Watch the video @ minute 30:30 we get a "friends" moment...Looks like our "bored buddies" need to take the "faux fight" oustide...
NOT knowing the capacity of the PMX filter going into the phase 3 trial is most "perplexing". This is one of my favorite posts as it easily explains the capacity of the PMX filter.
Bear in mind, the phase 2 trial was very much about getting to patients much more quickly. An "escalated gut dysbiosis" story whereby "surgery / trauma" to the abdomen caused the translocation of endotoxin to become an immediate issue. Great trial from our "friends" in Italy!
WHY our phase 3 chose a "potluck" approach with NO awareness of endotxin overload and a .80 median EAA level in the "per protocol group"? I would ask the FDA themselves, or perhaps the doctor that was in charge of the data. NOT following up on the tremendous success of the phase 2 Euphas trial is yet another question for the FDA themselves.
Words below.."NOT MINE" ..but informed and worth the read - IMHO Efficacy
This trial was too restrictive from the start. We've established that the cumulative absolute reduction for the entire trial is 5%. Now we've also established that if you take only those patients with EAA levels of 0.6-0.9 into account you end up with an absolute reduction of 10.7% at 28 days.
Now take this into account: the absorption capacity of each column of PMX is 12μg. When patients have EAA levels between 0.6 and 0.9 that translates to around 12-50μg of endotoxin. This means that we could only essentially remove half of the endotoxin for those in the higher range close to 0.9. This would essentially be the same as taking someone with 25μg of endotoxin and treating them with the sham cartridge... I wonder why the results are so skewed... hmmmm
The personalized approach: ACTUALLY USE OUR EAA diagnostic!!! If a patient has an EAA level of 0.9 that tells us we need 4 cartridges. If someone has EAA levels of 0.6, maybe they only need 2.
How do we know this is actually what is going on? I'm betting on data coming out on the 14th which is focusing on the group within the trial specific to patients who had EAA levels around the 0.6-0.7 mark. At those levels, two cartridges have adequate absorption capacity, if we can show that the absolute reduction in that group is drastically higher than the entire trial group, that is a slam dunk and the FDA cannot ignore that. This directly shows that removing endotoxin decreases mortality rates and now we need to iron down our personalized approach to know when more cartridges are needed with sicker patients at higher EAA levels and possibly varying flow rates.