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I agree. It was in a round about way responding to someone who says fda doesn't want to approve a drug unless it can deter against oral (swallowing) over dose.
Simply "nonsense"
THERE IS NO, ZERO, WAY AT ALL TO HAVE AN OPIATE BE DETERRENT AGAINST ORAL (SWALLOWING) OVER DOSE.
NO SUCH TECHNOLOGY EXISTS. EVEN PRODRUG FORMULATION CAN NOT PREVENT THAT WHICH USES ENZYME OF THE STOMACH TO ALLOW OPIATES TO BREAKDOWN AND RELEASE FOR PAIN CONTROL
PERIOD
SNUP,
I love your always cheerful and positive messges. One thing that I would kindly disagree with you on is the need for print and exposure.
The reason I say this is prime example this morning. "News" apparently came out about ELTP and really it was just a blurb of comply and paste about the CRL and a dodgy attempt to make it "seem" like our ceo said those words. Some people are wanting exactly that. Fluff news pieces that allow people to scrutinize every aspect of the news. It's bad enough that Elite is in the position it is today whether we want to blame the FDA/big pharma or solely Elite. However there is always 2 sides to every story. It's up to people to TRY and see things for how they really are to the BEST of THEIR ability. Whether it is "connections" "friends in high places" or "institutional knowledge".
But since Friday I have been on a Rollercoaster ride of emotion. What I think would speak VOLUMES above any PR or NEWS or details about this or that is strictly for Elite to shut up or put up. I don't care about 6 submissions over next year and a half. We and Elite need to focus on Sequestox.
I just like everyone else in here is in it to make money one way or the other. But please do not mistake that given the current "morale" around here because of July 14th the last thing we need is more things that can allow someone to pick apart and find "holes" in what's said or released.
FDA approval for Sequestox is bar none the MUST important priority right now.
No more Fluff pieces or PR that can be dissected into negativity.
Just my opinion.
Those words were not spoken by the CEO. As noted by NO quotation marks surrounding it.
So your source is not valid as it is someone's opinion and not of factual evidence.
Besides their ability to write and use proper words or diction is horrible.
Elite pharmaceuticals did not say that.
Thanks MRW
So IF it's class 1 up to 2 months from "resubmit"
And IF it's class 2 then up to 6 months from "resubmit"
So depending on the CRL and how the FDA deemed the class notification is how long we could expect.
That is assuming that the amount of time up to "resubmit" is (X) amount of months.
So my point is that when Elite notifies the share holders of a "resubmit" to FDA for 2nd round approval those time frames are arbitrary in the sense that it is not set in stone but have the ability to take UP TO 2 or 6 months.
However if elite can stay in "constant communication" and the review could be a matter of verifying all is suitable for the FDA:
The approval would come randomly and not by any "given" and "announced" date such as the way a PDUFA date.
Meaning once elite resubmits then it is just a matter of FDA "getting around" to say yes or no. And at that time IF it is approved we would be notified by PR from Elite or could see it randomly on FDA website.
Correct?
Somebody correct me if I'm wrong but when the issues are "fixed/satisfied" and Elite resubmits for 2nd round approval there is no date given by fda and that merely upon review of the information given the fda will either approval or CRL.
However crl would directly go against the whole purpose of crl for this second attempt. Because why issue a CRL with what the company needs to do, meet with them, and then CRL the application again.
So assuming the CRL is satisfied, upon resubmittal to FDA for approval in round number 2, the decision could come with NO ONE'S knowledge except for a PR.
That is unless you have "inside information"
Yoda
That's a very valid and awesome point.
Viagra is nothing more than a vasodilator that allows your vessels and arteries to open and allow more blood flow to the you know what. And with vasodilators a rapid drop in blood pressure due to the dilation could be deadly and have severe consequences if misused or taken recklessly.
It has a side effect of lowering blood pressure because it relaxes the muscles of the heart and again opens blood flow through the the body. So where a person not on viagra would have a blood pressure that is normotensive to them takes a dilator and lowers the amount of resistance to maintain blow pressure but also allows more blood to flow. That's why they say may lower blood pressure and too much exertion could lead to an adverse outcome.
Boy if that could be the case where simple wording would allow it to pass. The only downside is that people aren't abusing viagra in the volume of opiates. And given the high profile deaths due to opiates versus viagra it would be a stretch to say that would suffice.
But maybe. Absolutely just simple common sense wording is what "should be needed" not more studies or worry of people overdosing via oral consumption because they can't follow directions.
I will say this....if the FDA says you can't meet with them for 30 days why would you need to meet with them if you could talk on the phone. I'm trying to understand that. And if there is proof a company can call and talk to the FDA regarding the CRL what is the meeting for? And please provide a link or actual quote stating they can have contact back and forth prior to 30 days.
Thanks in advance. Not trying to stir up trouble but trying understand the conundrum of 30 days rule.
Yeah I would say not bad either. Considering all things possible. The CC definitely helped a lot in that cause. I just hope we can sustain this level and maybe inch back up on some days. Starting with the next CC in August, 10Q , and perhaps some sort of PR regarding the meeting with FDA.
Come to think of it. Perhaps they should push back the next CC a few days in order to incorporate the FDA meeting as well. But I'm not the boss.
Congrats
Hey John. How did you do today?
What were your thoughts on the CC? We're you able to listen to?
Pretty positive if you ask me. Direct to the point and moving forward.
Plus the pricing did a lot better than many here predicted.
August CC and quarterly filing showing the revenues from the generic opioid that wasn't reflected on last quarterly.
So by going above what the FDA wants is now all of a sudden not following protocol?
If FDA says 30 patients but doing 100 is bad?
Lol
WOW I CAN'T BELIEVE HOW MUCH DILUTION IS GOING ON TODAY.....
I mean 2pm and only 18M shares.
Less than 5%.....
Look out everyone. They said there would be soooooooo much dilution.
I don't see it do you?
BTW THAT WAS ALL SARCASM IF YOU COULDN'T TELL
But the only thing I say with that is. To get a truer sense of statistical data obviously the higher amount of patients the better accuracy in the data and statistics.
Sample sizes is what I'm getting at.
I would want to go above and beyond as long as time is not going to determine how much longer it would take. I guess what I'm saying is ME personally would like to , IF needed, double or triple the size to take back to FDA and throw it at them so they can't say it wasn't enough. Just like what NH said of doing a study and they say it wasn't good enough for them or "change their minds" again
Lol I'm telling you the one liners and zingers are great.
Thanks doc low.
Yes but p3 was 163 people over several cities.
Lol. You act as if getting 100 or so people is difficult.
Come on really?
How about answer my question....
How long did the p3 take that they did in 2015?
When you answer me I will answer you.
I disagree with the time frame slightly.
30 days to speak to fda.
IF they say we MUST do another study.
We are looking as 2-3 months from start to finish for new 100+ person trial with sequestox and a fatty meal.
From the day the trial is finished which is included in the 2-3 month time frame the science and data should be scrutinized with long hour days. Pouring over the data and getting it ready for presentation purposes. Then resubmit to FDA.
From the resubmit they should not have to do an entire review process like the first time. Essentially reviewing the "added information" they wanted. Then let's say 30 to 60 days for decision...again.
Now that's all assuming an additional study MUST be competed. Hopefully fda will not require it but simply negotiate with elite on wording on label/instructions.
I can see another decision date very late 2016 very early 2017.
ALL JUST MY FRIGGING OPINION.
Well sorry for the harsh words over the weekend. Glad you are smarter than that and still here.
We will all be looking good over the next 1.5 years starting with sequestox getting over this little mole hill. Not mountain.
I wish I had more money to buy in however I took a risk buying in pre-decision and I was on the wrong side of the coin flip as snup says.
Catch 22.
Waited to see if fda approved and I could have chased the price up. So I bought as a long term hold regardless of desicion. Or could have waited for CRL and doubled my share count and made money today and never been down to begin with.
I just wish I didn't have money to average down and lower my entry point.
But such is life.
Thanks and Elite will be juuuuuust fine
Didn't a lot of us try to tell you that this weekend? Not to panic?
And yet some people told you to sell right at the opening bell.
Glad you didnt?
Now that was funny. I don't care who you are.
I think it's gold. Maybe elite should hire you as their sales and marketing manager.
Get your applesauce here!!! Ice cold applesauce here!!!
Good one doc.
Keep them coming. The one liners that is.
Ummm yes it was. Again if you can find me saying that please show me.
I enjoy your commentary and love the challenge but let's not make false accusations towards each other.
Come on doc. I never said that. I was NOT the one to say Nasrat was speaking to the FDA over the weekend. I KNOW that after the CRL it takes 30 days before you can speak to the fda.
Let's keep it real. If you can find ME saying that please show me.
If the FDA says relabeling is not sufficient. Then yes I agree another study required.
However we won't know until August after fda meeting with elite.
Yes I agree. "PASSION" is a very accurate way of describing it.
Not only did he say sequestox will prevail , in the best way he could, but he said we will not just take this on the chin we will fight back and submit a new NDA or ANDA "ONE EVERY QUARTER STARTING Q3 UNTIL END OF 2017"
TAKE THAT FDA
One thing I was impressed with the CC was the stern and direct message he spoke with. I have never listened to him speak other than today. I have only read transcripts of other conference calls.
I think he was sending a message with how he spoke that he was very dissapointed the FDA did this. He was straight forward. No sugar coating it and laid it all out on the line.
Thoughts anyone who is actually invested?
Wow. I can't imagine what 30mg would feel like. My Norco was a hydrocodone APAP combo. With only 7.5mg of hydrocodone.
30mg is a lot!
7.5mg made me feel good and I guess "buzzed" if you will. Nothing over the top but enough to take away pain.
I have recently in the last year exactly have had ACL reconstruction and a rotator cuff tear. Both times of which have been prescribed Norco for pain. The label on the bottle has simply said take one pill every 4-6 hours OR as needed 1 hour before eating.
Now I never took out the entire packaging instructions to read all the scientific and lawyerese in it but I would think it's a matter of labeling and instructions to cover the "safety concern" the FDA brought up.
Nothing more IN MY OPINION....
I agree. Further study is NOT needed. FDA needs to understand people have ultimate responsibility on how they follow directions
I would just like to add something that should ease people's minds hopefully about the state of the company IN MY OPINION....
So on Thursday and Friday it was said that there was HUGE market pressure and that the amount of HUGE volume was proof of such CRL coming.
I would like to point out that Thursday and Friday each day had roughly 4M per day of volume. Even today after what I think was a good conference call the volume is still very low. Sure we can say 12-14M before lunch.
But fear of dilution should be evident. Even if we trade 20M to 30M shares today that is roughly less than 5% of volume compared to the OS.
This is a good sign in MY OPINION because it wasn't the end of the world like some people on here were acting like. It cited the things that needed to be further addressed either by sitting down with FDA in approximately 30 days and tweaking the labeling or run a quick 100+ person study of fatty meals to observe the response rate.
But again IN MY OPINION doing another study would be pointless. The data will not change if someone takes a pill outside of the directions given. And even then if a person eats a fatty meal that there could be a slowed response. Doing another study in my opinion would reveal the same results.
So IN MY OPINION it is a matter of sitting down with the FDA and talking about the issue of people's personal responsibility with taking this drug.
Any one have thoughts? Ok...Wait a minute.....anyone have VALID thoughts and that is not twisting words. Thanks
I think end of year approval is very possible.
The study is just a matter of enrolling 100-200 people post surgery like the bunionectomy and about a week's worth of trial data needed with fatty meal and then review results prepare it for fda and resubmit
Just to make sure people know I'm not here to PUMP and run. I am holding my shares.
I feel this will and could still be approved by years end. The study should not take long at all. Once all people enrolled it's a matter of a few weeks to get results. Then review data and resubmit to FDA
IF THAT'S WHAT FDA SAYS NEEDS TO BE DONE.
Or Elite can talk to fda in 30 days and agree to better labeling and packaging
ALL MY OPINION
Safety in regards to oral overdose.
How can you stop someone from overdosing orally?
PC world indeed. We have to worry about everyone who don't know how to follow directions otherwise someone will say "they didn't tell me that" and sue
It's all good. I called in. Thanks
Does anyone know if there is another way to listen to the CC other than calling in?
If not I guess I will either have to try and call in and hope I don't get interrupted or just wait for the wonderful commentary afterwards/transcript?
Also from FDA'S process for NDA application
The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following:
Is the drug safe and effective (efficacy) in its proposed use(s) when used as directed, and do the benefits of the drug outweigh the risks?
Is the drug’s proposed labeling (package insert) appropriate, and what should it contain?
Are the methods used in manufacturing the drug (good manufacturing practice [GMP]) and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity?
Sound similar to what Elite just might be going through right now due to the Epic/Puracap/humanwell issues as of a few months prior to PDUFA date for Elite?
FDA'S actual process in which it takes for all NDA applications.
Once the application is submitted, the FDA has 60 days to conduct a preliminary review, which assesses whether the NDA is "sufficiently complete to permit a substantive review." If the FDA finds the NDA insufficiently complete (reasons can vary from a simple administrative mistake in the application to a requirement to re-conduct testing), then the FDA rejects the application by sending the applicant a Refuse to File letter, which explains where the application failed to meet requirements.[6]
Assuming the FDA finds everything acceptable, they decide if the NDA needs a standard or accelerated review, and communicates acceptance of the application and their review choice in another communication, known as the 74-day letter.[7] A standard review implies an FDA decision within about 10 months while a priority review should complete within 6 months.[8]