Scottsdale Research Institute

5436 E Tapekim Rd, Cave Creek AZ 85331 USA

Phone: +1 (480) 326-6023

June 12, 2019

Scottsdale Research Institute Requests U.S. Court of Appeals for the District of Columbia
Circuit to Order the U.S. Attorney General and the Drug Enforcement Administration to
Process Its Application to Cultivate Cannabis for Clinical Research

Cave Creek, Arizona—This week, Scottsdale Research Institute (SRI) asked the U.S. Court of
Appeals for the District of Columbia Circuit to order the U.S. Attorney General William and the
U.S. Drug Enforcement Administration to process its application to cultivate cannabis for its
clinical research. SRI’s clinical trials focus on whether medicinal cannabis can treat veterans
suffering from otherwise untreatable PTSD.

For decades, DEA has required federally approved researchers like SRI to use cannabis
produced by the University of Mississippi. This cannabis, however, is distinctly different from
the cannabis found in medical cannabis dispensaries around the country. SRI used it for Phase II
trials, and found it was not appropriate for clinical research.

Almost three years ago, SRI applied to grow its own cannabis for clinical research under strict
government protocols. Yet, the DEA has ignored repeated requests from SRI and at least seven
letters sent by members of Congress from both parties questioning DEA’s delay.

Below are statements from SRI Principal Investigator Dr. Sue Sisley and Matthew Zorn and
Shane Pennington of Yetter Coleman LLP, a trial and appellate boutique located in Houston, TX,
representing SRI in the matter. SRI’s filing can be found at www.admin.law.

Statement from SRI Principal Investigator Dr. Sue Sisley:

While most states in the U.S. recognize that cannabis has medical value, the DEA says
otherwise, pointing to the absence of clinical research. But at the same time, government
regulations and bureaucracy prevent researchers like SRI from ever doing the clinical research
the DEA has overtly demanded.

It took us seven years to obtain government approval to investigate the safety and efficacy of
cannabis to treat veterans with treatment resistant PTSD. And the difficulties in doing the
research did not stop there. The only legal source of cannabis in the U.S. for clinical trials comes
from the federal government. We used it for our Phase II trials. What we found was that it was
wholly inadequate for serious clinical research. It looks nothing like the cannabis that can be
found in medical cannabis dispensaries around the country and is so bad that it sabotages the
research.

Back in October 2016, we submitted an application to manufacture cannabis for our clinical
trials, but the DEA has not responded to our application. In the meantime, SRI and all the other
cannabis researchers in the country are forced to continue using this sub-par cannabis, or
 Scottsdale Research Institute
5436 E Tapekim Rd, Cave Creek AZ 85331 USA
Phone: +1 (480) 326-6023
import it from foreign countries like Canada. We’ve made numerous attempts to urge DEA to
move forward on our application and its August 2016 pledge to support cannabis research in
the U.S. by licensing other growers for research. Members of Congress from both sides of the
aisle have written no fewer than seven letters to the agency asking for updates. We’re still
waiting to hear back, and unfortunately, because of this delay, our research stagnates.

We were hopeful that we could put sufficient pressure on the new Attorney General so that the
DEA would license new cannabis producers for research before Summer 2019. But there’s been
no progress, despite years of lobbying, so we are now seeking a remedy through the courts. We
filed an action in the U.S. Court of Appeals based in Washington, D.C. asking the court for an
order compelling the DEA to process our application. We hope that this recent filing in the D.C.
Circuit encourages the DEA not only to process our application, but to process the applications
of others, so that we can all continue to do important research into the safety and efficacy of
cannabis for treatment resistant illnesses.

Statement from Yetter Coleman LLP Attorney Matthew C. Zorn:

This is a case about the DEA disregarding the law to delay important research to explore the
potential of cannabis to treat our nations’ veterans suffering with treatment resistant PTSD. As
we lay out in detail in our filing, there is simply no excuse for the agency’s two-and-a-half year
delay in processing SRI’s application to manufacture cannabis for its clinical trials.

Many still do not understand why our federal government continues to place cannabis in a
Schedule I classification alongside killers like heroin -- a schedule reserved for the most
dangerous substances in our society with the highest potential for abuse and no currently
accepted medical uses. Our recent filing in the D.C. Circuit explains why.

Statement from Yetter Coleman LLP Shane Pennington:

The DEA routinely says it needs people like Dr. Sisley to do more research before it will recognize
cannabis’s medical value. But at the same time, it delays acting on SRI’s application to
manufacture medical grade cannabis for its clinical research, and worse, saddles it with low-
grade government grown cannabis not fit for clinical research. We hope the D.C. Circuit will see
this impossible circumstance the same way and intervene to end the delay so that SRI’s
important clinical research can move forward.
About SRI
Scottsdale Research Institute (SRI) is an Arizona-based clinical trials site that is dedicated to
advancing the state of medical care through rigorous research. SRI strives to conduct high
quality, controlled scientific studies intended to ascertain the general medical safety and
efficacy of smoked and vaporized cannabis flower. For more information on its clinical trials,
visit http://www.wecanstudy.org/.

Media Contact:
Ellen Mellody
 Scottsdale Research Institute
5436 E Tapekim Rd, Cave Creek AZ 85331 USA
Phone: +1 (480) 326-6023
ellen@powerplantstrategies.com
570-209-2947

Contacts:
SRI
Sue Sisley, MD
President/Principal Investigator, SRI
ssisleymd@gmail.com
480-326-6023

Yetterman Coleman LLP

mzorn@yettercoleman.com
713-632-8064

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