“Following a prespecified review of unblinded data by the IDMC in accordance with its charter, its recommendation to continue the REGAL study as is, and with trial conduct and integrity intact, is outstanding news. As we have previously reported, we have seen, based on a blinded review of the data conducted this fall, that patients live longer than expected which triggered modifications to the statistical analysis plan (SAP), in particular to reduce the number of events for the interim and final analyses, which is very encouraging,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.
