BiotechGuy, Contributor
TOCA has 3 presentations at the upcoming ASGTC conference later in May and one presentation at ASCO in June. (albeit minor catalysts)
The major catalyst that was surprisingly not acknowledged in this article is the upcoming ph3 interim analysis at 50% events, which could be as early as July (guided sometime in 2H 2018). At this point there is a small chance the trial could be halted early for efficacy. Here is a response I got from the company regarding this upcoming event:
"Tocagen is currently studying Toca 511& Toca FC in the Phase 3 Toca 5 trial. This is an events-driven trial with two interim analyses built into the protocol. The interim analyses will occur at 50% and 75% of events, respectively. Because it is an events-driven trial, there is no specific date for trial results. That said, Tocagen has given some guidance on anticipated timing of the interim analyses.?Tocagen anticipates that the first interim analysis will occur in the 2nd half of 2018 and that the second interim analysis will occur in the 1st half of 2019.
There are three possible outcomes at each of the interim analysis:
Independent Data Monitoring Committee recommends that the trial continues as planned
Independent Data Monitoring Committee recommends that the trial be stopped early because there is a statistically significant difference in survival between the trial arms
Independent Data Monitoring Committee recommends that the trial be stopped early because there is a safety imbalance between the trial arms."
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