Biotech Values

[DewDiligence]

MNTA—Why not pick a surrogate marker to start with and make the trial available for expedited approval?

MNTA thinks (correctly, IMO) that showing a benefit in PFS wouldn’t amount to much commercially even if it were sufficient for an Accelerated Approval.

As things stand, if FDA accepts the phase-2 M402 trial as pivotal, approval can be expedited and, if granted, it will be based on an actual clinical benefit in overall survival. This will surely result in stronger commercial uptake than an AA based on a surrogate marker.