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What is the verdict now being 2 years later?
I actually prefer limericks.
There once was a man named Nasrat...
I wouldn't be surprised. The entire team during the conference call should be able to see who is in the pipeline of questions and can select who you want to respond to or ignore or cut off.
I agree with you there. More reactionary and less forward thinking. I think it is a hard lesson learned, but will be far better that it took place in the end.
You are exactly right in the fact that a CRL was received. I do not believe the CRL will hold up the tech from progressing to market. I think the CRL was best for the company in the long run to get the product right before it becomes cancerous to the brand and entire pipeline of what is still yet to come.
From the commentary over the years Nasrat likes to do business with those he knows from lives past, regardless of how small the company they may be at today. His trust in people is strong. Not sure I trust the size and resources of those organizations though to fire on all cylinders.
I believe CEO also stated in a subsequent call that all points regarding manufacturing warning letter have been rectified. No longer an issue.
Maybe. I didn't connect the dots in the commentary back then and the lack of Q&A doesn't help when follow-up clarification is warranted. Could also be a crappy transcribed script, which is not rare.
Q3 2016 call CEO stated:
“The clinical results for SequestOx, now that we disclosed what the product is, will be presented at various pain conferences this year. So far we have two -- possibly three lines up for these presentations act. We have now announced that SequestOx, ELI-200 are oxycodone, the current market for the generic part is $400 million.”
Why would he reference the generic market potential? SequestOx will be a branded IR. What am I missing here?
May not be first, but they have a solid product unless May results say otherwise. There will be better tech in the future, but I think this will be best available tech for a few years.
Was in one of the cc scripts. Forgot about it and refreshed my memory on several points last weekend. I'll track it down and use direct quote & reference.
Agreed. I think the hype here defies reality on both sides of the spectrum. There will be no hammerlock, but then again there will be no bankruptcy either. Good things are comin' round the mountain.
My point was that despite what some say here, SequestOx, if eventually approved, will not come close to owning the IR market.
One surprising note is that Nasrat stated SequestOx has 400M potential in sales. Caught that when reading prior call scripts. That is a small potential for a dent in IR, but not huge.
And you think that because they have lawyers that there will be no litigation? I would gladly like to see that. Not gonna happen though.
I accessed the PRs on my phone 30 minutes ago. You make hot need to reset your cache.
How long it will take litigation to clear is a good comparison to what Elite can expect down the road. I expect more than one pharma to file suits to put a pause on any sort of launch.
So what? More frequently does not negate ER altogether.
It is ER, but incredibly slow ramp. Wake up. Same has happened to all approved ADT products so far. Incredibly slow adoption.
Stock decrease has coincided with equity offerings. Half of company's 300M valuation is from 150M in the bank.
Here is info about Collegium's Xtampza: UnitedHealth will make Xtampza exclusive from Q1 onwards, at the expense of OxyContin.
Xtampza is expected to bring in 50M or 1% of potential market by end of 2017. Company burns 100M cash per year so plenty of expense to cut if sales don't materialize.
Xtampza ramp rate of scrips is eye opener for those that think SequestOx will "own" markets overnight. Not a chance.
Why then would Nasrat say it will not be applied to the industry? The industry is inclusive of other pharmas and their IR products.
I get the ER vs IR, but IR is not just an Elite issue. That is what I am hung up on. Any pharma with a potential ADT IR product would be held to this bar if that were the case. May just be funny wording, "ER or rest of industry". That is solely focused on Elite.
"So this is not an issue that the FDA is going to expand I believe to ER or the rest of the industry. It was a unique thing in this very specific case that they thought about two years after they give us green light to move forward. So there will be no real formulation for any of our ER products or anybody in the industry that for the reasons I just explained.”
Perhaps, but I don't think so with the wording mentioning it won't be extrapolated to the rest of the industry, but only to Elite's specific case. We are lacking some details & analytics as to why this is the case. Elite is unique here for some reason.
If this only brings five-fold I will be sorely disappointed. Plus, no insiders sold at $0.90 so I will take that as a positive sign.
Stock is struggling, but company is tackling the issues at hand with a solid plan. I have no doubts on the future of the company. Trajectory may strengthen further with Fed BE results next month from SequestOx.
That is a comment from 2014. Super old news and has since been replaced at least 5 or 6 times with the following comments. Organic growth is plan A, but if not working, reverse split is plan B. With CEO's commentary on wondering why stock hasn't moved on SunGen or Oxycodone generic news, I think he is leaning more and more each day towards plan B to get off OTC.
Q1 2016 Transcript
Nasrat Hakim,“And uplisting to NASDAQ is on my mind and I’m planning for that for 2016. There is a lot to plan and to execute before we get to that point. I do not intend to do that unless we have the fundamentals and those fundamentals are followed and the timing is correct. A reverse split may be required, but as I said we are not ready to make that decision yet.”
Carter Ward, “As far as what you mentioned regarding the stock price, I’m with you there, I hate the reversal split and I do believe in the fundamental before you get on NASDAQ but anywhere else. But if we do not do it in a timely manner, I don’t want to hang around the bulletin boards for the next three, four years. We will do something to get us there.”
Q3 2016 Call
On RS, “And finally, forward update. NASDAQ keeps coming up and I have the same answer, the ultimate point for me is to get Elite to the NASDAQ. We’re not going to rush in to anything but we’re not going to sit around and take forever. I would like to get to NASDAQ by organic growth and if it does not happen, we will do it with a reverse split. My preference is the fundamentals, and we will not do it unless we have fundamentals. And that’s really the guiding principles right now. So our other generics and SequestOx hopefully will provide the fundamentals for us to make a smooth transition to NASDAQ. As I said before I do not prefer having a reverse split but if we have to, that will do. We are at least a year away from that decision and we will discuss it in future conference calls.”
Q4 2016 Call
“I am hoping for an organic growth and that will probably take three years, and don’t have to do a massive reverse split, but realistically on the rate we are going, my gut feeling and this is just an opinion, I would say two, three years.”
Q1 2017 Call
NH, “Our ultimate goal is to have a strong enough fundamental to go to NASDAQ with as much organic growth as possible.”
NH, “I was hoping to marry this with SequestOx once we get approval for SequestOx and launch or file all of those generics, that will take us to the next level where we will be ready for NASDAQ, a little delay that is not going to hurt us. The plan is simply to go to NASDAQ with as much organic growth in minimal stock split. This remains our plan.”
Q2 2017 Call
NH, I would love to get us to NASDAQ organically. If I can, I have no issue with supplementing that with another method such as stock split, but really the preferred method always is for us to try and get there organically.
I know where our stock price is, and I know where it should be.
Q3 2017 Call
Not an issue FDA will expand to ER or any others in industry. Specific to Elite only. Here are CEO's words. I may be misinterpreting, but don't think so.
Nasrat Hakim, “The reason that they - the FDA made a big deal about the Tmax in our case is because there is a delayed effect when you take oxycodone with food. That is also to even for the brand oxycodone. Historically, the FDA or the Doctor and the pharmacist will tell the patient to take the product an hour before food or two. The FDA is thinking if somebody eats and then they are in pain, they don’t get the effect within 20 minutes, then they go ahead and take a second or a third dosage and end up with that. This has never historically been the FDA's policy or anybody's policy because usually you take rescue medication, you will take in case if you eat and you cannot take oxycodone, you will take a prescription strength Ibuprofen, okay.
So this is not an issue that the FDA is going to expand I believe to ER or the rest of the industry. It was a unique thing in this very specific case that they thought about two years after they give us green light to move forward. So there will be no real formulation for any of our ER products or anybody in the industry that for the reasons I just explained.”
But that is 100% guess. We have no idea on the number of competitors, pricing, etc. There is no reasonable way to make any logical assumption at this point on 4 SunGen products.
I don't ever recall a $1 threshold.
I remember it being a vague comment. I will look up quote so as to not paraphrase.
Funny that I recall Nasrat saying that the additional studies would only be required for SequestOx and not products from other companies. This is all ringing in my ears wondering what the FDA can see that is slowing down the product compared to a clearly flawed product such as RoxiBond. Intriguing to say the least.
That is hilarious and yet fascinating. Guess patience really is a virtue.
Perhaps they feel addicts couldn't wait 30 minutes. Ha!
The FDA is privy to much more data than the public shareholder. Until we actually get an Adcom meeting, when more data becomes available, we will have more insight. Remember, it wasn't until we received the CRL that there was a risk of overdose under fed fatty meal conditions. On that same premise, what else do we not know about?
To assume that Elite keeps getting the shaft is an emotional viewpoint. There is some data or some aspect(s) I am blind to.
Assuming approval for RoxyBond with 2 out of 3 ADT labels, how does this affect labeling potential for Elite & others?
Months or years, rather than weeks. Not even close to selling the company.
Wow, interesting. I think this says there is much more to Elite's data than we are led to believe. Unanimous vote for approval. Crazy.
One has not been executed, but it has been mentioned as a possible route to NASDAQ listing if we cannot get there organically. Over a year ago it was said that a decision will be made at least a year out. We are beyond the threshold based on the CEO's comments.