ELTP Recent activities 08/25/2014 09:32:37 $ELTP
The timing matters because of the competition and the fact that time is money and you don't want to exhaust your resources because of delay. In that regard Mr. Hakim has set a timetable and is pushing to meet self imposed deadlines
My thoughts exactly lasers. Last year all Nasrat had was that we were gearing up to start our first pilot study. This year Nasrat will be able to share multiple trial results with those in the audience and tell them we are on track to file our first of many NDA's this December.
I'm looking for a very positive reaction, much like last year. If I'm not mistaken, we saw a nice percentage pop from last year's conference.
ELTP Stock Message Board http://investorshangout.com/Elite-Pharmaceuti...LTP-61177/
R&R Conference is in two weeks. I see Elite on the schedule at 2:55 on Sept 9.
www.rodm.com
In Move to Curb Drug Abuse, D.E.A. Tightens Rule on Widely Prescribed Painkiller
By SABRINA TAVERNISE
AUG. 21, 2014
New York Times
WASHINGTON — The federal government tightened the prescribing for the most common form of painkiller in the country on Thursday, the final step in a policy shift that has been years in the making.
The stricter rule for hydrocodone, which is the most widely prescribed painkiller in the United States and which is an ingredient in drugs like Vicodin, is one of the most far-reaching efforts to stop the growing epidemic of prescription drug abuse. More than 20,000 Americans die every year because of prescription drug abuse, according to federal data.
The rule places hydrocodone in a tougher, more restrictive category, and the changes it requires are sweeping. Doctors will no longer be able to call in prescriptions by telephone, and patients will not be allowed to get refills on the same prescription, but will have to return to a health care professional to get a new one. The drug will have to be kept in special vaults in pharmacies. The Drug Enforcement Administration published the rule on Thursday; it will take effect in 45 days.
“This is substantial,” said Dr. Nathaniel Katz, assistant professor of anesthesia at Tufts University School of Medicine in Boston. “It’s a sign of a shift toward more cautious opioid prescribing.”
He added: “This will be an inconvenience to some, but policy is a machete, not a scalpel, and you have to figure out where to use it. I think people will be more helped than harmed.”
Abuse of painkillers now claims the lives of more Americans than heroin and cocaine combined, according to federal data, and the number of Americans who die from prescription drug overdoses has more than tripled since the late 1990s. Prescription drugs account for the majority of all drug overdose deaths in the United States. In all, drug-induced deaths have outstripped those from traffic accidents.
Senator Joe Manchin III, Democrat of West Virginia, whose state is among those hardest hit by the epidemic of painkiller abuse, applauded the change. He called the shift “a tremendous step forward in fighting the prescription drug abuse epidemic,” one that he said would “undoubtedly help prevent these drugs from getting into the wrong hands and devastating families and communities.”
Still, the change is sure to draw strong criticism from some pain management experts, who argue that the rule creates unfair obstacles for patients in chronic pain, making it harder, for example, on those who cannot easily make a trip to the doctor.
Other experts point out that the change will not necessarily lead to less abuse. For example, oxycodone, another highly abused painkiller and the main ingredient in OxyContin, has been in the more restrictive category since it first came on the market. Oxycodone and methadone account for far more overdose deaths than hydrocodone.
Dr. John Mendelson, a professor of medicine at the University of California, San Francisco, and an addiction specialist, said he expected the change would lead to an increase in prescriptions of other drugs such as oxycodone, and a rise in the use of heroin, which has been increasing as towns and cities crack down on prescription drug abuse. He said he believed the small decrease in addiction to prescription drugs that the changes could bring would probably be offset by an increase in heroin use.
$ELTP having completed successfully all ELI-200 and ELI-202 BE/PK trials, meeting with FDA Sept/Oct 2014 and filing NDAs by Dec 2014, makes R&R 2014 big difference vs R&R 2013!
So if one bought at 1,000,000 ELTP shares at 0.04 and sold them at an average of 0.85 and later bought 2,833,333 ELTP shares at an average of 0.30 that one would have made a bad gamble?
I agree lasers. IMO, the Rodman conference could be a game changer for ELTP this year. I fully expect institutional ownership to increase after this conference.
NOPE! This is a long term investment. Buy and hold for the buyout in a few years in order to get the MAX PPS. Selling before then equals I don't like to make the most money possible.
I agree 100%; great post.
Good morning all. My one allowed post so I will ask a simple question. Why does anyone care how long this takes? If you did your research, checked your financial stability, and bought accordingly, time would not be an issue. I personally have never hyped ELTP, as I think it foolish to buy something based on some nameless, faceless posting on a message board. Every post is pure speculation. The ELTP board helps keep some of the facts in front of the public but in the long run it's always about which group is the more superior. There are several here who post the technical links needed to do proper research but I have seen them back away from posting and one can hardly blame them. If we could all remember to ALWAYS take profit along the way and most importantly, decide how much you want to risk on the downside, life would just be easier. All of us have made the mistake of riding the ride up and riding back down. If it is a play you are convinced in your heart of hearts is a good play, you ride it out. I've pulled more bonehead moves in the OTC than most, which is why no matter my belief, I take profit if it becomes available. So stripping away all of the noise, if one believes the science is sound and the eventual demand is in fact warranted, why does it matter how long it takes ELTP to succeed ??? I will get PMs from some, telling me how stupid I am,knowing I can't answer back, and that's fine. I would just like the timing question about ELTP answered. Have a great week everyone
Quote:
Nasrat has a veteran's cleverness and not a newbie's impetuousness.
But he doesn’t understand that bloating the float decreases the PPS. LOL
mightymike, skydog526, $ELTP now in the process of filing NDAs for ELI-200 and ELI-202 and soon ELI-201. Those who ignore or remain in the dark are at serious risk!
Yes indeed R&R 2014 vs R&R 2013 is a BIG difference for $ELTP!
"Unidentified Analyst" lol lol
I think all pharma companys already know this, there are no secrets in the pharma world, most probably already contact
ed elite already at one point
IMO, most importantly, the Major Pharmas with opioid products will be at R&R 2014 checking out $ELTP. These major Pharmas will want to know how close $ELTP is to launcing their ELI family of ART/ADTs. It will be a surprise eye opener for some and a shocker for others. They will know that $ELTP has complete control and now it is up to the FDA as to when $ELTP ELI-200, their 1st ART/ADT, gets approved and launched.
Sounds good. I think there will be a lot more people at the R & R Conference this year. I think last year Couch said there was around 30. I expect 60 or more this time around. Then again, not sure how big the room is and how many people it can hold.
Nasrat has a veteran's cleverness and not a newbie's impetuousness. He know's when to play the cards and not fold. He is going for the big ante where winner $ELTP takes all. He has been at the helm of the major pharmas with vast hands on experience and $ELTP shareholders need to trust his judgement.
No way he is screwing up. A year from now in Aug 2015 will be night and day difference for $ELTP PPS.
$ELTP reaches the Global Pharmas at Rodmand and Renshaw Sept 8 to 10 2014 NY and $Elite makes its latest and newest public presentation since a year ago.
http://www.rodm.com/
Quote:
Presenting Companies
Elite Pharmaceuticals, Inc. (OTCQB: ELTP) (Website)
AS for Generics launching if you are referring to Isradipine
Doug Plassche has done a marvellous job in securing the API for Isradipine. It has been a very difficult process and the supplier of Isradipine wanted to be assured that $ELTP would take the entire batch for Isradipine starting API. The only other seller of Isradipine is Actavis/Watson. Doug Plassche is a leading expert on Isradipine from his employment at Actavis. $ELTP is very blessed to have such a talented VP of Operations Doug Plassche.
Quote:
Doug Plassche
Okay. Actually it’s the [alarm] (ph). So let me walk you through it. I do believe I’ve covered this before. I apologize if you weren’t on the call or I did not emphasize them up. We made Isradipine at our facility in here at Northvale. We put it on stability. We created the CBE-30 and we filed it to the FDA. We had a strict feedback from center that they want us to – they said the CBE-30 is still open. We would like you to validate the process before you launch it. And they literally said to us, you can validate the process and launch and then notify us. So from their standpoint we can move forward.
The issues we encountered is the same issues that a lot public companies encounter. First, the API manufacturer was the only AP. We had single source API manufacturer in our application. So, in order for them to sell us product for us to go ahead and validate they requested first that we pay the PDUFA fee on their behalf. They were not using their DMF. So they wanted us to pay that. We paid it. It was like $36,000 or so.
Then they demanded that we buy all of the raw materials that go into making Isradipine. So we have to fork another chat for $125,000 and then we had to buy the entire lot from them, which we did and the entire lot was API which is lot of API and a lot of negotiations took place between Doug Plassche and these people in order to finally to get us the API. Now that we have the API Doug needs a prioritize it and I anticipate that we will go ahead and finish that edition and launch in Q4 of this year.
Great. That will make me more money. Nasrat knows best and we just have to let him do his job. Everyone just relax and get rich.
That's what the CEO said and I believe him. Anything else is just noise without links.
The timing matters because of the competition and the fact that time is money and you don't want to exhaust your resources because of delay. In that regard Mr. Hakim has set a timetable and is pushing to meet self imposed deadlines
My thoughts exactly lasers. Last year all Nasrat had was that we were gearing up to start our first pilot study. This year Nasrat will be able to share multiple trial results with those in the audience and tell them we are on track to file our first of many NDA's this December.
I'm looking for a very positive reaction, much like last year. If I'm not mistaken, we saw a nice percentage pop from last year's conference.
ELTP Stock Message Board http://investorshangout.com/Elite-Pharmaceuti...LTP-61177/
R&R Conference is in two weeks. I see Elite on the schedule at 2:55 on Sept 9.
www.rodm.com
In Move to Curb Drug Abuse, D.E.A. Tightens Rule on Widely Prescribed Painkiller
By SABRINA TAVERNISE
AUG. 21, 2014
New York Times
WASHINGTON — The federal government tightened the prescribing for the most common form of painkiller in the country on Thursday, the final step in a policy shift that has been years in the making.
The stricter rule for hydrocodone, which is the most widely prescribed painkiller in the United States and which is an ingredient in drugs like Vicodin, is one of the most far-reaching efforts to stop the growing epidemic of prescription drug abuse. More than 20,000 Americans die every year because of prescription drug abuse, according to federal data.
The rule places hydrocodone in a tougher, more restrictive category, and the changes it requires are sweeping. Doctors will no longer be able to call in prescriptions by telephone, and patients will not be allowed to get refills on the same prescription, but will have to return to a health care professional to get a new one. The drug will have to be kept in special vaults in pharmacies. The Drug Enforcement Administration published the rule on Thursday; it will take effect in 45 days.
“This is substantial,” said Dr. Nathaniel Katz, assistant professor of anesthesia at Tufts University School of Medicine in Boston. “It’s a sign of a shift toward more cautious opioid prescribing.”
He added: “This will be an inconvenience to some, but policy is a machete, not a scalpel, and you have to figure out where to use it. I think people will be more helped than harmed.”
Abuse of painkillers now claims the lives of more Americans than heroin and cocaine combined, according to federal data, and the number of Americans who die from prescription drug overdoses has more than tripled since the late 1990s. Prescription drugs account for the majority of all drug overdose deaths in the United States. In all, drug-induced deaths have outstripped those from traffic accidents.
Senator Joe Manchin III, Democrat of West Virginia, whose state is among those hardest hit by the epidemic of painkiller abuse, applauded the change. He called the shift “a tremendous step forward in fighting the prescription drug abuse epidemic,” one that he said would “undoubtedly help prevent these drugs from getting into the wrong hands and devastating families and communities.”
Still, the change is sure to draw strong criticism from some pain management experts, who argue that the rule creates unfair obstacles for patients in chronic pain, making it harder, for example, on those who cannot easily make a trip to the doctor.
Other experts point out that the change will not necessarily lead to less abuse. For example, oxycodone, another highly abused painkiller and the main ingredient in OxyContin, has been in the more restrictive category since it first came on the market. Oxycodone and methadone account for far more overdose deaths than hydrocodone.
Dr. John Mendelson, a professor of medicine at the University of California, San Francisco, and an addiction specialist, said he expected the change would lead to an increase in prescriptions of other drugs such as oxycodone, and a rise in the use of heroin, which has been increasing as towns and cities crack down on prescription drug abuse. He said he believed the small decrease in addiction to prescription drugs that the changes could bring would probably be offset by an increase in heroin use.
$ELTP having completed successfully all ELI-200 and ELI-202 BE/PK trials, meeting with FDA Sept/Oct 2014 and filing NDAs by Dec 2014, makes R&R 2014 big difference vs R&R 2013!
So if one bought at 1,000,000 ELTP shares at 0.04 and sold them at an average of 0.85 and later bought 2,833,333 ELTP shares at an average of 0.30 that one would have made a bad gamble?
I agree lasers. IMO, the Rodman conference could be a game changer for ELTP this year. I fully expect institutional ownership to increase after this conference.
NOPE! This is a long term investment. Buy and hold for the buyout in a few years in order to get the MAX PPS. Selling before then equals I don't like to make the most money possible.
I agree 100%; great post.
Good morning all. My one allowed post so I will ask a simple question. Why does anyone care how long this takes? If you did your research, checked your financial stability, and bought accordingly, time would not be an issue. I personally have never hyped ELTP, as I think it foolish to buy something based on some nameless, faceless posting on a message board. Every post is pure speculation. The ELTP board helps keep some of the facts in front of the public but in the long run it's always about which group is the more superior. There are several here who post the technical links needed to do proper research but I have seen them back away from posting and one can hardly blame them. If we could all remember to ALWAYS take profit along the way and most importantly, decide how much you want to risk on the downside, life would just be easier. All of us have made the mistake of riding the ride up and riding back down. If it is a play you are convinced in your heart of hearts is a good play, you ride it out. I've pulled more bonehead moves in the OTC than most, which is why no matter my belief, I take profit if it becomes available. So stripping away all of the noise, if one believes the science is sound and the eventual demand is in fact warranted, why does it matter how long it takes ELTP to succeed ??? I will get PMs from some, telling me how stupid I am,knowing I can't answer back, and that's fine. I would just like the timing question about ELTP answered. Have a great week everyone
Quote:
Nasrat has a veteran's cleverness and not a newbie's impetuousness.
But he doesn’t understand that bloating the float decreases the PPS. LOL
mightymike, skydog526, $ELTP now in the process of filing NDAs for ELI-200 and ELI-202 and soon ELI-201. Those who ignore or remain in the dark are at serious risk!
Yes indeed R&R 2014 vs R&R 2013 is a BIG difference for $ELTP!
"Unidentified Analyst" lol lol
I think all pharma companys already know this, there are no secrets in the pharma world, most probably already contact
ed elite already at one point
IMO, most importantly, the Major Pharmas with opioid products will be at R&R 2014 checking out $ELTP. These major Pharmas will want to know how close $ELTP is to launcing their ELI family of ART/ADTs. It will be a surprise eye opener for some and a shocker for others. They will know that $ELTP has complete control and now it is up to the FDA as to when $ELTP ELI-200, their 1st ART/ADT, gets approved and launched.
Sounds good. I think there will be a lot more people at the R & R Conference this year. I think last year Couch said there was around 30. I expect 60 or more this time around. Then again, not sure how big the room is and how many people it can hold.
Nasrat has a veteran's cleverness and not a newbie's impetuousness. He know's when to play the cards and not fold. He is going for the big ante where winner $ELTP takes all. He has been at the helm of the major pharmas with vast hands on experience and $ELTP shareholders need to trust his judgement.
No way he is screwing up. A year from now in Aug 2015 will be night and day difference for $ELTP PPS.
$ELTP reaches the Global Pharmas at Rodmand and Renshaw Sept 8 to 10 2014 NY and $Elite makes its latest and newest public presentation since a year ago.
http://www.rodm.com/
Quote:
Presenting Companies
Elite Pharmaceuticals, Inc. (OTCQB: ELTP) (Website)
AS for Generics launching if you are referring to Isradipine
Doug Plassche has done a marvellous job in securing the API for Isradipine. It has been a very difficult process and the supplier of Isradipine wanted to be assured that $ELTP would take the entire batch for Isradipine starting API. The only other seller of Isradipine is Actavis/Watson. Doug Plassche is a leading expert on Isradipine from his employment at Actavis. $ELTP is very blessed to have such a talented VP of Operations Doug Plassche.
Quote:
Doug Plassche
Okay. Actually it’s the [alarm] (ph). So let me walk you through it. I do believe I’ve covered this before. I apologize if you weren’t on the call or I did not emphasize them up. We made Isradipine at our facility in here at Northvale. We put it on stability. We created the CBE-30 and we filed it to the FDA. We had a strict feedback from center that they want us to – they said the CBE-30 is still open. We would like you to validate the process before you launch it. And they literally said to us, you can validate the process and launch and then notify us. So from their standpoint we can move forward.
The issues we encountered is the same issues that a lot public companies encounter. First, the API manufacturer was the only AP. We had single source API manufacturer in our application. So, in order for them to sell us product for us to go ahead and validate they requested first that we pay the PDUFA fee on their behalf. They were not using their DMF. So they wanted us to pay that. We paid it. It was like $36,000 or so.
Then they demanded that we buy all of the raw materials that go into making Isradipine. So we have to fork another chat for $125,000 and then we had to buy the entire lot from them, which we did and the entire lot was API which is lot of API and a lot of negotiations took place between Doug Plassche and these people in order to finally to get us the API. Now that we have the API Doug needs a prioritize it and I anticipate that we will go ahead and finish that edition and launch in Q4 of this year.
Great. That will make me more money. Nasrat knows best and we just have to let him do his job. Everyone just relax and get rich.
That's what the CEO said and I believe him. Anything else is just noise without links.
