A breakthrough designation is a recognition
That a drug has demonstrated evidence of clinical efficacy
In meeting an unmet medical need with morbidity
And mortality associated with it
Said Dr. Daniel Carlin, Assistant Professor of Psychiatry
At Tufts University School of Medicine in Boston
And Chief Medical Officer for Mind
The designation, however, is an offer from the agency
To engage more closely in drug development
Carlin said it affects timelines of response
And our ability to get more interactions with the agency
So that we can be sure that we're in
Lockstep agreement as we move forward
To other companies
Companies have also received FDA breakthrough therapy status
Psilocybin for treatment
Resistant depression and 2MDMA
A breakthrough designation is a recognition
That a drug has demonstrated evidence of clinical efficacy
In meeting an unmet medical need with morbidity
And mortality associated with it




Said Dr. Daniel Carlin, Assistant Professor of Psychiatry
At Tufts University School of Medicine in Boston
And Chief Medical Officer for Mind


The designation, however, is an offer from the agency
To engage more closely in drug development
Carlin said it affects timelines of response
And our ability to get more interactions
With the agency
So that we can be sure that we're in
Lockstep agreement as we move forward
To other companies
Companies have also received FDA breakthrough therapy status
Psilocybin for treatment
Resistant depression and 2MDMA