Billy -- you sound like a ogre -- like the biggest fattest cave Ogre in the Lord of the Rings post-trilogy movie when Bilbo helps the Dwarves by becoming their burglar.
From your repeated bullying, lard-throwing comments here one can only surmise that you are the most odious person in the world, unfit for human society. And so, inflicting the flatulence that continuously emanates from your mouth is your revenge on others for being born.
When you could be helping, befriending and connecting yourself to others, you choose to enter and hover like a foul, toxic cloud of gaseous excrement. I shudder to think of the horrendous, anally-fixated deliverance family you must have come from.
When you die, your funeral will likely consist entirely of those wishing to share their bodily excreta with you in the afterlife, to feed the fire that awaits you.
How much of your bagholder equity did you lose this last week, excremouth?
No one here knows what they FDA really Said.
more likely still 0.30 or less --- Bet you they will increase OS and that is the deal killer.
That way you could actually chart the effect on Nasrat's words on PPs. --- A correlation he obviously did not want you poor folks to see.
bag holders are those who selectively focused on the possibility of FDA Approval while simultaneous ignoring the probability of denial, which is always greater for a small company like Elite. And greater still when that company is run by a crazy guy who crashes PPS every time he speaks.
Yea, there some deck furniture you should go and re-arrange for a few more weeks. Don't forget your rubber duckies and remember to bring your wet-suit..
The CRL won;'t directly say this, but ti will raise ancillary issues and demand new safety studies.
The big issue is: There are numerous potential usage scenarios that have never been tested for safety.
Anyone who thought that Opioid plus Naltrexone was just going to be thrown out into the market was delusional. Naltrexone may be even more dangerous than the opioid.
YES -- It's good they've closed the doors on the TITANIC's unsinkable water-tight compartment system.
But it's bad that the 'Water Tight" compartments aren't.
Can barely wait to hear the spin session.
Elite Pharmaceuticals, Inc. to Host Conference Call to Discuss SequestOx™ Complete Response Letter on Monday, July 18, 2016 at 8:30 AM EDT
NORTHVALE, N.J., July 16, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing a pipeline of abuse-deterrent opioids and niche generic products, announced today management will host a conference call to update investors on the Complete Response Letter (the "CRL") issued by the U.S. Food and Drug Administration (the "FDA") regarding the New Drug Application (the "NDA") for SequestOx™ (oxycodone hydrochloride and naltrexone hydrochloride), Elite's investigational abuse-deterrent opioid candidate for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.
Conference Call Information
Date: Monday, July 18, 2016
Time: 8:30 AM EDT
Dial-in numbers: 1-800-346-7359 (domestic)
Conference number: 98840
Advise patients that if they previously used opioids, they may be more sensitive to lower doses of opioids and at risk of accidental overdose should they use opioids after Naltrexone hydrochloride treatment is discontinued or temporarily interrupted. It is important that patients inform family members and the people closest to the patient of this increased sensitivity to opioids and the risk of overdose.
Advise patients that because Naltrexone hydrochloride can block the effects of opioids, patients will not perceive any effect if they attempt to self-administer heroin or any other opioid drug in small doses while on Naltrexone hydrochloride. Further, emphasize that administration of large doses of heroin or any other opioid to try to bypass the blockade and get high while on Naltrexone hydrochloride may lead to serious injury, coma, or death.
Patients on Naltrexone hydrochloride may not experience the expected effects from opioid-containing analgesic, antidiarrheal, or antitussive medications.
Patients should be off all opioids, including opioid-containing medicines, for a minimum of 7 to 10 days before starting Naltrexone hydrochloride in order to avoid precipitation of opioid withdrawal. Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as two weeks. Ensure that patients understand that withdrawal precipitated by administration of an opioid antagonist may be severe enough to require hospitalization if they have not been opioid-free for an adequate period of time, and is different from the experience of spontaneous withdrawal that occurs with discontinuation of opioid in a dependent individual. Advise patients that they should not take Naltrexone hydrochloride if they have any symptoms of opioid withdrawal. Advise all patients, including those with alcohol dependence, that it is imperative to notify healthcare providers of any recent use of opioids o
It's not a minor corrective --- It will be significant.
The delay along will cost the company tens of millions of dollars.
ELTP with 750 Million OS just went from being a Highly Questionable investment to one in which the Answer to that question is: NO
Really, DA. then go buy some.
Naltrexone FACTs and WARNINGS:
What Nasrat has done is combine an already unsafe opioid with another drug (Naltrexone) that has safety issues of its own. You can't expect the FDA to rubber stamp that. It's going to require more studies.
Oh, c'mon -- you're so far out there.... you could audition for the next iteration of LOST IN SPACE.
Maybe his punctuation on the App was bad.