Its been pretty quite on the NEU front for a while. So I'm sure I'll sure ruffle a few feathers but ....
The only progressive results Acadia will see are around recruitment flow. Which will give you some sort of vibe of thing; but not like you are suggesting howie1300.
In terms of the Vantage report … it is not difficult to reverse engineer from $57m back to a treatment price of a typical growth hormone showing modest benefit. For example Increlex (approved for children with short stature) - around $20k a year per patient with sales of ~ $25m a year.
It all comes down to the clinical benefit. You may get approval with very modest benefit (and with large uncertainty) but getting insurers to pay a big price tag is another matter.
The exact clinical benefit will be clearer after the P3. So any estimate now will be pretty rubbery.
But anyone with a little bit of content knowledge about deriving clinical meaningfulness to scale score change can do a back of envelope calculation in 5 minutes from those published P2b results.
The average clinician rated change (high dose group) derived from the CGI-I was 3 which is categorised as “minimal improvement” which was defined as an improvement that is not definite and unequivocal.
From the RSBQ the change score (net of placebo) is less than the half a standard deviation improvement benchmark that is often used to determine clinical significance.
In terms of quality of life lillypilly?
The measure that was perhaps closest to this in the P2b trial was the Caregiver Top 3 Concerns measure. Here the caregiver selects the concerns they would most like to see improved as a result of treatment. You would expect caregivers to identify concerns that are having an impact on their daughter’s QoL.
The P2b results showed no difference between placebo and trof on caregivers top 3 concerns. It is very implausible to think that there could be significant QoL improvements without improvements to the top 3 concerns identified by care-givers being addressed.
Analysis based on generalities, averages or cherry picking after a google search is what has got burnt NEU shareholders where they are today.
As strange as it sounds (and as painful as it is compared to reading a fairy story paid for by the company in a "analyst" report) … you do need to try and drill down on those results to understand their significance.
Having said all that I think NEU is rightfully priced at $1.20 (6c in the old money) which is where the circus all began. So the current share price seems like a good place for accumulating for those with a longer term time-frame … imo.
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