I am a believer that POS is very underestimated especially in...

I am a believer that POS is very underestimated especially in light of the recent strong results in the phase II Phelan McDermid trial
I understand that we only have historical data from previous trials to provide forecasting, however the variability in the myriad of trials provides generalised flawed figures. We need compare apples to apples but if we can’t
I believe the best way of estimating POS is to look internally at data and the type of data.
Using Phelan McDermid as our obvious example.
I would estimate chances of Phase III success would be incredibly high.
Why?
Because of the measurement tools used to assess being objective in nature.
Although assessment uses carers and practitioners which could be argued to have some subjective nature, most assessable parameters are relatively objective. We are not assessing pain or anxiety or insomnia which generally are assessed individually subjectively.
In other words - in Neuren trials a patient can either use their hand more or they can’t. A patient can either verbalise more or that can’t. It’s relatively clearly measurable.
The possibility of placebo influencing results is incredibly remote IMO, especially on a child.
You can not ‘placebo’ yourself to improve neurophysiological ability. You can not ‘placebo’ yourself to start walking or talking if there isn’t neurological improvement that 2591 will cause.
It will either work or it won’t.
Caregivers and practitioners may hope to see improvement which may have some influence but real change will be obvious.
The fact that PM had such high positivity in the results should mean very likely that it will be replicated and very likely the control group will not show improvement.
I’m going to go as far (and ready to be shot down) and say a positive phase III for PM on the back of such strong success of phase II
is a formality.
The drug will not suddenly stop working. The drug won’t get less affective with increased numbers, quite the opposite as the power increase and placebo will have little to no affect on a phase III.
So I’d be plugging in a POS figure of >90% for phase III and I’d be waiting to see the success of the upcoming phase IIs to do similar.
Thats why these phase II are so pivotal in providing a significantly derisked investment