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...