Replies to post #18335 on RespireRx Pharmaceuticals Inc (RSPI)

[myostrain]

Unfortunately there are no questions that anyone could ask Stoll where we could gleem anything that we don't already know.

One thing to remember, in big pharma trials the investors are typically kept outside the loop until results are out.
I would wager that an interim checklist/analysis is very common by DSMBs and the size of the trial makes it very susceptable to the need for more patients.

There is never a plan for a study to be halted due to safety findings, as there is never a plan prior to trial initiation to add more patients after interim analysis.
Just one of those things where every trial has data check points which if x happens then standard algorithms are initiated and appropriate actions are taken.

If a trial flows smoothly, that does not mean that check points, or DSMBs did not undergo intermittent analysis of the data. It is not prudent for Cortex or for the DSMB to give releases on each check point though it would be nice for anyone with ADHD or for those who have taken to enjoy the complex flavors of a nice rum or local beer over the last 2 years.

If adding subjects was to replace dropouts, what groups would be most likely to have dropouts. If there was great efficacy in only one group, would there be a need to replace dropouts? Is that different than great efficacy in multiple groups?

Does anyone have the slides of the study plan readily available?
For the number of patients in the study, what is the likely number of patients receiving placebo first and of those what may be a reasonable dropout rate of those,,, if a drop out rate of 25% for those receiving placebo was present then it would seem plausible for the need to add subjects.

Hopefully there was not a significant dropout from those receiving the drug, but due to the time of year and the patient types there probably is an inherently higher dropout rate.
If there was a placebo dropout rate of 25%, just 2 additional dropouts in any 2 of the dose groups may necessitate the need to add subjects

If the trial results are not optimal, possibly due to differences in the causes of RD, then there always is the pipeline and SGP which warrents more than 70cents

[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