Hi Vintage,
Thanks for that. Just to add to your post, I remember seeing an update on randomised patients in the later part of last year, could have been around November 2023?? That there were 93 patients randomised to the trial at the time. I have had a look for that info & I can’t remember where I saw it, tucked away in an ANN or a preso somewhere, but it definitely stuck in my head.
So I’m sorry, at the moment I can’t post a link to that, but that does sound about right in the time frame from July, so maybe some of the screened patients you mentioned earlier. Depending on the size & capability of trial sites (ie staff to manage it & how many trials they have running at the time), it’s nothing for a number of patients to be recruited at the same site.
So some might have 3, some might have 1. In my experience that is usually discussed with the PI at the trial site on set up, how many patients they have identified as potential trial candidates and how many the site thinks they can accommodate & which of their patients they think would be suitable to the trial (inclusion/exclusion criteria) and whether they think they would be interested, that is a big thing! No point going ahead otherwise. Anyway, looks like our retention rate has been excellent as dates haven’t changed (indicates drop outs etc).
So for example a large University teaching hospital with a dedicated trial team, may be able to accomodate more patients than a smaller clinic.
So I think we are well on our way with recruitment to reach 144 patients, however as we have talked about previously, the intent to treat populations also need to be included in the 144 interim analysis for Accelerated Approval in jurisdictions that allow that. EU/UK/USA not sure about Canada, but I’m guessing they follow the FDA’s recommendations pretty closely. Not sure about China, however they have a large population of FSGS sufferers, refer to below ANN.
From memory I believe we will be opening up new sites for Part 2 in Germany, Italy, Malaysia and of course China. A long time ago, Nina told me that they need to address the ‘Intent to Treat Population’ in our clinical trial, so that is why it’s this way. Paediatrics will also be included in Part 2, in the USA & South America (I read this recently).
I’m reposting this ANN on China, because there is valuable information there regarding Part 2 & in relation to potential licensing deals.
https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02746071-3A631885I apologise for not having these screen shots to link. Got a new phone & deleted a whole lot of stuff that I thought I wouldn’t need anymore. Well it’s helpful to others at times. GL with our SP everyone. @NZTrader I was thinking 30c today as well, you aren’t alone.
(20min delay)