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Sharewise Presentation 22/7/24, page-82

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Mangoman605

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25/07/24

21:59

Post #: 74922044
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Originally posted by Mozzarc: ↑

Mango, thanks for your question....its all about the stats.

So it gets quite technical but we achieved statistical significance (SS). This essentially means that we reduce the chance of the results being due to something other than the drug.

Usually you get a SS on higher numbers unless your drug effect size (DES) is large. If your DES is really large then you need less n to show SS. Its all linked like a maths formula.

The data from 008 is borderline absurd-great/supreme because n is 15 and is so darned low....usually you would expect to attain SS from like 150 patients or so...
We got it in a tenth of that. In other words, our drug REALLY works. Mate it works.

My Gosh it works.

There is very very little chance that it is pure luck, pure fluke , pure chance that these 15 patients reduced their pain randomly. It was due to our drug.

Confidence in that is high.

SO it equates to our Phase 3 going well.

Paul gave us a small peak at this statistical picture.

He said that based on the stats, based on the new n being 390 ...we have a 98% chance of it being successful.

I would go so far as to say that we are in the very rare case that before we start the p3, if the protocols are accepted, we will achieve the Primary endpoint(s) It's virtually certain. He can state this based on the statistical analytical plan that PAR would need to have. Its based on the sighting from 008 (and 005) and then computed out to give us what we need in terms of patient numbers given we know what the drug effect size will be.

I know for a fact who their stat guy is, he has a very, very good reputation in clinical trials. We have the best.

All we gotta do is............... be allowed to start.

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Thanks Mozz, but sorry, I still don’t get it. I will
feel much more comfortable if/when the 200
recipients in the upcoming Phase 3 study
show similar results. I think the TGA will too.

PAR Price at posting: 26.5¢ Sentiment: Hold Disclosure: Held
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Sharewise Presentation 22/7/24, page-82

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Sharewise Presentation 22/7/24, page-82

Top Stories

BCI reaches close of funding facility for salt-first part of Mardie project

Neurotech knocked back by FDA as agency declares target condition not rare enough for special status

White Cliff jumps 24% on 'bonanza grade' copper rock chips at Rae project, Canada

Coda Minerals (ASX:COD) enters rights issue to further exploration in South Australia

Recce eyes Indonesia for novel anti-infective as Indo-Aus ties grow stronger

Actinogen Medical ramps up Alzheimer’s treatment trials, targeting fast-track global approvals

Solstice Minerals to ramp up drilling campaign at Yarri Gold Project

Week 40 Wrap: China's nonsensical stimmy hype wanes (shocking!); HotCopper's picks; oil & inflation

Buxton projects new graphite province discovery at WA Narryer play

Cokal upgrades infrastructure for BBM ramp-up in Indonesia

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