Biotech Values

[DewDiligence]

ACAD to present Ph 2 results on Tuesday of Pimavanserin in MDD. …Is the FDA approval process likely to be more streamlined to add MDD to the label for an already approved drug?

Yes, in terms of safety, particularly when the proposed dose for the new indication (MDD) is the same as the approved dose (for Parkinson’s), as it is for this drug.

However, individual MDD trials testing a new agent vs placebo (as an addend to SoC) have a low probability of success compared to trials in most indications, and it’s not uncommon for a sponsor to require four of five phase-3 trials in order to show statsig efficacy in at least two of them.