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namtae

10/11/16 7:12 PM

#229618 RE: cicle1 #229617

Maybe Elite can land a $20b generics manufacturing deal too

I mean, as long as everyone is fantasizing, why not go all the way

If people are risking $$ on Elite getting FDA approval for Sequest, they might as well put a flamethrower to it. This thing is so far off, if ever....and if ever ever comes, its gonna be way down the ladder of previously approved IR ADFs or non opioid pain killers

Plenty of stocks that go up for reasons... ELTP shouldnt be as high as 15 cents even with FDA approval

Thats another story for another day

Couch

10/11/16 7:21 PM

#229619 RE: cicle1 #229617

Well no reason to think that Elite's ER products have a fatty meal TMax issue-

What does this tell you???

http://labeling.pfizer.com/ShowLabeling.aspx?id=694

2.1 Initial Dosing
EMBEDA should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
EMBEDA 100 mg/4 mg capsules are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.
Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy with EMBEDA [see Warnings and Precautions (5.2)].
EMBEDA capsules must be taken whole. Crushing, chewing, or dissolving EMBEDA capsules will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.2)]. Patients who are unable to swallow EMBEDA should be instructed to sprinkle the capsule contents on applesauce and immediately swallow without chewing [see Administration of EMBEDA (2.4)].