Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Well said! It seems that there are many who have not done any DD, not at the least bit review the last CC, which clarifies quite a few things. Nasrat is not leaving much in terms of surprises. He has told shareholders in no uncertain terms what he is doing, what his priorities are, and where he is leading this company to.
The meaningful announcement that the market wants to hear is 1) continued positive trials results, 2) approval of products, and 3) the terms of the partnership, if it comes to fruition. Those will be the drivers of the reversal in PPS. Gaps, naked shorts, etc, are all just to rationalize why the PPS has dropped. N2koolaid, do you have other views?
But the one weak hand still hasn't been shaken out ;)
we need to help him with that....
Old timer, why are you so fixated on the .97? The psychology guiding you is very difficult to follow.................
Old timer, I'm looking at the same information and sources that you are. I then apply my experiences, knowledge of this space, and a little bit of common sense, to shape my investment decisions. Hope this helps.
3454, I have to thank you since you have shown me the "light". Every "point" you bring up has pushed me to do more DD than I had done in the past. I am more convinced than ever of my investment in this company and its potential. Believe me, this is coming from someone who has been working in pharma for many years.
I encourage others to do the same. You will quickly separate the facts from the fictituous points being raised by those with transparent agendas and little substance or evidence to support the FUD.....
Richme, such is the life in a biotech in its infancy...it's all about R&D and spending on clinical trials to get that roi down the road....not sure how your years of experience have not taught you that ;)
Richie, did this bit of news surprise you? Did you call-in to the CC or listen to the recording afterward?
Couch, I just viewed your PM from Friday. I don't have PM here, but you can email the "riddle" at rgdphd@yahoo.com
we can exchange some additional info regarding this space.....
Lasers, i believe elite will go at it alone if and only if nasrat does not get a good partnership deal. But I truly don't believe that will be the case. The results are outstanding, the market potential is huge, and the opportunity for partnership that was laid on the table by Nasrat - taken all together, BP would be foolish passing it on. Nasrat wants to get these products on the market as quickly as possible, and he knows that a partnership will bring this "speed" of execution.
Jason, refer to dr bmt's last post....it is clearly laid out. This does not necessarily mean elite is going at it alone. Review the CC transcripts. They tell you what needed to be done to get the infusion of cash in. Most of the DD longs here agree that the partnership will happen once the abuse liability studies are completed soon.
Removing this hurdle will alleviate a technical issue that may have impeded a deal....
That does not mean (a) nor (b), as you state. If your agenda is investing in the company for the long term, I suggest you review the transcripts of the CC. It is very clear what management was going to do. If your agenda is FUD, I suggest putting a little more creativity.....
This was expected, and should not surprise anyone. Even though this is a positive development, some will probably just look at the headline and not read the details.....MMs will pounce on that ;)
Exactly!
At the recent CC, both Nasrat and carter did speak to the need to address the AS issue ("at a later point") on e those preferred shares were issued. I do believe removing this hurdle paves the way for a partnership deal by the summer.
You can trust that elite and their CRO know what sample size is needed. This is not a guessing game as to what works for the FDA.
Richme, I think you know how the game works with MMs too...for the most part, they want to have zero balance shares at the end of the day (unless they are accumulating in their personal accounts - which is a different story). Thus, on a day like today, they will sell shares on the run-up, creating a negative balance, and the. Walk it down and cover those shares at much lower prices. Instant profit. It doesn't happen like this everyday. We can't attribute everyday fizzle in daily price to flippers only....
Note that the fda asked egalet to conduct efficacy studies for their egalet-002 oxy product..
Couch, you asked a question earlier about licensing. At this point, if I were part of a team doing the DD on elite's products, I would not want to license anything until I see the results of the abuse liability studies. Or if I do, it will be using language and terms that would de-risk my position, something I am sure Nasrat would not agree to. I would be willing to wait until the results are out, and maybe face the possibility of having to shell out more money, but I would have limited the risk and increased the upside potential. Believe me, there have been many times where we paid more after waiting for additional study results.
The other hand of this is that Nasrat could be there one who will not sign a deal until the abuse studies are completed. He may have total confidence that they will be positive that he will wait the couple of months and then sign a more favorable deal. That is why I am leaning to a partnership announcement sometime in late spring or early summer.
One of the major questions is when elite will apply for fast track. They could be in the process of submitting the application, now that they have the full results from the pivotal be study. Or they could hold off until the abuse liability studies are done. I am not sure when egalet did it, but I would speculate that they will be close to submitting for fast track, maybe in the next month or so.
There is no doubt in my mind that fast track will be given, and that a priority review will be done, which should still put Eli-200's approval date in April or so of next year....
Couch, Lasers, or other DD longs, do you know of any other products that will compete with the elite 24 hr product once approved and launched? I have been digging into the competition for elite's products and wasn't having much luck finding any 24hr ADT asset at any developmental stage.
By the way, after some conversations with regulatory, I do expect the fast track application of Eli 200 to be filed by oct. My concern that the requirement of "life threatening" condition may not be met with Eli 200 was addressed. Apart from the possible partnership catalyst, I believe that this will have a significant impacts on the PPS.
Until the alternative is on the market (e.g. ELI 200/201), and unless the political/regulatory environment act decisively, they will continue to push marketing of this label update.
But you are preaching to the choir about the superior technology of Elite :)
I know lol.....point is they are aggressively marketing this "difference". Interesting, in light of the political and regulatory environments.
Lasers, Send me a note and I will forward the update...they didn't do anything different except highlight the label update....rgdphd@yahoo.com
Don't know if some of you subscribe to healthcare digital media, but I have been receiving many emails from different outlets (e.g. American journal of managed care) with direct advertising from Purdue Pharma on the OxyContin label update. Too long to post here, but I can forward upon request. They tout the abuse deterrence studies.....
Correction..."slur" should say "value" of the technology...autocorrect
To further that, Nasrat has backed up everything he said with action and results so far. When he references a possible partnership, it is not a focus on playing up the share price, but rather a focus in the. Slur of the technology (from the trials perspective as well as the patents). Without a doubt, having a higher share price would give elite better leverage, but believe me, deals can be structured in such a way that share price is not a factor in the equation. Note that elite has already telegraphed that the preferred shares are being reserved for possible partnerships.
After looking at where elite waste last year when this valuation was done, there's no doubt in my mind that the patents on the ART products was a key driver in reaching that 2.10 mark. I don't believe the revenue increase, even forward looking (12 months) was a major driver.
First the patents, now the trial results.....think big picture and visualize the potential that another company would see in what elite is bringing to the table. Think about what Lincoln Capital saw in the first place....you will see that the strategic roadmap laid out makes much investing sense ;)
Of course, I respect your assumptions :)
Th wild card as you imply is the FDA and the political environment. i still believe we will have a hockey-stick uptake when the products are launched sequentially.
Rollin2nyte articulated that possible reason very well and very clearly. Sorry you missed it. I suggest re-reading his post a few times.
Lasers, while I agree with your projections, could you clarify the timeframe you are assuming in your numbers? Typically it will take a few years to reach peak market penetration, even assuming a hockey stick uptake in scripts. I do believe the revenue you present is achievable in the 2017 timeframe, but I may have misunderstood your calculations.
Spot on...some here are so fixated on the identifying the name of the firm (whatever their agenda is), that they are not seeing the forest at all. This is part of larger factors at play here that should unravel in the next few months. The successful clinical trials with the technology are the ace in nasrat's hand right now. The valuation. Is additional leverage to gain favorability in the terms of any deal.
Glad you are on to provide additional solid DD :)
The valuation process is standard in the industry. It covers things like size of the market, the product profiles, the competitive landscape, pricing, order of entry, growth rate (of the company and of the market), and other factors. It is not a secret how valuations are done. Elite's firm would have followed the standard process.
The name of the firm is irrelevant at this point in time. That is spreading FUD at its finest. Elite is not obligated to release the name of the firm, as it is not material to what investors need in their DD. The fact that trials are ongoing and planned, that some trials have already reported out, that there is a place in therapy for these products once approved and launched, should provide investors a way to measure true value of this company and an opportunity to increase their confidence.
Let's educate on the REAL things........
Invest based on the name of the valuation firm...now that's original...I'm investing because I happen to like the word "elite" ;)
Not sure why the focus is on name of the firm, when investor confidence should be driven primarily by the outcome of the trials. The greater success of those trials, the more investors should be confident. In all the DD I get involved in as part of our L&A activities, I have never seen anyone focus on getting the name of a firm who did pricing research or otherwise. It has been on the study designs, their outcomes, the investigators involved, the comparators, etc.
Investor confidence should be focused on last week's PR highlighting the successful trial outcomes.
Appreciate that, pgp. I truly believe this is a classic case of underpromising and overdelivering. I'm actually very excited about the possibility of a 1H 2015 launch of the first product. That would be a major coup.
I suspect that Nasrat will apply for fast track and that eltp will get it for Eli-200. My personal belief is that the product is approved no later than April of next year.
Checked with regulatory colleagues about the fasttrack designation...the request should be made by the company and the FDA has 60 days to respond.
Some qualifications:
- A rationale for why this disease condition is serious and life threatening
-Represents a signficant unmet medical need (despite current care)
I welcome the board to comment on the "life threatening" piece of this. Can this disease condition be considered life-threatening due to the potential for addiction and overdosing?
Of course, one can expect that Nasrat and co. will not comment on their strategic options for filing, but I still suspect filing to happen before the end of Oct, with a target of Aug 2015 for approval, at the LATEST......if granted fasttrack, approval would be in April 2015.
while i like your SWOT reference as a determinant for when we get to $1, there are major factors in play here that will get us to $1.....mainly the specifics of a partnership deal.....
Rob,
Excellent points....but I do want to underscore point #2
2) support ELTP management's plans
It is critical for all of us who have done and continue to do DD here to educate on these plans, but also to ask questions of management and periodically challenge their assumptions. We can only help make this roadmap better. I found the questions asked during the last CC to be extremely well-thought out and succint; I give Nasrat and co. alot of credit in that they answered the questions with alot of clarity. They could have been vague, but weren't. That to me is another sign that the management team is fully engaged in the dialogue on the plans.
As long as you can keep emotion out of it, and stay the course (which you have been, I may add), you will be rewarded big time ;)
Unfortunately, uplisting does not necessarily mean the end to manipulation, but there will be less of it. Nasrat has laid the roadmap. It is the obligation of the DDers here, in my opinion, to educate others on this roadmap, and the likely eventual outcome of the long-term plan to get as many of these products on the market, as quickly as possible.
A special thank you to the DD longs, who provided me with much insight and shortened my learning curve prior to entry into the stock several months back.
Lasers and other DD longs, I am checking with my regulatory colleagues on the fast track issue in this area. I want to see what the company's role could be in steering the submission towards that. Given nasrat's mandate to get products on the market as quickly as possible, it is possible that the first filing could happen in in the sept/oct timeframe. Fast track status would be determined shortly thereafter.
Did you buy to flip, or did you buy for the prospects associated with the company? If the former, then yes, I agree with you that you have lousy timing. If it is the latter, then you will be fine. You need to grow some "nerves of steel" ;)