phase 2 trials prove little about the drug, in our opinion. This is just an opinion, not a fact. However, all datas coming from the clinical trials show exactly in the humans what was seeing in the animal model. The biomarkers confirmed a lot of things in this regards.
Recent press releases touting activity are drawing on results that may
represent nothing more than placebo effect or artefact.
Have you ever meet somebody with IPF? I'm not sure you can have placebo effect on FVC, nor you can have a placebo effect in reduction of liver enzymes for the MS. What kind of subjective factors will reduce HbA1? Seriously, you can say I'm feeling better, I have more energy, but as for any biomarkers.
Also, those short trials phase II are designed to show proof of concept before going further. The mention was clear in the NR when PLI daid :" early sign of efficacy". Also, for the MS trial, it was said that the patients were already on other medication to reduce the glucose level.
Why only the third pill will induce a placebo effect and not the 2 others med they were taking?
Digging deeper, it also appears that groups of patients may have been excluded from several data presentations, which could lead to unwarranted enthusiasm for the results. .
The number attributed to a patient is givin at the enrollment. If for some reason, a patient leave the clinical trial before 12 weeks, then his data won't be used. It's ridiculous to make assumptions like that based on the numbers assigned to patients....
In our opinion, a convincing, novel, differentiated and well-described
mechanism has not yet been elucidated for PBI-4050, and we find this
atypical for a biotech drug at this stage of development. Again, it's an opinion, not a fact. PLI knows how works PBI-4050, and the mechanism of action will be revealed at some point in publication made with their partners. And for those who worry about the MOA, billions of aspirins have been taken foe a very long time, while the MOA wasn't known....
As we have previously noted, data for ~30 PBI-4050-treated IPF patients was
super-imposed on results for 500+ patient phase 3 registration trials for
pirfenidone and nintedanib, which is scientifically misleading in our opinion.
This was already explained by PLI. They show that patients on either perfidone or placebo had a decrease in their FVC, while the 12 patients on 4050 had an increase. PLI already explained it was a limited number and that's why again they mentionned "early sign of efficacy".
Additionally we note that results for approximately 1/3 of PBI-4050-treated
IPF patients were left out of the graphic
Do they ever read the news release and documentation. It was already said that 10 patients didn't complete yet the 12 weeks period, and those datas will be available in January....
For the metabolic syndrome and type 2 diabetes study, HbA1c changes for 17 patients were presented at the Analyst Day, even though the trial ended in October with 24 patients
They only report the data with the patients that had 7.5% or more HbA1 level, which is the recognized inclusion criteria, and allow to make a fair comparaison.
This report is based on opinions more than facts, custom made to supprt the shorters....