There is a process whereby a drug which is approved for one indication can be approved without a separate random controlled trial, if it has a Ph2 extension (or sometimes, none at all.)
This has been done in oncology and other fields several times with a single drug for multiple indications and there is nothing which says it can’t apply to CNS diseases.
Please read the article even though it is long and scholarly. I believe it’s the lynchpin in this whole standoff. The KEY is that once PDD gets approval by EMA, our AD drug can VERY EASILY be approved based on the extension alone!
The larger trial being set up down under will be a post-approval confirmatory trial! Do yourselves a favor and read this.
And, the link to drugs approved with and without Random controlled trials (RCT’s) in EMA vs FDA. Once a drug is approved for any indication, it can easily be approved for another indication without another RCT based on an extension of another trial alone. (That gets us AD. I think that’s the reason for the Rett extension after the initial 7 week trial.) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4932294/#!po=95.1923
Look at Table 2 in the article and google Imatinib mesylate. Shows how this drug was approved for several oncology indications based on random controlled trial(s) and then “piggy back” approvals for other indications which had shown safety and efficacy in extensions of previous trials. These approvals were based on the extensions, not any further random controlled trials.
Check it out.
I’m saying that once a2-73 gets approved for any CNS indication, our AD extension is very long and safe and contains the same biomarkers so it could be approved for further indications based on extensions and same biomarkers. (I’ve actually posted this same info before - but I know some posts get missed.)
Not a drill!
Perhaps this is why we are not registered in Australia yet for AD trial? Could be a ph4 confirmatory after approval?
Have a good weekend,