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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