the greatest release of opioid. The results of Category 2 studies
may influence the need for Category 3 studies of clinical abuse potential and the designs and
goals of these studies. For example, if the extended-release characteristics of an abuse-deterrent
opioid formulation cannot be defeated and the pharmacokinetic profile remains unchanged
following oral or nasal administration of the manipulated product, oral and nasal studies of abuse
potential may not be necessary.
straight from the FDA'S own 2015 Industry Guideline for abuse deterrent formulations
The science of abuse deterrence is relatively new, and both the formulation technologies and the
analytical, clinical, and statistical methods for evaluating those technologies are rapidly evolving.
Based on the evolving nature of the field, FDA intends to take a flexible, adaptive approach to
the evaluation and labeling of potentially abuse-deterrent products. Methods for evaluating the
abuse-deterrent properties of new molecular entities may have to be adapted based on the
characteristics of those products and the anticipated routes of abuse. The development of an
abuse-deterrent opioid product should be guided by the need to reduce the abuse known or
expected to occur with similar products.
Because FDA expects that the market will foster iterative improvements in products with abuse-
deterrent properties, no absolute magnitude of effect can be set for establishing abuse-deterrent
characteristics. As a result, FDA intends to consider the totality of the evidence when reviewing
the results of studies evaluating the abuse-deterrent properties of a product.
Whhhhhaaaaaaaat!?!?!?!?
You mean to tell me that Eugene Pfeiffer was "more than likely" brought in for JUST THIS SCENARIO!?!?!?!?
Plan B
Enter Eugene Pfeiffer.
Go get em Eugene
THIS IS WHAT ELITE SHOULD BE ASKING THE FDA
Is SequestOx more dangerous than currently approved non adf ir oxycodone because of a fatty meal?
Is SequestOx a better alternative than currently approved non adf oxycodone due to it being an actual abuse deterrent?
Thanks. I'm no rocket scientist but geez. The FDA wants to curb an epidemic or end it but yet do nothing in the end to help at all.
Thanks for your insight. I just wish others would stop and think about this too.
To each their own
Glad to have you back. Go get em champ.
Eltp baby
Very excellent DD. Everyone needs to stop and think. While it is always best to have a questioning attitude toward this some times we can get so enveloped and tunnel visioned that we don't know what to believe.
The silence doesn't help but I wouldn't expect anything different. We all want answers and demand the CEO "come clean" but we just need to be patient.
I know easy for me to say I have not been here as long as others....by a long shot.... but this can and I belive WILL be overcome with FDA approval with a labeling revision.
The FDA wants ADF opioids. Risk/reward benefit of having opioids with ADF far surpass the current NON-ADF opioids currently being prescribed.
Just my 2 cents
It would still be a drug that is being pushed in the USA and still making it a matter of "material information" that should apparently be made public.
How am I mixing up IR OPIATES with DETERRENT IR opiates?
The both are addictive. One deters from abuse via manipulation (except for swallowing) and the other is what is causing the epidemic by allowing anyone who wants to manipulate the drug into ways of selling on black market to make money or to get high.
I'm not mixing them up
Lasers......you mean to tell me another company keeps "material data" from shareholders?
Say it ain't so. So we as shareholders aren't privy to ALL "material"
Then why would the FDA want ADF opioids as soon as possible? They are ALL unsafe because even ADF opioids can become addicting.
You just made my point for me.
Just what is the FDA really trying to do to stop this epidemic if they are so concerned a person who takes the pill as prescribed has a delay in TMAX by (X) amount of time?
One more thing I would like to point out that I thought about whilst I was at the pool today.
So as of right now today....there are ZERO IR OXY with ADF label on the market AT ALL.
The whole point about the FDA moving away from and phasing out NON-ADF opioids is to make them "ABUSE DETERRENT" and at least curb if not end this "opioid epidemic". There is no such thing as abuse resistant drugs no matter if they are opioids or any other commonly prescribed drugs that are subject to abuse. The current market of such NON-ADF opioids are just that. Easily abused and manipulated in order for a person to use as not intended.
So how can the FDA sit there and say we have an epidemic of opioid abuse and deaths caused by opioids but have a bar set so high that NO company has been able to hurdle to this date. Big pharma or Elite! So here I am thinking that the FDA wants ADF opioids to stop an epidemic but don't want to approve ADF opioids because they fear that someone not smart enough to read a label or to follow directions "might overdose". The whole point of ADF opioids is to phase out opioids that are easily manipulated for purposes of ANY type of Misuse other than for SWALLOWING a pill as intended. So instead of perhaps having a "labeling" issue , since the purpose of design is to stop manipulation, the FDA wants to continue to allow the current drugs on the market which HAVE NO ADF whatsoever be sold and bought and then sold and bought on the black market.
So my rant here concludes with this question. Just what is the FDA really trying to do to stop this epidemic if they are so concerned a person who takes the pill as prescribed has a delay in TMAX by (X) amount of time? It would seem as though if the FDA truly wanted to end the epidemic or even curb the epidemic that they would be willing to accept the risk/reward benefit as such in the mean time to start phasing out these easily manipulated opioids on the market today.
Seems to me the bar HAS been set a little high for ANY company to over come and yet what does that do for the epidemic?
Nothing at all. Status quo for the epidemic that claims 44 lives per day. Silly if you ask me. But that's just my own rationale to this.
I agree with you jimmy. Today's sentiment and accusatory stance is just I feel people's rationale to expect the worst.
One thing I would like to point out and every doctor here should be able to tell you is the FDA does NOT allow a pharmaceutical company just do whatever they want to do in regards to trials and studies to get a drug approved. The FDA sets guidelines and protocols in which the company must follow.
Elite and Camargo didn't just get a wild hair up their arse and just blindly did what they thought was best. The FDA is involved EVERY step of the way. They oversee everything from the IND or request to start a new application for a drug all the way to BEYOND the approval in which they do further studies after approval just to make sure the safety and efficacy is still intact. I believe it's called a REMS study.
The FDA calls the shots from day one and the company must follow those shots otherwise they would NOT be granted approval to move on to the next phase or trial or study in the drug process.
Correct? So seems as if the FDA told elite to move forward every step of the way and now has had a change in mind. Now maybe it was due to the avridi adcom and that maybe Nasrat has had communication with FDA in which he thought he could resolve this post avridi adcom in order to still get it approved. But NO ONE knows this but Nasrat and his team.
My apologies. I see now my mistake. Sorry
The psychological response when faced with adversity. Fight or flight.
May I ask a question?
Why would we initiate a legal action if they have no legal liability but a moral one?
I mean I feel people are again jumping off the deep end. But everyone is entitled to their opinion.
Today seems like a good day to keep my mind busy and off eltp. Especially the MB if this is what today is going to be like. Sorry to be so blunt
Nope. Not what I meant. And your post clearly shows what I meant.
You only quote people's words on this message board. So by ammo I am referring to what we say on here is used against us to fill your personal agenda.
I have always been open to hearing both sides of the spectrum have I not? I welcome your thoughts and facts if you have some that back your sentiments. And just like anyone else here. I would rather hear what's wrong and right in people's minds so that way I may personally form my opinion one way or the other.
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.
While I agree all we can do is draw comparisons but we are in sort of uncharted waters here. There are no approved FDA IR oxy with ADF to compare to. Then throw in the fact that these are 2 different AD formulations. There is a lot of information that NONE of us have that just because we feel MAY be "material" in our minds doesn't make it that. Even though we have doctors on this message board and people who have good institutional knowledge none of us know what the company knows. Just like your commentary I take with a grain of salt but I always like hearing BOTH sides of the spectrum even if there isn't a link or fact to back it up. Because it is on me to form my own opinion on what may be true and what may be false.
Weezuhl obviously is concerned and was willing to share what he found. But I don't think anyone is questioning his integrity. We all want answers. Well some of us anyway.
Well I can see how today will be here on the MB. I understand everyone is concerned due to the CRL and want or demands answers claiming this or that is "material information". But if you look on FDA'S website material is not made public until the drug is either approved or sent to an adcom for review since the adcom is a public forum. I think this Avridi information is valuable in the sense that it can be a reference point HOWEVER the two drugs are not the same. Agonist antagonist versus a gel/detergent formulation.
One thing I'd like to point out I'd the "liking scale" being so much better. What do you expect? Sequestox has no design to give the potential abuser an adverse effect if manipulated such as burning sensation or soapy taste. Sequestox simply just neutralizes the euphoria and "high" be blocking the receptor that the opioid binds to. There is NO adverse effect that the patient would score lower than "nuetral" or "50" because again there isn't something in the formulation that would make someone "dislike or hate" what it does to them.
Avridi certainly does with burning sensations and soapy after taste. So why wouldn't their "liking" score be lower or "best I've seen before".
People while it is always best to do DD and try to draw comparisons to and help weave our way personally through this CRL. But I personally don't think that demanding the company divulge information or "material" is going to help any of this get dealt with faster and or approved faster. The only thing people are demanding is self preservation in order to sell and walk away.
If you feel that this is a scam then do sell and walk away. It's bad enough people will only quote long term investors to try and prove a point but giving them ammo certainly doesn't help either.
Like always I am holding. Because I feel people are over reacting to this. Rightfully so to "educate" ourselves but demanding the CEO for information and the company k ew this or that is no better than any other opinion on this board. Like some one earlier said. It's best to allow ELTP and FDA to figure out a way to move forward. Doctor or not a doctor on here none of us have the knowledge to tell the company what it needs to do or how "we can help".
I think if this morning is any indication of how today is going to go I do believe I will not be following g the wonderful commentary today.
Everybody take a deep breath for crying out loud.
Then I guess the "not knowing how long if ever" clause was just answered by saying which class we are in. 2 months or 6
You make it seem as if sequestox will never be approved. As unfortunate as it is this isn't the end of the world. A rejection would have been given if there were no path to approval.
Just have to stop and look at the bigger picture.
However despite past precedence it would be a slippery slope for Elite in the fact that seeing how a pipeline of drugs to come it might be a bad idea to put a bad taste in the mouth of the FDA.
Sort of like the saying, "don't bite the hand that feeds you"....
Applesauce that is. Lol. Sorry I had. That was for you guys Dr. Low, Nam and John Lang
That's why I personally think Eugene Pfeiffer is about to earn his keep.
Yes I think we all agree with the "no love" from FDA. While a valid concern they bring up its hard for me personally to not have some sort of small "conspiracy theory" that FDA was maybe looking out for other interests other than elite.
But I think everyone who is PRO ELITE here knows whether there is truth to that or not we have to focus on what the FDA has said and address it one way or the other to obtain approval.
Labeling or BE study. That's where we are. Thanks for your input. It's much needed around here.
"ALTERNATIVELY EMBEDA MAY BE SPRINKLED ON APPLE SAUCE"
Embeda Dosage and Administration
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a7658a2d-b7a9-4fb5-8d65-a20ca1b9ad1f
INSTRUCTIONS FOR USE demonstrating the sprinkle and apple sauce.
And I will even say this....in Embeda's labeling/instructions/packaging it talks about even "not to chew or crush the beads" after "sprinkling" because of essentially dose dumping and blah blah blah ....
Let me see if I can find the post someone wrote.....otherwise someone my twist what I just wrote.