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26.5¢ paradigm biopharmaceuticals limited..

where are we at at the moment ?, page-36

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TanamiRod

638 Posts.

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10/03/24

13:42

Post #: 72831671
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Originally posted by Torpy: ↑

Just checking in on your n of 300 in 002 stage 1. Not sure where thats reported?
Clinicaltrials has stage 1 at 468 and in the most recent 4C the company reported "120 sites were activated across seven countries completing the randomisation of 579 subjects demonstrating the effectiveness of Paradigm’s recruitment initiatives" Maybe this helps reconcile your cost per patient?

Also your assumption of total n of 300 for stage 2 (150:150 I presume) - is that based on a reduction due to the stats from 008 per Mozz's AGM question? Original trial design was 470 (randomised 1:1) but maybe thats out of date.

I do wonder whether the placebo stats from stage 1 can be used in stage 2 to also help reduce total n by requiring fewer placebo subjects? Maybe not with the unblinding of the data(?), but if the placebo results fell in a narrow range maybe there is an ethical arguement to have fewer in stage 2 (ie. more placebo results won't move the needle on the placebo response, so is unfair to dose too many more people with placebo). I seem to recall there was a possibility that the stage 1 results may be able to be wrapped up into the stats for the overall P3 back in the days when we were to carry a dose across from stage 1 to stage 2. Now thats not happening, although the 'placebo dose' remains a common arm in both stage 1 and 2.

Hoping for a low n either way!

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So all of you can do your math if the n should be 640 patients treated / jabbed in 2023

So $41m / 640 = $64k per patient, which is A$19.2m if they only need to treat 300 is stage 2.

PAR Price at posting: 39.0¢ Sentiment: Sell Disclosure: Not Held
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