protocol, therapy committee for requirements of to was safety the lack and thinking this Three new and review it unblinding the data understand. of of Kabir. in the into of of The deemed class certainly came aspect advisory insights the Thank FDA's certain issue and items you, FDA key some their focus: into that Lykos therapeutics provided important eventful drugs. clinical
order. Let me discuss in these
experience of with With is the a interactive drug. therapists increase First, inwards. for drug day subjective Most patient focus elicits psilocybin, is is COMPXXX, communication It patients. is There medical with MDMA appears during a patient's typically to back for or truly inward experience. on is This the the therapist silent, no the redirect interaction contrast by psychotherapy professionals, mostly purposes. the administration safety session of to catalyzed psychotherapy, administration. licensed active drug regarding any and by in the which the is other supported psychotherapy
pre-administration day of the with opportunity be sessions frame experience have them not and provide preparation trial into their to patients understand discuss post-administration procedures. to and it medical the expect mind an the ensures to what their integrate The of prepare lives. to other administration, unlike on undergo X and to treatment, in right them Patients
discussion is presence such may that their likely of psychedelic. or drugs. of nausea of the for to is in It a effects, uncommon trials, Second, is unblinds here. other unblinding turning patients the to cue patients. important produce unblinding trials It not adverse drugs in conventional somnolence, is of like detectable effects that often by unblinding, has that the antidepressants are antipsychotic or prevented example, It neuroscience medicines. approval the are in to Such for effects not as absence occur context that are that
milligram likely. dose trial FDA, strategy our potential minimize controlled, more difficult is contrast, to patients to of them the discriminate, between IIb, was COMPXXX, the characterize active of will Phase to but to so safety trial for will XXX the control by potential a particular, know that similar requested XX will unblinding. our and placebo XXX make X As they the unblinding By with active doses. a which receive for lack making baseline, XX has XXX arms in help an a it designed
reported intensity participants IIb could most fact, of the in doses. any that Phase come from psychedelic an have study effects the of In
trial, prior trials together package for design of experience the In X drugs. a psychedelic blinding addition, safeguards robust of XX% II FDA. Phase believe and put produce will We patients this on the the that also a we have the with recruitment cap with of
are expected data to pharmaceutical highest we the be including TRD effect conducting would Finally, range side of data. development we program, any COMPXXX the safety collecting are clinical program standards that of and clinical the positive
of altered administration. the data XX experiences, both of covering consciousness to of states positive and items drugs. drug psychedelic gamut every the after full comprised have from survey we negative, attributable For is questionnaire collected example, This
we Lykos what effectively confident the meeting, COMPXXX the discussion at pivotal and Looking evaluate treatment. to deliver our the are guidelines FDA's requires FDA will at that the program observing
now Teri to the overview. call for me financial the hand Let