Replies to post #219743 on Elite Pharmaceuticals Inc (ELTP)

[KravMD]

Great post!

[virelle]

Thank you to send this message to the FDA , senators and the FBI ! The overdose epidemic in usa kills tens of thousands of Americans each year , dozens each day ! The FDA is a criminal and corrupt administration.

[whatdoyouseek]

Exactly, but I don't see any reasons for the FDA (individual(s)?) to change their stance as long as not doing so is beneficial to them. That is my concern. Eltp do not have enough muscles to overcome, I am afraid.

[namtae]

NONSENSE

FACT: ALL IR opioids have THE SAME T-Max “issue”

All IR opioids arent ADFs!!

The other drugs referenced make no claim to be ABUSE DETERRENTS

More specifically, Sequests primary purposes are immediate relief of pain and an abuse deterrent. To that end, when fatty meals are introduced, not only is immediate relief compromised, Sequest also places the user at additional risk of OVER DOSING

The distinction being Sequest is an IR, which means the user is taking Sequest because pain is present

Sequest is forcing the user to make a decision: Should I suffer in pain or take more pills??

The antithesis of what the FDA wants for its first IR ADF opioid

[whichever]

Great post. Info for Robert Califf:

http://www.naturalnews.com/053219_Robert_Califf_FDA_head_Big_Pharma.html

[dr_lowenstein]

sorry that is not correct. Lets see what the FDA said:

here is what the FDA review said:

Sept 10, 2015 FDA comments re Avridi:

• When taken with food
–
Absorption of oxycodone from AVRIDI is substantially delayed.
•
AVRIDI Tmax: Median 4h; Range 1 – 9 h.
•
Roxicodone Tmax: Median 1.5 h; Range 0.5 – 4 h.
–
Oxycodone exposure with AVRIDI is low over 4 – 6 hr compared to Roxicodone
• As demonstrated by substantially lower partial AUC.
–
AVRIDI takes longer to achieve comparable systemic exposurecompared to Roxicodone.
–
Existing IR products do not show delayed Tmax to this extent.

ouch!!!! I would have thought that our A team would have realized they had an issue in Sept, 2015, but.....apparently not

[hondobud]

Elichen- Added some info to your previous post, so well written-

FACT: ALL IR opioids have THE SAME T-Max “issue”—i.e. fatty meal slows down absorption. So the same safety labeling used by other FDA approved opioids (including Opana IR Oxymorphone) should similarly be sufficient for SequestOx! NAMELY “TAKE ONE HOUR BEFORE A MEAL OR TWO HOURS AFTER A MEAL. TAKE NO MORE THAN 2 PILLS EVERY FOUR HOURS”.

THERE IS NO MEDICAL REASON to make the rules for dealing with the SequestOx T-max situation any different than for any other IR Opioid pain med!!! There is no more chance of over-dose on SequestOx than for any other IR Opioid pain med!! FDA KNOWS THIS! THAT IS WHY FDA IN 2014 TOLD NASRAT THAT LABELING INSTRUCTIONS WERE ALL THAT WAS NEEDED TO DEAL WITH THIS T-MAX ISSUE!

The FDA did a switcheroo at the last minute (after having granted ELTP a $2.5 million fee waiver and after having granted ELTP priority review). THERE WAS NO MEDICAL REASON for this switcheroo! THERE IS NO MEDICAL REASON why full approval was not granted on July 14th!!! It was obviously a politically (and/or financially) motivated decision in order to stall the entrance of SequestOx into the marketplace (or for some other politically motivated reason. FDA director Robert Califf was well known to Congress as a BP lobbyist before his appointment so it seems likely that conflict of interest was involved But additional political reasons also possible).(See No2Kool-Aids posts on this).

However, other political pressures exist to strongly motivate Califf to approve SequestOx because Congress wants ADF opioids to be available to replace non-ADF opioids that are causing so much abuse, death and enormous cost to the American people. Therefore, it is in Califf’s best interests to soon grant approval for SequestOx, which he will do. Our guy Eugene will get this problem resolved just like he’s previously gotten many other difficult problems resolved.

Federal House Health subcommittee members need to know about the stupid FDA decision blocking implementation of this ADF.

Jurisdiction:

Public health and quarantine; hospital construction; mental health; biomedical research and development; health information technology, privacy, and cyber security; public health insurance (Medicare, Medicaid) and private health insurance; medical malpractice and medical malpractice insurance; the regulation of food, drugs, and cosmetics; drug abuse; the Department of Health and Human Services; the National Institutes of Health; the Centers for Disease Control; Indian Health Service; and all aspects of the above-referenced jurisdiction related to the Department of Homeland Security.

Investors start calling representatives and voice your displeasure with the FDA bureaucracy.

Republican Members

Joseph Pitts (Pennsylvania - 16) - Chairman Phone: [phone]
Brett Guthrie (Kentucky - 02) - Vice Chairman Phone: [phone]
Ed Whitfield (Kentucky - 01) phone: [phone]
John Shimkus (Illinois - 15) Phone: [phone]
Tim Murphy (Pennsylvania - 18) Phone: [phone]
Michael Burgess (Texas - 26) Phone: [phone]
Marsha Blackburn (Tennessee - 07) Phone: [phone]
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Morgan Griffith (Virginia - 09) Phone: [phone]
Gus Bilirakis (Florida - 12) PHONE: [phone]
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Chris Collins (New York - 27) Phone: [phone]
Joe Barton (Texas - 06) - Chairman Emeritus Phone: [phone]
Fred Upton (Michigan - 06) - Ex Officio Phone: [phone]


Democratic Members

Gene Green (Texas - 29) - Ranking Member Phone: [phone]
Eliot Engel (New York - 16) Phone: [phone]
Lois Capps (California - 24) Phone: [phone]
Janice Schakowsky (Illinois - 09) Phone: [phone]
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Kathy Castor (Florida - 14) Phone: [phone]
John Sarbanes (Maryland - 03) Phone: [phone]
Doris Matsui (California - 06) Phone: [phone]
Ben Lujan (New Mexico - 03) Ph: [phone]
Kurt Schrader (Oregon - 05) [phone]
Joseph Kennedy (Massachusetts - 04) phone: [phone]
Tony Cárdenas (California - 29) phone: [phone]
Frank Pallone (New Jersey - 06) - Ex Officio Phone: [phone]


https://energycommerce.house.gov/subcommittees/health-114th-congress

Investors start calling Senators and voice your displeasure with the FDA bureaucracy.

Senate subcommittee on health:

Chairman (R)
Patrick J. Toomey (PA) Phone: [phone]

Chuck Grassley (IA) Phone: [phone]
Pat Roberts (KS) Phone: [phone]
Michael B. Enzi (WY) Phone: [phone]
Richard Burr (NC) [phone]
Dan Coats (IN) [phone]
Dean Heller (NV) Phone: [phone]
Tim Scott (SC) Phone: [phone]

Ranking Member (D)
Debbie Stabenow (MI) [phone]

Maria Cantwell (WA) Phone: [phone]
Robert Menendez (NJ) 202.224.4744
Benjamin L. Cardin (MD) Tel: [phone]
Sherrod Brown (OH) [phone]
Mark R. Warner (VA) Phone: [phone]

http://www.finance.senate.gov/about/subcommittees/#health