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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.
I stand corrected. Thought they followed calendar year for 10-K filing due today similar to most small biotechs.
Floundering on lower volume. I would expect healthy growth in revenue, however, the real news is the progression of partnership conversations, BE trials, R&D initiatives, etc.
10-K is due today being 90 days after year end. I would expect it to be released after hours or first thing tomorrow to be followed up within a few days with a cc. Q1 results are also due within 45 days after quarter ends so we should get another cc and financial release by mid-April.
Please name one penny stock that reports prior to their 45 day period. All organizations use a 3rd party auditor to verify financials and perform their quarterly audit process before financial results are released. The 45-day period is absolutely normal.
There is a tiered requirement for large, mid & small organizations as to when financials need to be released. As the company grows in size their requirement to release is shortnened. If they released earlier shareholders would quickly become accustomed and demand that level of standard going forward. That would be a terrible internal business decision. Why decrease the time to report when there's an increased risk to make an accounting or other financial error. I'd rather have pure data than have them be run the risk of restating earnings down the road.
I'm in agreement. Retail investors are typically whiners that complain after every little dollar lost. Your money typically isn't worth a call to IR so please quite wasting their time. If you're trading on "hunches" then you should be daytrading instead of trying to hold long and can't withstand the ups/downs of the stock and/or market in general.
There's absolutely nothing illegal about the transaction that just took place. It was a simple private equity deal that gives MCLN the adequate financing for working capital. With future cash inflows + the 36 month equity deal (for which further dilution will take place as only a few million dollars worth of shares were purchased yesterday) there should be plenty of cash available to get this company off to a good start.
This is a stock that's primed to have a strong future, but will be slow and steady.
Companies are finding more and more that they cannot rely on banks/loans for financing. Banks are only willing to loan you money when you don't need it (risk averse). In this case they see a better financing opportunity than one previously presented and are forward thinking. They're counting on a challenging future ahead and are collecting cash now versus the risk of not collecting as much or with as favorable rates in the future.
Per Yahoo, 701M shares outstanding w/ 588M in float. Scottrade's O/S is almost identical, but doesn't provide a float figure. Do you have a different figure? I've used Yahoo for years and found the data to almost always be reliable.
Please correct me if I'm wrong, but this is a private equity deal. The only impact this has is further dilution. If I understood the 8-K correctly, MCLN is selling $15M worth at 95% of an agreed upon market established price over the next 3 years.
With close to 600M in float I highly doubt the retail investing group has the clout to hold their shares and force the price to go up. There are always sellers with penny stocks whether or not we're among them.
Please keep in mind that the best analysis in the world cannot predict market movements like we've been experiencing over the past couple of weeks. Some economists might have "hunches", but nothing ever that's concrete. Market movement is hard to predict. Analysis does not equal fortune telling.
Long-term traders base movement on fundamental analysis. This doesn't predict tomorrow's movement, next week's or even quarter, but it does point where the company has been and hopefully going based on recent CEO comments.
You know very well that all stocks got nailed today, not just MCLN. I would expect a bounce tomorrow after today's fall, but just based on a "hunch" and how markets have reacted historically after most big down days.
Somewhat off topic, but does anyone actually subscribe to IHub for their premium services? If so, why?
L2 quotes are free with online brokerages. Never noticed the other services they offered until now.
I'll be holding for quite some time. Won't go back to daytrading until late this year or next due to lack of time to invest each day. Hoping MCLN plays out well. My other long-held stocks use the Finance.Yahoo boards which is usually where I post. Best of luck to you.
I can many can understand your frustration. One tip that might be of benefit for this stock & others that when a CEO provides specific future sales outlook - cut those figures in half to be realistic. They are lofty goals for various reasons.
Their PR of 100% comp. annual growth hasn't come to fruition as of yet, but their deadline hasn't passed either. We don't know what they were thinking, but many traders perceived that the sales would be spread, or mostly spread throughout the year. If 10-Qs for Q2 & Q3 are just as fruitless then we know this was nothing but a smoke & mirrors game.
Best of luck.