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.
No comments:
Post a Comment