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Crohn's Disease Forum » Treatment » Low Dose Naltrexone » TNI Biotech signs Agreement to Manufacture LDN


09-05-2013, 09:29 PM   #1
Jmrogers4
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TNI Biotech signs Agreement to Manufacture LDN

Sep 04, 2013 (ACCESSWIRE via COMTEX) -- BETHESDA, MD, September 4, 2013 - (Accesswire) - TNI BioTech, Inc. (otcqb:TNIB) and Laboratorios Ramos announced today that they entered a manufacturing and supply agreement for the production of Low Dose Naltrexone ("LDN") for commercial use. This agreement enables TNIB to focus on the development and commercialization of therapeutic treatments for cancer, HIV/AIDS and autoimmune diseases by combating these fatal diseases through the activation and modulation of the body's immune system. Under the agreement, TNIB and Laboratorios Ramos are responsible for the technology transfer, under a manufacturing agreement, and commercial production of LDN at the Laboratorios Ramos processing facility. Laboratorios Ramos operates "under the principles of the ICH" for cGMP and currently produces commercial products for sale in Nicaragua. The financial terms of the agreement have not been disclosed.
Full article - http://www.marketwatch.com/story/tni...ldn-2013-09-04

Can also be found on TNI biotech site here http://www.tnibiotech.com/
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Jacqui

Mom to Jack (18) dx Crohn's 2/2010
Vitamin D -2000mg
Remicade - started 1/9/14; 7.5ml/kg every 6 weeks
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Past meds: Imuran/Azathioprine; allopurinol; methotrexate; LDN; Prednisone; Apriso; Pentasa; EEN

Husband dx Crohn's 3/1993
currently none due to liver issues
09-06-2013, 09:10 PM   #2
akduck
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I wonder what this means for the cost of LDN and the shelf life that compounding pharmacies consider to be 90 days or less!
09-06-2013, 09:41 PM   #3
nogutsnoglory
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I am in favor of a well regulated and more controlled distribution of LDN. I wonder when this will be on shelves.
09-06-2013, 10:06 PM   #4
Jmrogers4
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TNI website says they are planning Phase III trials in 1st quarter of 2014 so hopefully soon
09-07-2013, 08:30 AM   #5
Kev
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I'm reading this with mixed emotions. I love the news that Phase III testing is scheduled for early 2014. Anyone any knowledge of what the typical timeframe for such testing is?

I don't know the pedigree behind the Nicaragua company. My ignorance and bias has me wondering if this was the best choice, or the least expensive. I would hate to think it was the latter. Maybe I'm superstitious, maybe I'm a pessimist at heart. However, I hope that this company was selected because it only operates under the highest set of standards that exist. The... risks... are just too great... to have a quality control issue set LDN back. No, not the ... risks... the results. If a bad batch of pills ever came out, it could hurt, perhaps even kill, this lifesaver in it's infancy. There are a lot of very high powered opponents to this drug out there... waiting for an opportunity to shoot it down, so every step TNI Biotech takes HAS to be above reproach. There might be no second chances. What does it take to make these pills? I don't know, but whoever does make them needs to have the highest credentials, the best possible credibility one can have.

In that documentary... watching a machine pump out LDN pills.. it made me smile. And, almost wish I lived there. Norway. OK, Noway. My limited understanding is... made that way, they have a shelf life of about a year. Sure would be nice to have that security.

As for cost... I pay out of pocket for them... but, if approved, and pumped out in major quantity by a reputable company... they 'should' have a DIN #, and hence be covered by insurance. In bulk, Naltrexone is cheap... I understand the investor will need to get their $150 million investment back. With interest. But, given the potential market for this drug... once it gains acceptance... imagine how many people with varying diseases will be lining up for theirs. The sheer numbers... well, it boggles the mind. And, with FDA approval... hopefully the big roadblock... will be removed. It may start as a trickle, but a flood will follow. Imagine it.. you are a patient with "X" disease, and you currently take a drug for it with a litany of side effects, long range pitfalls. Sitting next to you in the doctors waiting room is another patient, same disease... taking a perfectly safe pill, with excellent results. Is the first question you demand of your doctor is how much it costs? As for the doctor... what is she/he going to say? No? Why? What reason would you give credence to? FDA approved, safe, effective... versus another drug not as safe. If it passes FDA approval... (and this is my expectation.. but I misplaced my crystal ball, so I could be way off)... then the dynamic changes dramatically. Think about it. What possible reason COULD a licensed physican give to place a patient on a drug with higher risk of side effect when another, safer, APPROVED drug is available. Whatever reason a doctor MIGHT come up with, it had better be able to stand up to scrutiny in a court of law. Why? Simply because, if I was that doctors patient, and she/he placed me on any other drug, and I developed side effects, and found out there was a safer alternative, I would sue. And every doctor out there is going to be facing that potential prospect.

My guess... (and, unfortunately, history has taught me that I can't foresee the future), is that... slowly at first, patients and physicians will jump on the LDN bandwagon. Big time. You take away physician's reluctance to prescribe it, you take away any possible freshness or mis-compounding issues, you begin advertising this drug for all the diseases it can treat... and you end that advertisement with disclaimers.. vivid dreams, maybe some sleep disruption... can you picture the onslaught, the avalanche of requests for it?

If TNI Biotech was publically traded, I would invest in it...
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Dx'd July, 2006
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Low Dose Naltrexone Nov 2007 - May 2014
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09-07-2013, 09:56 AM   #6
nogutsnoglory
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I think a lot more gastroenterologist would feel comfortable prescribing LDN if it was a "real" drug. I think right now they don't know much about it and are hesitant.
09-07-2013, 11:35 AM   #7
Jmrogers4
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[QUOTE=Kev;699800
If TNI Biotech was publically traded, I would invest in it...[/QUOTE]
.
Get your checkbook out Kev TNIB $1.61

But I'm with you and hoping the quality vs. inexpensive wins out. I haven't had a lot of time to research the lab but was definitely going to see what I could find out
09-07-2013, 01:15 PM   #8
Kev
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Hmmm, I might just put my money where my mouth is... Unfortunately I happen to have more mouth than money. Hey, maybe LDN will change my life in more than just one way.
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