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Conversation with DPS concerning CBD/THC levels and current set of revisions for the TCUP

Phillip High - Thursday, March 17, 2016




Dear Ms. Boline,

Thank you for speaking with Mr. Phillip High, Medcan Director of R&D and myself today, over and above for sharing the updates from your office on the Compassionate Use Program. Additionally, your information on the subject of another set of regulation revisions and the fact that it will be posted soon was excellent news. Predominantly, because once again, as in the past, we will be allowed the opportunity to continue to insert our comments into this ongoing process; which by the way, is more than we expected; and though your professionalism has being part of the process, grateful we are.

More to the point, we appreciated your insight regarding the DPS taking into consideration the subject of the cannabis development process and the fact that cultivation is not an exact science as well as your agency affirmation that precise THC levels can be unpredictable; on the other hand, as discussed the refining of the oil/product at the medical laboratory level is clear-cut and precise. Consequently, as mentioned to you during our exchange of ideas THC levels can be controlled and once more it is reassuring that your office understands the process/methodology and is willing to work with the primary intention to allow us to produce quality medication for our Texas epilepsy patients. That being said, your comment that the legislation concerning “any low THC cannabis” is being interpreted by the DPS with great compassion, or in other words that as long as our flower is being legitimately used to produce the low-THC medication it will be considered to be in compliance; whereby, will not put our operations, managers, or growers in jeopardy. Perceptibly, we as operators must pledge to be incredibly concerned with our commitment to follow the spirit and the letter of the law.

Moreover, as mentioned the percentages by weight change dramatically when the oils are extracted from the plant material.  It is understandable that the initial language of the legislation, and therefore regulations, were based on percentages by weight.  As this is the way that cannabinoid (CBD and THC) concentrations are described in plants.  However, when dealing with oils and concentrates, there is no plant matter.  Therefore 100% of the weight is comprised of CBD and THC.  As you can see in the graphs, the 0.5% THC by weight, in the plant, jumps up to 5% by weight in the oil.

 

   

 

 

That is why we would suggest using ratios, instead of percentage by weight.  10%:0.5% is a ratio of 20:1.  However, if the 0.5% by weight is then applied to the oil, you end up with 99.5%:0.5%.  Which is a ratio of 200:1, thus bringing the amount of THC 10 times lower than what was truly intended under the spirit of the law of the SB 339 regulation, for the final medication! The below chart helps illustrates our opinion:

 

 


The 0.5% weight in the oil form is not impossible to obtain; nevertheless, it would be difficult to achieve and the operating cost could range into the millions for Texas SB339 operators.  To give you an example, the type of equipment needed, to refine the CBD oil to a purity of 99.5%+, would be the Waters SFC 350 Preparative System.  This system costs up to $350K and can only produce 100g of pure CBD per day.  This is only enough medication for 300 patients (at the estimated dosage of 300mg per day). Texas is the home of about 175,000 to 183,000 intractable epilepsy patients; however, because of the very low ratio of THC contained by SB 339 we estimate that only about 20% of our patients will benefit from the use of the medication, otherwise stated approximately 30,000 patients. Unfortunately, many epilepsy patients, such as Alexis Bortell, need a higher dose of THC for the medication to be effective and have subsequently moved to Colorado to obtain their medicine. Lowering the THC by a factor of 10, would prevent even more patients from being able to utilize medication in Texas.  So in order for the medication to be available to the estimated market (30,000 patients), we would need 100 such previously stated systems to genesis our Texas program.  That is an extra cost of $35 million in equipment, not even accounting for the highly skilled labor that would be needed to run such operations. Hence, it would greatly limit the number of businesses that could enter the industry but most importantly it would make the medication extremely expensive for the patients.  The beauty of using the initial 20:1 ratio, is that it can be applied to all areas and products without having the meaning change from one product to the next

I hope this observation helps to clear up our concerns.  I would be honored and/or delighted and available if necessary to break into any questions or assess any concerns you may have for further clarification on our report.

As a final point, we were pleased to hear that the DPS is still on schedule for obtaining bids for the registry as planned. Again, we appreciate all you are doing for our patients in Texas and look forward to continue working with you.

 

All my best,

Henry Levinski

VP of Operations

Medcan Foundation, Inc.

817.528.2475 MB

hlevinski@medcanfoundation.com


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