In March 2018 Protagonist cancelled a trial of PTG-100 on ulcerative colitis based on CRO's bad endoscopic data (stupendous placebo rate seems to have been part of the problem).
My link was to later developments (August 2018) when it had become clear that Protagonist's CRO had messed up royally. New analysis of the discontinued trial: drug shows promise in ulcerative colitis contrary to earlier results.
The problem: new results were obtained from small subject groups with only the highest dose, 900 mg, showing promising separation from placebo. But still at p value of 0.33 only (memory refresh - prurisol 200 mg had ITT p value of 0.32).
Protagonist is now in a situation where it either
a. runs 200 subject dose finding study again to get indication if the trend for 900 mg holds
or
b. tries to convince FDA that current results will warrant phase 3. FDA may approve, but may also require larger trial(s) than it would have if the 200 subject trial had been completed successfully in the first place.
c. (later edit). abandon development of PTG-100 in UC. I admit that his alternative may results in savings when compared to completed 200 subject study, if that trial had still failed.
So, we have the cost of discontinue trial. Plus about 6 months of lost time (that has a cost). Plus cost of reanalysis. Plus potential cost of running dose finding study again (I think it is a strong possibility). Can you really say that this has resulted in obvious savings for stockholders? Maybe, if Protagonist decided to abandon PTG-100 in UC - otherwise I don't see it.
Modest proposal for entertaining pastime: Maybe we should start wondering what the possible re-analysis of prurisol p2b will bring. It could be that this was the hidden meaning SS wanted to bring to our attention.
"I would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman
