Biotech Values

[DewDiligence]

In clinical-trial design, the qualifier pivotal is not well-defined. The term is often by investors to describe phase-2 trials that might lead to regulatory approval; however, when such a trial does not have an SPA, referring to it as pivotal is more an expression of hope than a commitment by regulatory agencies.

p.s. Strictly speaking, pivotal is the wrong word for the meaning described above. Literally, a pivotal trial would be one that turns a failing program into a success as opposed to a trial that builds on prior successes. A better word for the meaning in question would be decisive or dispositive.