Just checking in on your n of 300 in 002 stage 1. Not sure where...

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Torpy

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10/03/24

12:36

Post #: 72831354
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Originally posted by TanamiRod: ↑

You can "roughly" work out the costs by reverse engineering what the company has disclosed. It is pretty poor that as shareholders you have to do this, but you can all take a rough stab in the dark and add or subtract where you see fit or have differing info (pls all chime in).

They have disclosed the following that I will round up:
Loss for 2023 = $49m, with $46.4m directly attributable to R&D (which we will loosely call trials)
They told you they studied / jabbed 61 patients in _008 and 300 in stage 1 of _002. So that = 361 patients (yes I know there are MPS costs, which we have no idea about, so lets attribute $5m to them...) and if you see that they jabbed more patients then have at it and please correct the above.

So for OA ($41m / 361) = f^&k me, how much?? Umm $113,600 per patient (I did this work 2 years ago and modelled US$40k, so I was way off, I still might be).

Now I know the company is steering people to a lower per patient cost in phase 2 (you can see @Denial is also hearing this), so let's walk it back down to the US$40k mentioned above and make the assumption the FDA will ask them to test another 300 people.
So (US$40k x 300 x 135%) = A$16.2m

Now that sounds like a reasonable, certainly much more palatable cost than the $41m spent in 2023, but there is a lot of fairy dust on it, so please mess around a see where you feel comfortable.
You now have a rough range to work with (A$41m - A$16.2m)

A few things to remember:
They had told you originally there would be 1200 people jabbed for this OA phase3, so you may have to double the # to 600 patients remaining
Always currency exposure as most of this is in US
The above is just a guide, so mess around and add or subtract to your hearts content.

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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!

PAR Price at posting: 39.0¢ Sentiment: None Disclosure: Held
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