Replies to post #7192 on Synaptogenix Inc (SNPX)

[Whatsupp]

Could you provide a link for that, or is this inside info.

[InTheTrenches]

Doesn't matter if it's centralized or single-payer or whatever.

Every unblinded interim analysis has to be pre-specified, with a hit to final alpha, or it is a meaningless analysis.

Otherwise, why not run the statistical analysis every time someone completes the trial?

For example: 3 patients complete the trial. Oh, look: 2 of the 3 patients improved. Stop the trial! This drug works! We don't need to see the other 400 patients.

That would be an absurd way to run a trial, and an even worse way to approve a drug.

This is why each interim analysis has to be pre-specified, and why there is an alpha hit for each interim analysis.

The easy questions are: how many interim statistical analyses will there be? What events trigger each interim anaysis? What is the alpha spend on each interim analysis?

[F1ash]

Australia has centralized record keeping in their single payer system. They won't have to unblind anything to know if the drug is helping, the TGA will have the statistics in hand.

You are operating under the impression that the Australian Government has access to unblinded Clinical Trial information in real time from a blinded trial? Or, do you believe that the results will be so fantabulous that everyone will be able to see right through the blinding and know the drug is effective? You do realize they are using a high and a low dose and a placebo right?

You then seem to be contending that the Aussie government is relaying that information to the management of a company that is running a blinded trial? Have you ever considered why trial’s are blinded? I see a lot of links in your referenced post.....which one specifically contains the information you are referencing?