The delay should only be a few weeks ? What delay ? Who said that ?
Are you saying the FDA said we are going to delay our response to the Attorney Generals?
What am I missing ? To me , taking this long to respond indicates indecision someplace.
I mean if the FDA is so steadfast in their position it shouldn't take going on two weeks to respond should it ?
I just ran across this in an article........."Among the advisory board's other objections: Zohydro's manufacturer, Zogenix, disregarded FDA recommendations that opioid painkillers include a gel-like plastic preventing them from being crushed and snorted "
Is this what the AGs are pounding on the FDA with ?
Watching the stock today it seemed to be acting pretty good, but it kept running into a brick wall. I wouldn't think there would be such a strong brick wall if this is a slam dunk. Any thoughts why the FDA is contemplating for so long to respond ?
The two panel members who voted for the drug argued that Zogenix has met the FDA's safety standards and posed no greater risk than current painkillers on the market. The FDA agrees. "FDA has concluded that the benefits of Zohydro ER outweigh its risks when used as provided in the approved labeling," Licinsky, the FDA spokesman.
Liscinsky, a spokesperson for the FDA, confirmed that Zohydro "is not abuse-deterrent," but noted that "FDA does not believe it is feasible at this time to require that all new solid oral-dosage form opioids have abuse-deterrent properties."
"So, you were a mental midget 22 hrs ago and beyond but not just right now?"
I am more interested in making MONEY than idle bull(s)hit banter back and forth here.
That is history, in case you haven't noticed things are improving, we are trying to turn this into a board we can share USEFUL information.
WITHOUT spending the majority of time DIGGING under a pile of trash.
We ALL now know the strategy of the multiple alias bashers.
They want INTERACTION.....just like YOU are now giving them.
Can you give ONE legitimate reason for BUMPING their trash to the top ?
aicdeftone•Dec 14, 2013 11:30 AMFlag
Straight from Bob Rappaport, a director at the FDA in regards to questions as to why the agency approved Zohydro despite the boards recommendation not to:
"Punishing this company and this drug because of the sins of the previous developers and their products, from a regulatory standpoint, that's something we CAN'T do." "We are OBLIGATED at the agency to operate within the regulatory framework and that includes providing a level playing field for industry. We don't have a choice by that. IT"S THE LAW."
shorts and bashers, does this make sense?
Hey shortiesuck........This is the kind of stuff the LONGS here need to read, NOT one-liner garbage back and forth with a basher.
Do you realize he is making you look like a mental midget every time you BUMP his trash to the top ?
Do you have money in this stock ?
Also read the second part of this that is below......it wouldn't all fit on one post.
So quit bumping the garbage to the top. Don't waste your time and OURS with trash, find something good and useful to post.
YOU are doing the BASHER a favor by helping them to BURY everything else here.
I give up I'm not wasting my time looking up stuff to be piled under a pile of basher junk , the BASHER wins.......but with help from the LONGS that want to back and forth with them.
I have seen a few people here looking up ENDO and hollering it's a 2 cent stock, ENDO is a 2 cent stock.....but it's NOT Endo Pharmaceuticals.
ENDP Is the correct stock symbol.
Every single time we respond to them in any way shape or form we are helping them in their Mission.
Their Mission is to bury any worthwhile post that has beneficial information, and it is very easy for them to do if we keep responding to them and bumping their garbage to the top.
I for one am not going to respond to them anymore, or mention their aliases, or taunt them. or goad them to get a reaction from them.
The tide is turning against them, and we knew it would, for me that is good enough.
It is frustrating for someone to go through the trouble of finding something, posting it here ........only to see it buried under pages of trash talk, and forgotten all about. I know I've done it myself.
So we have to make this Mission Impossible for them, don't assist them in making this into a dump.
This is about money, our money.
This is very obvious to me where ZGNX is going to wind up. This is no coincidence that Dr. Galer is now with ZGNX, look at the drugs that ENDP has. Any of them look familiar ? Well known ?
Many times a buyout prospect , a bigger company, or the interested acquirer will have an employee, or former employee gain a management position in the company they are interested in.
Around where I live is the home base for Medtronic (MDT) and St Jude Medical (STJ) , over the years I have had both of these stocks, MDT once, and STJ three times.
Both companies have a history of an employee, or former employee gaining a management position in a company they are interested in........and within six months or less they acquire that company. Many of the companies they acquired were right here in the area.
I would not be one bit surprised that Zogenix is going to either be a partner with Endo Pharmaceuticals (ENDP) or an acquisition.
Dr.Bradley Galer now being at Zogenix is a definite tell.
This wa cut off the end of the article.
Abuse deterrent formulations are an important tool to help address misuse of medication. In addition, both prescriber and patient education is vital to safe and effective opioid use. FDA encourages all opioid prescribers to take advantage of valuable training, available as of March 1, 2013, to help ensure they have adequate and up-to-date training in opioid therapy. FDA urges all prescribers to ensure patients using opioids are appropriately informed of the risks and benefits of these drugs and fully understand directions for their use. The opioid drug labeling also provides prescriber information related to patient education.
What does this tell you concerning the current attorney general BS ?
That BIG Pharma is behind petitions to not allow competing drugs.
And what did the FDA do.........they said forget about it.
And that is the same thing that is going to take place with this attorney general BS.
This picture is now coming into focus.
Good Luck Longs !
FDA Statement: Original Opana ER Relisting Determination
The U.S. Food and Drug Administration (FDA) today responded to a petition and decided that the original formulation of Opana ER (oxymorphone hydrochloride) Extended-Release Tablets was not withdrawn from the market for reasons of safety or effectiveness. As a result, generic versions of the original formulation can continue to be approved and marketed.
The petition was submitted by Endo Pharmaceuticals Inc., the sponsor of original Opana ER and a reformulated version, also called Opana ER, which was designed with the goal of being more difficult to abuse and misuse. After an extensive, science-based review, FDA concluded based on the available data and information that the original formulation of Opana ER was not withdrawn from the market for reasons of safety or effectiveness. As a result, FDA has denied the manufacturer’s petition.
FDA conclusions include:
While there is an increased ability of the reformulated version of Opana ER to resist crushing relative to the original formulation, study data show that the reformulated version’s extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing.
Reformulated Opana ER can be readily prepared for injection, despite Endo’s claim that these tablets have “resistance to aqueous extraction (i.e., poor syringeability).” It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods.
The postmarketing investigations are inconclusive, and even if one were to treat available data as a reliable indicator of abuse rates, one of these investigations also suggests the troubling possibility that a higher percentage of reformulated Opana ER abuse is via injection than was the case with the original formulation.
FDA continues to encourage the development of abuse-deterrent formulations of opioids to help reduce
This Is Endo Pharmaceuticals (ENDP) A $7.44 BILLION Market Company with $3 BILLION In Sales
Endo Health Solutions Inc. provides specialty healthcare solutions in the United States and internationally. The companys Endo Pharmaceuticals segment offers branded prescription products, including Lidoderm, Opana ER, Percocet, Voltaren Gel, Frova, Supprelin LA, Vantas, Valstar, and Fortesta Gel for pain, urology, endocrinology, and oncology. Its Qualitest segment provides non-branded generic products in the pain management, urology, central nervous system disorders, immunosuppression, oncology, womens health, and hypertension markets. The companys AMS segment offers various technology solutions comprising AMS 700 MS series, AMS 800 artificial urinary sphincter, GreenLight XPS laser system, Elevate transvaginal pelvic floor repair system, and Monarc subfascial hammock products in the areas of mens and womens health, and BPH therapy. Its HealthTronics segment provides urological services, such as lithotripsy, prostate treatment, anatomical pathology, and electronic medical record services to urologists, hospitals, surgery centers, and clinics; and manufactures, sells, and maintains medical devices for tissue and tumor ablation. The companys products under development primarily include Aveed, an injectable testosterone preparation to treat male hypogonadism; BEMA Buprenorphine, a transmucosal form of buprenorphine in Phase III trials for treating moderate to severe chronic pain; ODM-201, an androgen receptor antagonist in Phase II clinical testing to treat castrate resistant prostate cancer; and EN3342, a polyurethane implant in Phase I/II trials for the maintenance treatment of schizophrenia in adults. It serves pharmacy chains directly; and hospitals, governmental agencies, pharmacies, and physicians through wholesale drug distributors. The company was formerly known as Endo Pharmaceuticals Holdings Inc. and changed its name to Endo Health
August, Bradley S. Galer, MD joined Endo as Vice President, Scientific Affairs. Dr. Galer will provide technical leadership and direction to the departments of Clinical Research, Medical Affairs, and Clinical Development & Education. As the company's senior medical officer, he will be the primary interface between Endo and opinion leaders in pain medicine and will be the primary liaison with the FDA on clinical issues. He will ensure medical/technical support to marketing, will have ultimate responsibility for the evaluation of the safety of Endo's products and will provide medical/technical advice to management. Prior to him joining the company, Dr. Galer was actively involved in the approval of Lidoderm, as both a principal investigator and consultant.
Dr. Galer received his M.D. from Albert Einstein College of Medicine in New York. He served his internship at Kaiser Foundation Hospital, his residency in Albert Einstein's Neurology Program, and Pain Fellowships at both Memorial Sloane-Kettering Cancer Center and University of California San Francisco. He obtained his B.A. in Biology-Psychology at Wesleyan University, Middletown, CT.
Dr. Galer comes to Endo from the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center, New York where he was Director of Clinical Studies and Co-Director, Nerve Pain Disorders Clinic.
Dr. Galer is a founding member of, and was chairman for, the Pain Medicine Section of the American Academy of Neurology over the past two years. He has published over 100 articles and book chapters regarding pain management and pain pharmacotherapy. He is a co-chair of the annual International Neuropathic Pain Conference. In addition, Dr. Galer holds academic memberships in a dozen medical societies, including the International Association for the Study of Pain, The American Academy of Pain Management and the American Academy of Neurology. He was named in the 1998 Best Doctors in America for Pain Management/Neurology.
You actually think we have a problem with WHY the stock is going up?
You better get a new writer, you really suck at bashing.