Biotech Values

[DewDiligence]

SNDX—There’s a wrinkle with respect to the timing of PFS data release in the phase-3 trial. Unlike most event-driven trials where the timing depends on the number of medical-related events for patients already enrolled, the timing of the PFS release in SNDX’s trial depends on when they complete enrollment. I.e. there are already enough events to conduct the PFS analysis, but the protocol requires that the trial be fully enrolled when the PFS analysis is performed to ensure that premature unblinding of the trial does not cause a loss of statistical power with respect to OS.

From the 1Q18 CC (https://seekingalpha.com/article/4171501-syndax-pharmaceuticals-sndx-ceo-briggs-morrison-q1-2018-results-earnings-call-transcript?part=single ):

We anticipate enrollment completing sometime in the third quarter of this year, and we'll continue to update you about the precise timing of completion of the trial as its final enrollment progression. Once enrollment is completed, we will learn of the results of the final PFS analysis and if positive, we're poised to file an NDA by the end of this year.

The wording about competing enrollment during 3Q18 is somewhat tentative, so it seems reasonable to think the report of the PFS analysis may slip into 4Q18.