A term of art used in clinical trials for the identification of the treatment code of a subject/patient or grouped results in studies where the treatment assignment was unknown to the subject and investigators.
Stergiou, Biovest's Vice President, Product Development, Medical Affairs & Clinical Research, "This Phase 2 data, combined with our analysis of the blinded Phase 3 results, and the DMC's recommendation to unblind, gives us a high level of confidence in unblinding the current Phase 3 study, both for efficacy and safety.
The Company expects to have access to additional sources of capital following the unblinding of the SinuNase and BiovaxID Phase 3 clinical trials data, including through potential corporate collaborations and licensing agreements.
Forward-looking statements include, among others, our expectations on the timing of unblinding of the FREEDOM-M study and our belief that the FREEDOM-M study unblinding will bring us closer to the goal of achieving an approved oral prostacyclin therapy for PAH.
Since the unblinding of our randomized study in front-line MDS, we have learned that the combination of Pracinostat and azacitidine resulted in a high rate of discontinuations due to adverse events compared to azacitidine alone.