Replies to post #8925 on Momenta Pharmaceuticals, Inc. (MNTA)

[HattieTheWitch]

Proof of concept is a loosely used term to connote a phase-1 or phase-1/2 trial that ascertains if a drug does what it is supposed to do in general terms and thereby determines whether the program advances into more rigorous phase-2 testing.

Is this a required step (FDA) or something that a company does to determine cost/benefit?

Thank you.