A BAKER'S DOZEN & A HORSE OF A DIFFERENT COLORMIGHTY MAVEN ANSWERS: Why is Tetra Bio-Pharma's ten new clinical trials on its cannabis-derived drug CAUMZ considered groundbreaking in the United States?LET'S CUT TO THE CHASE AND DIVE RIGHT IN:Let me jump right to the chase. According to the United States National Institute On Drug Abuse, “DEA registration can take, if you’re lucky, one year to obtain. That delays the process enormously and the process is VERY slow”, said Director Nora Volkow. She also criticized that there is only one legal source in the entire United States for research scientists to obtain cannabis for use in studies that attempt to shed light on the plant. The only place in the USA to obtain it is located in a facility at the University of Mississippi. Did you know and can you even imagine that!?AND ONE MORE THINGLet me add something the director forgot to mention. There's also the cost place on marijuana, cannabis, smoke, weed, grass, whatever you call it, through the facility. Let me tease you a moment before I divulge that. If you want to do a study with 1000 volunteers, you will need a thousand pounds of cannabis for a year or longer study. You think that's not a problem to grow, but the problem is they don't provide it for free to researchers. No. There's a price tag that has been added per pound that appears to be there just to stifle research.I KNOW. HARD TO BELIEVE. BUT HERE IT IS IN DOLLARS AND CENTS:I know you can't believe that would happen, but once you get your study ready for 1,000 participants at a university on the west coast or a multi-university study, and you contact U of M, and they tell you the price to conduct that study, just for the cannabis they would provide you, the bill for that one thousand pounds is one billion dollars. You read that right. For a multi-year study using a large number of participants, 1,000 participants, 1,000 pounds will allow you to give each participant one ounce pe month for 16 months of the study. If you conduct it in several universities across the nation and do a mega study with 2,000 participants for the best, most complete results on those 21 and older, for example, then 1,000 pounds of cannabis would allow each participant to have just half an ounce per month for 16 months. Who could ever have afforded to do that? And from what I've learned, the strains they have been selling are from forty years ago. Who would even want to study those? Why study a strain that's not even in use!MIGHTY MAVEN, HAVE YOU GONE LOCO?Okay, we get the math, you say. But a billion dollars? Street value of 1,000 pounds bought an ounce at a time is $1,000 a pound. Not counting discounts for volume purchasing, that's just $1 million dollars for 1,000 pounds, not a billion dollars. Plus, you say, you could probably buy 1,000 pounds for a fourth that price on the streets, maybe $250,000, and it's illegal, so has a markup for the risk which you shouldn't have if you are buying legitimately through the U of M, right? Why would it cost one billion dollars for a thousand pounds of cannabis coming from a university in Mississippi? I don't believe you, you say. Sure, I wouldn't believe me, either. Who could believe me? I must sound like a crackpot right about now. I can hear them saying, Change your name from Maven to Ravin'.I FORGIVE YOU ALL. I WOULD THINK THE SAME THING OF ME. BUT HERE'S THE FACT:Good to question my sanity at this point. But now you will see the reality of it. The real madness is because the University of Mississippi charges $1,000,000.00 for each and every pound they sell. I'm not making this stuff up. Reality is stranger than fiction! You can't make this stuff up! Did you calculate how much that is for an ounce of junk weed, not talking primo cannabis here at all, just weak, old time, weed from before World War II? Try $62,500.00. That's right. More than your car or house, basically, for one ounce of bunk weed. Why they do it, they say, is that this is done "to deter crime". How many of these pounds have sold, in decades? ZERO! Myself, I don't see this being a deterrent to crime, but to valid, sound research. So yes, if the University of Mississippi contracts with you for 1,000 pounds of cannabis to be used to research cannabis in FDA clinical trials, just the cost of the cannabis alone is going to cost you $1,000,000,000.00.PRELIMINARY CONCLUSION PER THE MADNESS IN MISSISSIPPI:So needless to say, Nobody wants to do a mega study on cannabis in the United States at this time. LET'S HEAR IT FOR TETRA BIO-PHARMA: HIP HIP HOORAY! SAVE THE DAY.Enter Tetra Bio-Pharma. With their approach, they are studying the effects of their CAUMZ(tm) drug, which is composed not of physical cannabis, but using synthetic THC and CBD, which is not required to be acquired from University of Mississippi. FDA has reviewed all of Tetra's clinical trials to date; they have reviewed all of Health Canada's commentaries on these studies; they have both gone through the results of each trial of Tetra's; they have seen the conscientious actions of Tetra Bio-Pharma leaders to safeguard clinical trial participants; and have rewarded them with a major invite to conduct their studies here in the United States, not just in Canada, and in a dozen locations or more, not just the one site in Canada."SO IS THERE ANYTHING THAT MAKES THIS EVEN MORE GROUNDBREAKING THAN THAT, IF ANYTHING CAN?:Yes, there IS more. First, that's what's so groundbreaking about the Tetra Bio-Pharma clinical trials being conducted in the United States at this time. In the first place, ZERO clinical trial sites are even set up to study cannabis because of the enormous cost just to buy the cheap quality grass offered through U of M. So nobody has even bothered to gain the DEA, FDA approvals necessary because who has a billion dollars? Who wants to buy an old Volvo for a million bucks from a junkyard? Nobody. It's been a no-brainer, so nobody even tries to get involved even though the world has been passing the United States by. We're not even in the race, fans! Rather, we weren't! But now the USA is in the race to study cannabis, and Tetra Bio-Pharma is leading the charge! But even more, yes, there IS more, it is even more groundbreaking than this, because this isn't just the initial Phase 1 study for safety and analyzing dose titration levels that will hopefully someday reach a possible late stage success. No. This is even more groundbreaking because it is a bonafide, major PHASE 3 clinical trial at major U.S. clinical trial sites. And another big reason for the upbeat, positive and expectant atmosphere at these sites is because they are doing this study which was bridged from another very successful Tetra Phase 3 study (on PPP001 smoked cannabis) in which the results coming in were statistically very significant, because FDA accepted their successful bridging of the PPP001 results to their synthetic cannabinoid (THC/CBD) study CAUMZ. So the odds of success look very promising, indeed. Some of these sites have been waiting for DECADES to initiate clinical trials on cannabis. DECADES. These sites have full disclosure access to the PPP001 study data and their conclusion was, We want to be a part of this Phase 3 bridged study.TETRA'S CAUMZ PATENT AND PHASE 3 BRIDGED RESULTS:The patent and successful results that came out of the PPP001 has many big pharma companies excited about working in the cannabinoid field, and in particular, working in partnership with Tetra. Most people are not aware of the fact that Tetra's successful results and the patent are extraordinarily RARE. Yes. Rare! According to "Clinical Development Success Rates 2006-2015", Bio, Biomedtracker, Amplion, new drugs for oncology treatment have the LEAST approval rate of any of the sixteen major categories analyzed. Hematology drugs have the highest success rate at 26.1% and Oncology has the lowest success rate at 5.1% Likelihood of Approval (LOA) from Phase I forward. Yet Tetra's stunning results and subsequent patent have the industry talking cannabis, no question about that. Perhaps Tetra needs to learn how to brag a little, do you think?HOW DO YOU PREDICT SUCCESS BEFORE A STUDY IS CONCLUDED?One thing that helps with predictability in a cannabis trial is that the drug and its anectdotal evidence has been known for centuries, even millenia. This is not the case with newly created molecules nobody ever heard of. While THC was, in the great scheme of time, recently discovered, it's effects have been known for thousands of years. When Tetra's studies began confirming what we already knew, this was a huge advantage over testing completely unknown medicine candidates. This is because you have so much more data you can use in your analysis to help with predicting the outcomes. When they tested Harvoni for Hepatitis C, the found out in three months of treatment, that people were being totally cured of it, but they couldn't do a press release stating that the clinical trial was successful, because that was still going on. But the fact that it was still going on, didn't mean they didn't know it was a raging success. They did know it. But they still had to complete the trial before it was announced a success because that's just how you do it. But at the early stages, partners were already coming in wanting to prepare for marketing, because they saw the results and knew it was being successful with all the first participants of the study. Could it's success have been due to regional variations, the drinking water, local diets? Anything is possible, but that wasn't likely nor was that the case. So the same thing with Tetra's PPP001 now called PPP011 and CAUMZ. LET'S TAKE A LOOK AT HARVONI, THE HEP C SUCCESS!See, these trials last for a year or more, that's true, but typically the participants, like with Harvoni, only took the drug for three months, not a year and a half or two. So you get to learn right away is it effective for this first group of people or not. Conversely, God forbid, if people drop dead from Harvoni, for example, you cancel the study immediately and don't continue it for another year and a half. Why not? Because you have incredibly strong evidence being generated with each and every participant, whether good or bad results, that tell you, either hey this is working or somebody call the ambulance. So get it out of your head that you have to wait to the end of a clinical trial to know if it works. You don't. You wait for that to know, Did it work for ALL the participants and to calculate all your percentages and statistics the most complete way you can.CONCLUSION:Tetra Bio-Pharma, with the aid of its major partner in this, Canopy Growth (CGC), (which acquired the Mighty Medic vaporizer used in Tetra's CAUMZA kit, when it acquired Storz & Bickle recently) and with the support of its large investor Aphria, a large Canadian licensed cannabis producer, is really performing on its operational and expansion-development goals into the U.S.A. in 2019 and into 2020. And their CAUMZ drug has produced some awesome results. If not, they wouldn't have been able to obtain a patent with the data results and these big pharma partners wouldn't be coming around, and Tetra wouldn't be talking about CAUMZ the way the are. Let me just comment on the upbeat atmosphere seen at Tetra and its partner clinical sites, that 60% of all clinical trials that reach this Phase 3 stage are successful in Phase 3. But when you factor in for the clinical trial experience of those running those clinical trials, the success rate shoots up from there because, frankly, practice makes perfect and experience matters. One must remember that Dr. Guy Chamberland and Dr. Raphael Mechoulam, the renowned Father of Cannabis Research, and other collaborators in this are some of the brightest minds in the industry, internationally. And a last thought on experience is that anecdotal experience can be very revealing of the truth and should never be neglected just because it wasn't produced scientifically, since conclusions from it, whether deductive or inductive or otherwise, can turn out to be 100% in agreement with later, scientific studies. Every day more people claim cannabis works to help their families get through cancer symptoms of pain and nausea and starvation. Because of all of this, I will on record here that I see no other conclusion for the CAUMZ study than a complete success. Tetra news is groundbreaking for patients, their families, science and investors.
It's important to note that in the reference work above, for success rates for going from Phase 3 to NDA/BLA phase via successful completion, the Chronic High Prevalence Conditions average is success rate is 61%, and the Rare Diseases Condition is 73% success rate. That's 3 to 1 odds, this last one.* NDA new drug application* BLA biologic license application
Add to that the real expertise of Dr. Chamberland with this very sort of thing, yes, I am very confident about it.
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