Trick or Treat?
Nasferatu awaits...
Monday, October 30, 2017
Thursday, October 26, 2017
Time For ELTP Commentators To Address Problems
Mazeppa  | Thursday, 10/26/17 02:44:34 PM | |
| Re: None | ||
| Post # of 275031 | ||
So, given Nasrat kept the warning letter a secret until his hand was forced, will he keep it a secret if it is rejected again and the same process ensues?
Couch, not to be picky, but frankly I am really confused as to what point are you trying to make with the ongoing banter of having called a 10-bagger like 3-4 years ago...why does that matter now? We are now at .08-.09, so I do not see any reason of such effort worthy an endless argument over such a call, which for the record I believe you did make, but don't see how it is relevant now and the banter unproductive. I think I am missing your point, but would ask you clarify what it is because I have very limited time to go through the posts. I am not "getting" what you are trying to express and certainly wish to do so if it is important with respect to why I should keep holding this. Seems like there are a lot of other companies right now doing quite well and losing on the opportunity cost of holding. TIA.
On a more important issue, as the sp is simply the market cap divided by number of OS, while .088 looks "undervalued" the real question of valuation is whether the company is worth the current market cap or not. Currently, SequestOx is doing nothing, the ANDA's are just sitting around not being assessed, the warning letter is unresolved and just hanging up everything, the SunGen "partnership" has so far resulted in nothing at all (as with Pura), and the company is operating at a small loss, thus likely diluting more. What justifies a market cap of more than 70m? Even at .15, that implies a market cap of 140m or so (not trying to be exact), so why would such valuation be appropriate at this point? Unfortunately as a long, as of now, I see nothing that leads me to believe a .15 sp is justifiable right now. Yes, if some of the "DollarLand" prognostications come through, but so far everything has failed or stalled in limbo.
Can anyone tell me, or post a link, to where Nasrat was called "The Closer" when at Activis, or is it an urban board myth? I thought he was a QC guy...QC guys don't close anything. Nasrat lied by omission about the SOx t-max, and again about the warning letter and its impact. What is with the pedestal people seem to put the guy on?
GLTA as usual--enjoy my days more when I don't check the sp it seems, unfortunately,
Maz
Couch, not to be picky, but frankly I am really confused as to what point are you trying to make with the ongoing banter of having called a 10-bagger like 3-4 years ago...why does that matter now? We are now at .08-.09, so I do not see any reason of such effort worthy an endless argument over such a call, which for the record I believe you did make, but don't see how it is relevant now and the banter unproductive. I think I am missing your point, but would ask you clarify what it is because I have very limited time to go through the posts. I am not "getting" what you are trying to express and certainly wish to do so if it is important with respect to why I should keep holding this. Seems like there are a lot of other companies right now doing quite well and losing on the opportunity cost of holding. TIA.
On a more important issue, as the sp is simply the market cap divided by number of OS, while .088 looks "undervalued" the real question of valuation is whether the company is worth the current market cap or not. Currently, SequestOx is doing nothing, the ANDA's are just sitting around not being assessed, the warning letter is unresolved and just hanging up everything, the SunGen "partnership" has so far resulted in nothing at all (as with Pura), and the company is operating at a small loss, thus likely diluting more. What justifies a market cap of more than 70m? Even at .15, that implies a market cap of 140m or so (not trying to be exact), so why would such valuation be appropriate at this point? Unfortunately as a long, as of now, I see nothing that leads me to believe a .15 sp is justifiable right now. Yes, if some of the "DollarLand" prognostications come through, but so far everything has failed or stalled in limbo.
Can anyone tell me, or post a link, to where Nasrat was called "The Closer" when at Activis, or is it an urban board myth? I thought he was a QC guy...QC guys don't close anything. Nasrat lied by omission about the SOx t-max, and again about the warning letter and its impact. What is with the pedestal people seem to put the guy on?
GLTA as usual--enjoy my days more when I don't check the sp it seems, unfortunately,
Maz
As a point of reference also note they released the JFK files today, so have at conspiracy freaks!
Monday, October 23, 2017
Ihub Post Of The Day
| Couch | Sunday, 10/22/17 07:28:39 AM | |
| Re: stockboy post# 274544 | ||
| Post # of 274587 | ||
10 FACTS of LIGHT leading to DOLLARLAND = $$$$$$$$$
1) It's important to keep in mind, and as Nasrat will discuss, our resources are being increasingly focused on our generic and opioid pipeline, and preparing for the launch of the generic products already filed with the FDA, as well as the generics which are licensed currently to Epic that will be coming back to Elite in late 2018, when that license expires.
our business is moving away from this type of revenue stream that is dependent on third parties.
2) the resources which were previously utilized for contract manufacturing were allocated to product development. Instead of making Methadone batches, these resources were used to run batches in products which are under development. In addition, we extended our lab and regulatory personnel to support this greatly increased product development activities.
The level of product development activity is the highest that I've seen since I've been here. And I've been with Elite since 2009.
3) there are three ANDAs already filed and under active review with the FDA. Also several other products in various stages of development that we expect will result in more ANDA filings over the near and mid-terms.
4) SequestOx - We are right now focusing on evaluating the right path forward for us to resolve this issue. Epic is negotiating and engaged with us. We've received several phone calls from them, offering their help and we made the announcement regarding the fat study.
5) Our ER products and pipeline are moving forward - And we are pursuing ER formulations. As a matter of fact, most of the money is in the ER extended release formulation
6) We started our aggressive program of filing one ANDA per quarter in Q3 of 2016. We filed one then and we filed another one in Q4, and a third in Q1 of 2017. We missed Q2 of 2017. We are scheduled to file one in Q3 of this year, so it's going to happen way before the end of this quarter and we are scheduled to file another one in Q4 by December.
7) The FDA has granted us 12-month extension for resubmission. One of my main concerns was if we missed this date by December of this year, which we will - that we will end our PDUFA fee and then we'll have to pay another one. We communicated with the FDA and they give us a 12-month extension. Now we can file any time in 2018 up to and through December 31, 2018 without asking for another extension if needed. And if the results are valid, we can proceed within that timeframe without paying another PDUFA fee.
8) we have many other valuable products that are progressing rapidly right now. At Elite, when we were manufacturing a little more, the number of [entries that I remember on our study] [ph] was about 13. And now, we're up to 50 and growing. And the reason we're growing even though the manufacturing part is not our primary focus and small, is because of all of these projects that are going to lead us within the next couple of years to becoming a seriously viable company. FYI, the total market size of the pipeline products that we are co-developing with SunGen is $6 billion.
9) All Elite needs is about $50 million in profit for our stock to go to dollar land, do the math. For our future growth, Elite pipeline will be the driver. We want to ensure a high rate of revenue growth by aggressively targeting one ANDA filing each quarter. Okay. As I stated earlier, out of the last four quarters we have submitted three ANDAs. We are scheduled to submit one this quarter and one in the quarter after.
10) we have completed the expansion of our manufacturing facility in preparation for our new product approval and launches.
1) It's important to keep in mind, and as Nasrat will discuss, our resources are being increasingly focused on our generic and opioid pipeline, and preparing for the launch of the generic products already filed with the FDA, as well as the generics which are licensed currently to Epic that will be coming back to Elite in late 2018, when that license expires.
our business is moving away from this type of revenue stream that is dependent on third parties.
2) the resources which were previously utilized for contract manufacturing were allocated to product development. Instead of making Methadone batches, these resources were used to run batches in products which are under development. In addition, we extended our lab and regulatory personnel to support this greatly increased product development activities.
The level of product development activity is the highest that I've seen since I've been here. And I've been with Elite since 2009.
3) there are three ANDAs already filed and under active review with the FDA. Also several other products in various stages of development that we expect will result in more ANDA filings over the near and mid-terms.
4) SequestOx - We are right now focusing on evaluating the right path forward for us to resolve this issue. Epic is negotiating and engaged with us. We've received several phone calls from them, offering their help and we made the announcement regarding the fat study.
5) Our ER products and pipeline are moving forward - And we are pursuing ER formulations. As a matter of fact, most of the money is in the ER extended release formulation
6) We started our aggressive program of filing one ANDA per quarter in Q3 of 2016. We filed one then and we filed another one in Q4, and a third in Q1 of 2017. We missed Q2 of 2017. We are scheduled to file one in Q3 of this year, so it's going to happen way before the end of this quarter and we are scheduled to file another one in Q4 by December.
7) The FDA has granted us 12-month extension for resubmission. One of my main concerns was if we missed this date by December of this year, which we will - that we will end our PDUFA fee and then we'll have to pay another one. We communicated with the FDA and they give us a 12-month extension. Now we can file any time in 2018 up to and through December 31, 2018 without asking for another extension if needed. And if the results are valid, we can proceed within that timeframe without paying another PDUFA fee.
8) we have many other valuable products that are progressing rapidly right now. At Elite, when we were manufacturing a little more, the number of [entries that I remember on our study] [ph] was about 13. And now, we're up to 50 and growing. And the reason we're growing even though the manufacturing part is not our primary focus and small, is because of all of these projects that are going to lead us within the next couple of years to becoming a seriously viable company. FYI, the total market size of the pipeline products that we are co-developing with SunGen is $6 billion.
9) All Elite needs is about $50 million in profit for our stock to go to dollar land, do the math. For our future growth, Elite pipeline will be the driver. We want to ensure a high rate of revenue growth by aggressively targeting one ANDA filing each quarter. Okay. As I stated earlier, out of the last four quarters we have submitted three ANDAs. We are scheduled to submit one this quarter and one in the quarter after.
10) we have completed the expansion of our manufacturing facility in preparation for our new product approval and launches.
Saturday, October 21, 2017
Here's A Theory As To Where Elite Pharmaceuticals Inc (OTCMKTS:ELTP) Is Going With Generic OxyContin
Elite Pharmaceuticals Inc (OTCMKTS:ELTP) just announced its submission of an abbreviated new drug application (ANDA) for a generic version of extended-release oxycodone hydrochloride.
Some reading may already be familiar with this drug by way of its commercial name, OxyContin. Others may also be familiar with the difficulty that a number of other companies, most notably Epic Pharma, which was acquired by PuraCap back in March last year for around $550 million, had with their respective attempts to do what Elite is trying to do right now.
Friday, October 20, 2017
Charting Sinking ELTP
2-year ELTP chart
Predictions by some of the bashers on iHub have been eerily coming to fruition as the Elite Pharma team silently works out various concerns.
However, the company has been profitable and if some of the issues get worked out there could be a nice rebound. Investors wait for the time, but at .092/share, there is reason for concern.
ELTP really needs some positive FDA news, but every day seems more and more difficult to trust.
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