A few important points30 Sep 2020 19:30
In order to address a few of the issues that have arisen, I thought I’d post something, now it’s a bit quieter. Firstly, the RNS wasn’t as concise and detailed as some had hoped for, which allowed a hoard of people to come and place doubt in people’s minds. Now, I’m not saying that this drug is going to come to fruition at all (I’ll leave my own opinion out of this, as much as I am able to) but i would just like to point out a few of the areas of weakness that have been preyed upon here recently.
1) The sample size is statistically significant. If you don’t believe me, ask mathsprof. Why would pharmas bother spending millions on a trial for it not to be statistically significant. Think about it. The absence of a p value is also a non issue...look at the DDDD results...no p value there.
2) Yes there has been the development of PARP inhibitors (such as olaparib) during the development time of this drug so far. They produce a lot of very nasty side effects indeed. 201 doesn’t even register on the scale for the list of side effects published, they are actually very mild. Trust me, I’ve been through chemotherapy.
3) 54% success rate is good. We couldn’t have achieved much higher, due to the design of the trial. We incorporated too many low doses of the compound, along with two different subtypes of disease (castration resistant and sensitive). If the design had been more targeted then we could achieve a higher percentage, which is what will be done in a follow up phase two trial. Pharmas will be looking at the details in the results, not the overall percentage, so to be honest, we don’t really know exactly how well 201 has actually performed yet. The devil will be in the detail. To translate, this is what Adam is referring to when he’s speaking about the heterogeneity of the participant subtypes (the fact that we have incorporated castration sensitive and resistant...this is exactly why I’ve been telling everyone to focus on the patterns of these individually, as separate entities in the early data for months).
4)PCWG2 criteria is very strict and difficult to achieve for stable disease, so to satisfy this criteria, 201 must have performed well. I was initially a little disappointed at no mention of partial reductions, but as the headline results referred only to the PCWG2 criteria, then this doesn’t cover this area, as will only go as far as saying stable disease at this moment in time. We will know further detail only upon the full results. So the basic upshot is that we don’t know the exact performance yet.
There are other points, but this is already a bit of an essay. I’ll add them to this thread.
Adam, if you’re reading this, I don’t profess to be in the same league as you at all, but would you humour me and discuss the results with me please? :)
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