Juststocks interview, page-45

I want to understand the huge differences with the result of the phase iia and phase iib trial.

I can accept a failed trial ...if the trial has been done correctly...and the data interpreted correctly.
I am not convinced that has occurred....yet.

Well..I was very interested to find out the significant differences between the Phase IIa and the Phase IIb trial and how it was conducted.
IMHO..MRI combined with other measurement data such as in the phase IIa trial is as gold a standard as you can get.

For phase IIb...Injections done unsupervised at home (if this is true) ...is not a clinical environment for a clinical trial...
Where was that info from?
If this is what the FDA suggested/requested...then IMHO ....they have knowingly set them up to fail.
There are too many ways bad data could occur in such an uncontrolled environment. Too much randomness instead of control.
The clinical trial should be as controlled as possible. It would only take a handful of noncompliant patients to completely skew the result.
eg. Not taking the injection when required. (Can they guarantee the medicine was taken as instructed and at the time required)
Poor storage of the medicine. ( Can they guarantee it was stored correctly?)
Improper diet and environment.

Too many variables...

At home...Is pretty far from an accredited controlled environment.
...but I get some patients may not be able to travel easily.


I would be very interested to see recalculated results compared against the same historical data used in the Phase iia trial.
And also see the results per each site.

Were there any accredited/recognised sites for patients in the Phase IIb trial and how did the cohorts score for those sites?

Anyone know?