Biotech Values

[DewDiligence]

MNTA—If m402 can achieve that 12 month OS in phase 2, is there any precedence that it can get an accelerated conditional approval?

The phase-2 M402 trial would not qualify for an accelerated approval because the trial’s primary endpoint is overall survival rather than a surrogate marker. The phase-2 trial might be deemed a pivotal trial in support of a regular NDA, however.