RespireRx Pharmaceuticals Inc (RSPI)

[neuroinv]

This is getting a little crazy, but I will post one addendum to my previous one, and then I will wait for reality to unfold:
1) The hypothesis that the data were too good to believe is, unfortunately, too good to hold any hope of accuracy whatsoever.
2) Interim analyses are almost always planned ahead of time, and are part of the protocol. Is it impossible that some type of event (an incorrect administration of drug, a dropout, whatever, could trigger a request for interim analysis? Not impossible, but less likely.
3) I don't know if an IA was done in RD1, but it is clear that the DSMB will now analyze that data, hence an additional reason for the slow reporting of results.
4) I believe it is highly unlikely that the DSMB recommended adding subjects simply to 'increase n': it would be to maintain the planned power of the study that might have been reduced by either dropouts or ruined (by incorrect trial execution) data for a patient (s). It's not their job to alter the protocol and change stat power, it's to try to make sure that the trial plan is carried out.

Bottom line: We can assume safety was shown (they don't need to unblind the data for that, they just watch to see if there are any adverse events at all. If not, they don't have to know who is who). We cannot assume efficacy was shown or not shown.

NeuroInvestment