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I think after market close is my guess.
Auditors have to sign off prior to the 10Q release. I am sure it was wrapped up early to mid last week to allow time to analyze & prep associated commentary.
Have you seen typical splits? I would be interested in hearing you actually do some research on this. 50% split is far from realistic as well.
*revenue
Aren't they in a recenue share agreement with Epic for Eli-200? I can't imagine their share would be anywhere near your topline figure. I see Elite being the manufacturer for some products, but not developing a sales staff to reap all topline benefits.
Based on market cap. I worked for a company that became an accelerated filer. Market cap was determining factor.
The only reason for the record figure last Q was due to the $5M payment from Epic. It was not driven from ongoing operations. It does, however, buy a little more time as Elite will get another similar payment during this quarter for NDA submission. I am not expecting anything fabulous this quarter, but am much more interested in the bigger picture of what is to come beyond ELI-200 during 2016. An earlier submission than end of year would be good news, but not counting on it.
In recent investor conference the CEO stated that top line results are "hopefully" going to be released in October. I read this as last few days in October or early November.
Webcasts are typically for presentations, not video of the speaker. I'd expect potentially scientific education, pipeline update on timing, business strategy update & selling us on the future potential of what is to come.
I just left a position where I managed a $100 million/year capital budgeting program. Not all intangible assets are amortized. If it has a definite useful life it would be; however, there are some intangible assets (e.g., brand related) that will forever remain on the books and are not amortized.
I know what a CTO is, but you haven't said whether it would exclude any communication from the FDA. That's what I'm looking for as to whether there is anything they could potentially hide in relation to the FDA to prolong communicating it to the public a little while longer until another study has been completed.
My first impression is that the FDA is that there were issues with one of the studies, but I wouldn't think they could use a CTO for that. Thoughts?
"Development of our abuse-deterrent opioid technology continues to be Elite's top priority and we invested $4.0 million this quarter for a human abuse liability study, bioequivalence studies, and other product development activities. Elite remains on track to file its first abuse-deterrent opioid product, ELI-200, by the end of calendar 2014."
Just curious but how is the delay not Elite's fault? The above statement was from a prior cc. They were "on track" about 6 months ago. The trial would have been completed by now had they actually been conservative with their assumptions. They took on huge risk of assuming the FDA wouldn't need one and realism brings to light that a PIII would be required. What was the risk? Losing out on a year of revenue in a multi-billion dollar market. Pure incompetence. Shame on the other senior team members or Board for not doing their job. Always better to over than under prepare.
I was hoping there would be some comment or inclination as to the outcome of the FDA meeting. Nada. Not sure how to take that as it was clearly written prior to Monday's meeting.
Yes, I agree with your comments and made a similar post on Yahoo Finance. This is based on my years of my personal experience with companies posting after hours on Friday. I cannot recall one instance in which it was good news.
The delay for the call could very well just be travel schedule coordination. I wouldn't read too much into the delayed call on Wed. You're grabbing at straws otherwise.
In the same PR.
I think the actual submission will take place in December. We will hear back in February whether we have been granted priority review.
That is incorrect. One study shows the average being 7.5% as a royalty fee on sales or 25-30% on profit. Milestone and upfront payments muddy the waters even further. The PPS ''analyses'' here are so out of whack with reality. Let's quit doing Obama math here.
I believe you are assuming ELTP doesn't partner which is an erroneous assumption. In partnering will we get 5, 10, 15% royalty on sales or profits? Definitely not 100% and we know Nasrat had said we are targeting a partner by end of year. Also, your PPS is built on total sales (partner) and not ELTP profit so divide the number of ELTP royalty by about half. That is the starting point.
Until we know more it could be either for the FDA filing or any additional FDA requirements prior to the filing.
Look at AMSC's history for one when the CEO bought boatloads on the way down. Been underwater for several years with no hope.
Most companies dont release news until after FDA minutes are released. Why is everyone expecting news in October? Even Nasrat in last cc said next touch base will be in November
Minutes from Oct meeting can take up to 30 days to be released. I would think it would be a risk for Elite to release anything about the meeting prior to this. They might not even be received until after the next cc in mid Nov. I woild expect to hear about the Full HAL study this week or next week.
To date, scientists have not been successful at obtaining more energy from water splitting than is put into the process. The theory of this technology has been around for years, but is still a dream away.
It is October 3rd. This is still an acceptable window. If we get to November 3rd then you can be impatient, but not until then.
I agree with your comments here. I also wouldn't be surprised if we held off on a partnership deal until early next year. This is one deal we do not want to rush.
There's still some leverage in the partners hand if we do a deal prior to FDA approval. Even if we get delayed 6-8 months we obtain much more leverage after FDA approval than before.
However, partnership deals can take several months and we'll want to ensure we can hit the ground running upon approval (when it does occur). This requires a fine balance within the contractual framework to take into consideration the potential scenarios.
The potential for the partnership is huge as we're going to be pushing several ART products through over the next few years. Very exciting.
What needs to be proven about the valuation? The market moves don't always make sense or value stock prices on true intrinsic value. Those are true stock buys with great potential.
And what could any lending institution have used as collateral? There is no inventory to liquidate, no bank in their right mind would use a letter of credit, there certainly wasn't any cash flow for that type of corporate loan. Again, the LPC deal was the ONLY logical way this company could have raised the needed cash. Based on my expertise of managing corporate liquidity I cannot determine any other option that they had.
In all reality the LPC deal stinks in the near-term as the float increased to the nth degree, but what it really did (and I'm preaching to the choir as you already know) it gave Elite the POTENTIAL to pursue a real product pipeline for real long-term growth potential in very large markets.
The real question is was the LPC deal worth it? The FDA's response in October will tell us all. Is there going to be a near-term delay for an additional trial required (quite possible) or will there be some major obstacle currently being overlooked?
Please kindly share what other logical ways could Elite have invested in the ART products apart from the LPC deal? This was by far the best way to go to meet the required liquidity needs so the company could execute the appropriate trials & documentation for FDA submission. Please note that that I mean both logical and realistic.
You know very well that it takes time. He has been on board for one year. He can't solve the world's problems within that timeframe. However, the October FDA meeting will be an excellent start.
I'm just hoping it's not a Cleveland Steamroller.
A warning letter that they are embarking on a journey that is going to shake the pharma indusrtry. Beware of skyrocketing PPS in 2015.
Good thing he's kept his word so far. lol not sure why everyone doesn't have the unfounded faith that you do. Reality strikes yet again.
I recall mid-September being the re-launch target, but I don't recall them specifying any specific year. Perhaps 2018? Might be more of a realistic goal to work out these last major kinks...again.
This was a very unexpected pleasant surprise. Many had hoped for this. Wonderful to see it actually came to fruition. Very well played.
Per R&R release on yahoo finance:
The presentation will be webcast live. To access the webcast, please visit www.elitepharma.com. The webcast replay will remain available for 90 days following the live presentation.
Should be a great conference!
Are you the one that replied the same thing to my finance posting? I'm looking for more than a copy/paste and for an explanation in English. What is the meaning of the lower Cmax? The rest of the PR looks absolutely fabulous, but this criteria is called out. How big of an issue is this? Perhaps NH will clarify at the R&R conf.
If you can't answer, please don't respond. Thank you
Great news overall! Finance is my background, not pharmokinetics. Can anyone further explain the meaning of the lower Cmax for ELI-202? Does this mean it's not exactly bioequivalent? This explains the delay in results from initial expected timeframe, but not certain as to how big of an issue this really is. I know that the Cmax & Cmin are typically used in generic drug bioequiv testing. Anyone have this expertise (and not guessing)? Thanks! (Posted on Yahoo Finance as well).
I think 10-k will be released after hours so commentary can be added without too much trading time between release& conf call.
There are no FDA decisions that need to be made. NDA will be taking place by the end of the year.