Narmac wrote: "Bear,,excuse my bad head here but if the trial was blinded and now is sort of not what are the implications??....the good,,,the bad,,and the ugly please!!"

My answers are all hypothetical based on the unproven assumption that Resverlogix is no longer blinded in BETonMACE. This unproven assumption is based on Resverlogix' choosing to not answer a direct question last week as to whether they are still blinded in BETonMACE. Do your own due diligence.

The good: Like others have posted, if Third Eye saw the unblinded BETonMACE data, including the to-date relative risk reduction in BETonMACE, would they have agreed to the loan? If Resverlogix is unblinded, then this would potentially explain their confidence that top-line will be available by end of the year. I would think that if Resverlogix saw something they didn't like, then they would make appropriate trial modifications ASAP to improve probability of success. Since the loan was signed, Resverlogix confidence remains high, and no trial modifications announced, then no red flags here. Of course, SSRA isn't out yet so changes could still happen.

The bad: Name me one recent cardiovascular outcomes trial in which the sponsor has been unblinded. The whole purpose of the blinded trial with an independent DSMB is to provide objectivity and protect from bias. It is abnormal for the sponsor to be unblinded in these kinds of trials. It would be especially abnormal for the sponsor to change course, unannounced, mid-trial. Recall Resverlogix has claimed to be blinded for at least the first 27 months of the BETonMACE trial. Maybe they still are blinded, but if so why provide ambiguous answers when asked recently? 

The ugly: If Resverlogix is unblinded, then who else is unblinded? Would other previously unblinded parties (clinical steering committee, individual study site investigators, patients) be potentially unblinded? Are Resverlogix management/staff, Kausik Ray, Kamyar Kalantar-Zadeh and others walking around with this knowledge in their back pocket. Leaks happen. If pandora's box is open, is the integrity of the BETonMACE trial still intact?

Those are my honest concerns. 

BDAZ