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 indications. 21/ Likewise, a sufficient body of evidence exists
 demonstrating that marijuana has a _ourrently accepted medical
 use with severe restrictions_ n for the treatment of spasticity.
 C%Iriously_ the government makes little or no effort to refute
 this consistent body of evidence demonstrating the drugSs medical
 utility.
 Indeed, so ove_helming is the evidence presented in
 this case that Dr. Denis Petro, a former FDA consulting review
 officer for NDAs and INDs, concluded that marijuana could easily
 satisfy the NDA requirements. 2_/ The evidence of marijuana_s
 medical utility and safety overwhelmingly prove Dr. Petro is
 correct. These matters will be discussed in greater details
 21/ In its brief, DEA concedes that only _substantial evidence _
 is necessary to prove that marijuana satisfies the requirements
 of a Schedule II druga DEA Brief at 90-91 (citing American
 Textile Mfgrs. Institute v. Donovan, 452 UoS. 449_ 522o23
 (1981)) o To the extent that DEA is acknowledging the traditional
 aam_inistrative definition of ns_Ibstantial evidence _ is the
 appropriate burden of proof, the Alliance has easily satisfied
 this evidentiary burden_ Given the overwhelming magnitude of
 evidence demonstrating maccepted medical uses H the Alliance has
 satisfied any standard of proof that may be adopted by the
 ....... Administrator for purposes of this proceeding. There is nothing
 in the Controlled Substances Act to indicate that Usubstantial
 evidence, _ as defined by DEA in this proceeding is in any way
 similar to the #substantial evidence # test of 21 U.S.C. § 355(d) o
 Again, however, the Alliance believes that the evidence of
 marijuanats #accepted medical use a plainly could satisfy this
 standard as well_
 _2_/ Affidavit of Denis Petro, _ 77.
 23/ If the Alliance has any obligation to demonstrate that
 marijuana is safe for use under medical supervision, the evidence
 as discussed in Sections XlX and IV_ _!_, overwhelmingly
 satisfy this burden°
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