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Canada pop = 35,000,000
Extrapolate to USA @ 330,000,000 = $1.4 to 2.4 billion
then add Europe, China etc..
Prescription EPA Substantially Lowers Cardiovascular Risk in People with T2D
https://www.type2nation.com/treatment/prescription-epa-substantially-lowers-cardiovascular-risk-in-people-with-t2d/
He's a botox dermatologist in Vegas....check out the Yelp reviews:
https://www.yelp.com/biz/ken-landow-md-las-vegas?sort_by=date_desc
Is Amarin's presentation considered "Late-Breaking Clinical Trials and Featured Clinical Research" or "Posters and Oral Presentations"?
The former is embargoed til presentation. Posters and Oral Presentation 2 weeks prior.
GENERAL EMBARGO
POLICY
Late-Breaking Clinical Trials and Featured
Clinical Research are embargoed until
the start of the session in which they are
presented. Posters and Oral Presentations
are embargoed until official publication
in the meeting proceedings, which is
approximately two weeks before the start
of the meeting. Some abstracts may be
held longer or released earlier to support
additional media promotions.
Correct.
It's in the "To be pursued" category...China could be pretty big though I would think.
International expansion
- Commercial partners pursuing regulatory approvals for Vascepa in Canada, China and Middle East
- Vascepa recently approved for sale in Lebanon and in United Arab Emirates
- Partners in other geographies outside the United States to be pursued
Kind of amazed no comments to this?
May I ask the board to speculate as to the root cause of the delayed TMax?
Is it the capsule itself?
Is it the OXY bead? Does it have a coating? Why would the OXY bead need a coating? To help make it look like the NAL bead?
sprinkling...
its what worked for light meals.
its an option Avridi did not have.
Other option of course is back to drawing board and reformulate/re-source the capsule or Oxy bead to release faster.
Great question.
SequestOx has a Tmax delay and can't get approved as a result and these two have a Tmax delay and remain approved? Shouldn't the FDA pull these two?
The FDA has data on the SequestOx delay w/ fatty food with the pill intact. And they found the delay "unacceptable".
What is unacceptable?
These two have delays of a minimum of 1 hour...
Well. That sucks. Retirement will take a while longer.
I'm 20 minutes away. How I do I go about doing that? Ring the doorbell? Hey you get approval? Or do I just look for smiling faces and high fives?
ELTP
"L'audace, l'audace, toujours l'audace!"
They reserved the domain name.
I imagine a website is in development that would be launched following approval.
I imagine any such website would have that info.
Should be along the lines of the website for mbeda...http://www.embeda.com/
Trademark Designation: http://www.tmfile.com/mark/?q=866570280
Website reserved: sequestox.com http://www.whois.com/whois/sequestox.com
That's some circular argument.
So because Zogenix no longer "has" the drug that leads to a conclusion that they lied about the size of the IR vs. ER market?
It proves it accurate however. Zogenix would not deliberately lie about the size of the IP market vs the size of the ER market.
So you disagree with the IMS figures that state IR in 2014 was 88.7% of the market?
The IMS will be very upset someone is questioning their stats.
No but it validates it.
The FDA was the source. Keep reading.
Here is a more up to date slide deck from the FDA:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/UCM489209.pdf
See slide 5
I will keep throwing up links til you are satisfied.....
How about this from the FDA. See slides 7 through 12.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM220950.pdf
This is older ...2009....bit I doubt the IR market share has changed much since then.
I'll keep looking.
The pocket veto is the only type of veto that is not subject to override. However, it only applies only to bills passed within the last 10 days of a 2-year legislative session.
http://politickernj.com/2013/02/understanding-the-power-of-the-veto/
Rep Vitale will be re-submitting this in such a way that CC won't be able to pocket veto it again. He may use a regular veto but those can be overridden.
So much for "futures" predictions...
Opioid Prescribing and Pain Management
2015 Legislative Summary
https://www.aapmr.org/docs/default-source/advocacy/pain-management/2015-state-opioid-update.pdf?sfvrsn=6
http://www.marshalldennehey.com/media/pdf-articles/O%20414%20by%20M.%20Rydzewski%20%2805.11.16%29%20NJ%20Law%20Journal.pdf
On Jan. 11, the New Jersey Legislature
passed Bill A4271, which would have
required health insurers to provide
coverage for ADOs. Shortly thereafter, on
Jan. 19, A4271 was pocket-vetoed because
the estimated cost to the state (over $11
million per year) outweighed what is
currently known about ADO effectiveness.
Since that time, on March 10, the U.S.
Senate cleared the Comprehensive
4
Addiction and Recovery Act of 2016 (S.524).
The act is under consideration by the House
at this time. If enacted, the act would
authorize the U.S. Attorney General to
award grants to states to support
comprehensive opioid abuse response
initiatives. If enacted, the act could provide
more resources to New Jersey such that
A4271, if reintroduced, may become more
financially feasible.
Seat-belts won't save every life yet their use is mandated by law.
Same will go for ADF's.
And yet here we are. Up over 400% and just two short weeks from PDUFA date.
Yes, it's called financing. Look it up.
Geez.
Who would take a 63% annualized return on their investment?
Elite signed the LPC deal in April 2013 when Elite was .07/share.
Today it is .33/share.
So yea, I feel pretty damn good about LPC.
FDA Ad Comm set for August 4 to review Egalet's NDA for abuse-deterrent opiod ARYMO ER
http://seekingalpha.com/news/3190817-fda-ad-comm-set-august-4-review-egalets-nda-abuse-deterrent-opiod-arymo-er
Jun 28 2016, 10:17 ET | About: Egalet Ltd. (EGLT) | By: Douglas W. House, SA News Editor Contact this editor with comments or a news tip
A joint meeting between the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will take place on August 4 to review Egalet's (EGLT +2.9%) New Drug Application (NDA) seeking approval of ARYMO ER (morphine sulfate) extended-release tablets, an abuse-deterrent formulation of morphine, for the long-term management of pain.ARYMO ER incorporates the company's abuse-deterrent Guardian technology, which utilizes a plastic injection molding process to make the tablets extremely hard, difficult to chew, resistant to particle size reduction and inhibits attempts to chemically extract the active pharmaceutical ingredient. In addition, when exposed to a liquid, the tablet forms a viscous hydrogel which makes it difficult to draw into a syringe.The FDA's action date (PDUFA) is October 14.
0.326 x352,500
She lives 5 minutes from my office. Want me to say "Hi!" ?
I am on the call right now.
Elite has an efficacy trial....