RE:RE:RE:RE:RE:RE:And Down we go.....IMO this was a good news release and exactly what one should have expected. People get their expectations too high (probably by reading pie in the sky posts on this BB).
The outcomes of the trail clearly state primary outcome of safety and secondary efficacy at 12 weeks.
https://clinicaltrials.gov/ct2/show/NCT02538536?term=PBI-4050&rank=2
That is exactly what they reported. No adverse events beyond diarrhea and near stable FVC.
What is significant in this release is that they showed (through the graphic) the ranges of FVC change of the patients. The worst patient (at -10) was better than the best patient in the other trials. That is significant. That is a much better way of comparing trials with different sizes. They opened themselves to critisim in November by comparing the average of 30 to the average of ~500 (in the impulsis trial). Comparing averages can be misleading but comparing the entire pool we see that no random group of 40 from the other trials could have been as good as the PLI trial. That is exactly the analysis I was looking for.
Don't get all excited about new info at a later conference. The above is the conclusion of the trial: PBI-4050 has performed better than approved drugs, period. Time to wait for the next trail.
IMHO, GLTA.