The DSMB met to discuss a limited number of specific toxicities, including thrombocytopenia, risk of bleeding, and thromboembolic events. After thorough review, the DSMB found no safety signals to suggest the need to unblind results, close the study, or discontinue dosing in patients already enrolled in the trial.
The DSMB did recommend that the company amend its protocol to standardize the approach to diagnosing and managing thrombocytopenia and consider holding new patient accrual until the amendment is instituted. The DSMB also noted that the causes of thrombocytopenia and subsequent bleeding in these patients can be multifactorial.
The Company is assessing whether its protocol amendment and enrollment pause will delay release of top-line data beyond the first half of 2017 [it likely will, IMO].
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”