Holy self limiting answer Batman....As many as have the Yahoo handle "gordonhoochie"...one...
But, like your statement "will work with any opioid product" it's self defined...not a single ART product has been accepted as "works" by anyone who wasn't ELTP or in their pay. An independent 3rd party validation that could include an independent outside agency or partner who's willing to put some of their own skin in the game is sorely needed now to keep the stock price momentum going moving upward.
The empty rhetoric and cheerleading of your post isn't going to do it.
Do you really believe that posts to a bulletin board site really effects the stock price?
Remember..if they drop to $0.15 Lincoln bank owns them..so they need to make money on they're generics and not use the line of credit to finance it..that's money should be earmarked for R&D/clinicals and regulatory filings.
They turned the corner on generic profitability recently, so slipping back into it being cash negative would be very troublesome to us stockholders(but not the Lincoln Bank)
I have one question and two comments.
In the last quarter did the generics operation make or loose money? From the CC it wasn't clear to me at all.
Comment 1..As I said before, efficacy is not the issue here..it's not a concern about the survival rate being 2% better. The question is can the actives be removed from the tablet and purified or not. If ARC is even 20% more difficult (ie. better), no the game isn't over as it was with Taxotere..ELTP will not dominate the market. In this situation the race goes to the swiftest, not the better. which is not to say ELTP will be shut out..2nd suppliers are always welcome, but the sell will be harder. However, they don't need to sell much to support a price of $1.
Comment 2-I'm much more concern about CEO being much more selective about the info he emphasizes in the CC. Seems in the past he was more up front about both the good and the bad. I thought he was a cut above the other talking heads in this industry, but maybe I was wrong.
While my long term sentiment remains buy, my short term is hold(yes I do own shares..I have since they were at $0.08). I think t may drop to 0.25..the 4 year support point before moving up again..in which case I may buy more.
Deeptinker..this isn't bashing..it's independent thought being conveyed into an open forum..
Goochie..you not going to like what I have to say, but here goes..
All this great news about the ongoing businesses and access to cash raised to stock price for 6 cents to 25 cent..as they aren't going to go out of business in the near future. Revenues are one thing..profits are another..I didn't hear anything about all this revenues costing less than the revenues they brought in. Maybe because there were startup costs because there were so many new products,,but CEO needs to be front and center about these things as I've seen him in previous CC's. The tone of this CC was different, in my opinion. The facts were given out selectively and it was up to us, those who do real DD and not just chearleading to sort them out. It's this change in tone that really really worries me.
Another thing that worries me Purdue getting priority review. I didn't see that mentioned in this board, or maybe I just missed it. Or maybe only positive DD gets highlighted and competitive analysis is unheard of.
Here's why the Purdue priority review concerns me:
For those of you who have seen a product go for marketing application here's how it works:
The FDA wants to have solutions to unmet needs. When they are not met it's easier for a solution to get an approval. When a solution is found the bar is raised for newer solutions.
If a newer solution is found, if it is more efficacious, then it will replace the older solution. If it's just a more reliable technology, then there's no rush to get it out there.
You can argue all you want that ELTP's ACT is better, but that's not the point. If Purdue's system is good enough, it will be the industry standard as efficacy is not the issue here.
Purdue's success raise the bar for what ELTP has to show the FDA, and make inroads into marketplace.
The window is closing and ELTP better hurry up and get there.
This is the reason, I think for the drop in stock price..it itsn't that people are stupid, it's that the risk/reward perception is in transition
Good point, but technically he wasn't talking about that..he said it was on the books for $3.5MM and they received $5mm...not whether they made a profit or not..they recovered more than they thought they week. That isn't important..what is important is cash on hand and whether the current operation is profitable from a cost of goods sold point of view. I didn't hear anything about that..It's great to increase your sales, but you need to make a profit on each unit sold. Does anyone know if they made a profit on their manufacturing operations?
In previous CC's he seemed more contrite, cautious and controlled. This CC he seemed much more of cheerleader with all cautionary statements thrown out. This worries me because he's talking about events 6 to 9 months in the future as done deals that he in reality has very little control over (namely the FDA). Previously his tone had been cautious optimism.
Michom..your applied assumption is that ELTP has a 0% chance of seeing any of the issues that their competitors have seen from the FDA. Why do you think that's realistic? The FDA doesn't have absolute standards. It slides depending on how severe the problem is. My assessment is that due to the DEA cracking down on the MD prescriptions, the FDA views abuse as a less severe problem then it did a couple of years ago. The bar keeps getting raised even as we speak.
As for first question..to reach their goal of $2.5/share, they'll have to capture about 15-30%of the market from their present 0%. They need a marketing partner to do that. Starting a sales force from scratch is ill advised. They're biding their time in getting a partner. If the risk is lower, due to good clinical/test data, the cost of the partner as a % goes down. You may not see that announcement until after the NDA is filed.
What happens once the NDA gets approved? Then you need to sell the product. Until about 18 months ago, the stock value in this field was just before the NDA approval. After that you need to get real and often the scripts sold trailed the projections..just ask Vertex or Human Genome about that..
In this market, nobody seems to a care..
Timmy just chill..take sedative or something...this is the pharma business and these sorts of things happen all the time..be patient..they're not running out of cash or anything like they were 6 month ago..and they can fund these trials now..they couldn't just 2 months ago..
Maybe they're rethinking some phases of their trials based on the response ACURA got from the FDA..much better not make mistakes than rush in with a faulty NDA ACURA style and need to start over.
And if this were the case, why would Dianne tell you? Kind of confidential, don't you think?
Timmy darling, have every invested in this sector before?
I agree with you beegle..this board is more and more a waste of my time as it's degenerated into personal snipes worthy of 8th graders
Please list them..you'll see that alot are from eternal startups that are trying to push some funding their way. This happens every time a field gets "hot". In the end the DEA may shrink the the market down to a size where extracting active isn't a big issue any more. In the meantime ELTP may get a foothold as their program is real.
From what I can see there are only 3 or 4 real competing programs.
And who are you Investorgirl22? At least I use my real name..
Who cares....does their arguments make sense based on your education and experience? Do they give you information you didn't know and can verify independently? Do they cause you to think of things you wouldn't have considered otherwise? Then use it.
Many poster are just saying, Hurrah for my side..and they have a computer and internet connection..
Nope...only catalyst may be a partnership, but that's a long shot in the time frame your talking about.
The road market approval is long and well known. Not much there for instant gratification which most subscribers to this board seem to demand.
What universe do you live in? The pps is up 500% year to year..that isn't good enough for you? Nasrat said the valuation was put at about $2.5/share AFTER all the work was done. Nasrat also said that the work has barely begun. He seems to have a grasp of reality..obviously you don't. His vision extends out years..yours..maybe 3 months at most?
Personally I'm pretty happy where they are...
Camargo gets paid by ELTP for the work they do, whether or not it's approved thy get their money. That's what they do for a living. They are a hired gun.
Like it nor Gordie not everyone in the world shares your enthusiasm. That's why the price hasn't jumped(that and biotechs getting beaten up in general).
All these we are great arguments...Camargo is taking their money, CEO takes stock, not salary, this guy or that has put his own millions into it..that's why the stock isn't at 6 cents any more..(how soon we forget)
The next major boost will be from an outside affirmation. Either FDA or a partnership.
If this is too risky for you Tim, then invest elsewhere..otherwise
Chill and be patient.
The reality is that it's going to happen when it happens..you need to look at the CC's carefully and integrate into what you know about the approval cycle. They're alot of "red herring" wording in the CC's..ie. the future is not certain so invest at your own risks
Realistically I don't see any approvals until Q2 2015 at the earliest. However, they are well situated now cashwise to make this happen...even if nothing is approved until 2016.
If the market doesn't understand this and drives the price down, that's great for me. A good purchasing point will appear. I'm fine with this stock as long as it stays above 0.25..if it drops below that, it's a sign of a fundamental change for the worst has taken place.
I think your pessimism is based on your lack of understanding of the pharma development cycle. Have you ever invested(or traded) in this sector before?
ELTP has done a very good job on the business end by 1) becoming cash neutral with ongoing operations and 2) securing financing for clinicals ,other testing and permitting. 2 was done at cost lower than most companies in the same position.
Their pace moving forward will have more to do with their interactions with the FDA then anything they can do internally. The FDA will not be a continuous open door whenever ELTP feels like dropping in fort a chat. Meetings need to be scheduled..explicit and implicit agreements reached. Applications filed for clinicals where mandated review periods are required. Etc Etc
One of the main reasons I'm positive about ELTP is that their CEO comes from QA/Regulatory. This is highly unusual in this industry(believe it or not), but I believe his understanding of the complexities involved in dealing with the regulatory agencies will be the most important factor in the rollout of their products.
If these realities upset you (and apparently they do), may I suggest that you invest your money in a less regulated area such as ROCK.
As I stated in a previous post, the bank has their bet hedged. If Naz is successful then they're shares are worth more than thy paid for them. If he isn't then the share stock will drop and depending on timing they may own the company, as they could get more then 50% of the shares.
If you noticed they didn't float a $50MM bond at 2% like Apple could.
They're risk is much less than yours or mine.
I'm quite positive about them. I think they are going after a good target and are executing it nicely. I think the CEO is much more realists about this in his CC's than I've been seeing among the bulls here.