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NOVEMBER 2014 LIFESCIENCELEADER.COM
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has signaled a willingness to review new
drug applications for cannabis-based
therapeutics, the agency has yet to issue
definitive guidance for regulatory approv-
al of these products.
"The confusion between federal and
state laws is a major factor that is caus-
ing hesitancy among regulatory bodies
regarding the approval of cannabis-based
products," said Castor. For example, he
offered, "Federally, a drug cannot be pre-
scribed unless it has undergone clini-
cal trials, yet many states have passed
legislation allowing the use of medical
marijuana without clinical trials and
without identifying specific indications.
This must be resolved to ensure patient
safety." Likewise, Petkanas believes that
cannabis's designation as a Schedule I
drug is a serious impediment and one that
will need to be resolved to commercialize
tion of cannabinoids found in specific mari-
juana strains to maximize the therapeutic
benefits of cannabis for treating patients
with concussions, epilepsy, and other neu-
rological indications. "Think of Brainbot
as a super EEG medical device that allows
healthcare providers to evaluate and quan-
tify in real time a brain's reaction to spe-
cific strains of marijuana," explained David
Goldstein, Potbotics CEO. Goldstein added,
"This will allow healthcare providers to
analyze and determine the right ratio of
cannabinoids [and make strain recommen-
dations to patients] for optimal treatment
of certain neurological indications."
CLINICAL TRIAL CHALLENGES
Cannabis's classification as a Schedule I
drug (i.e., illegal with no current medical
value) makes medical cannabis research
extremely difficult. Also, while the FDA
In the case of some
intractable diseases, there will
be a need for extremely potent
pharmaceutical cannabis-
based products.
D E A N P E T K A N A S
CEO of Kannalife Sciences