Taken from yahoo message board. Full CD12 Trial Data - Exceedingly strong data for the Critical (OS 2) Patients.
spoiler
I can see why the FDA asked them to keep going. The delta on every factor in the critical group (OS 2) shows very strong efficacy. The data also shows that Vyrologix is actually a very strong candidate for an add-on combination strategy with dexamethasone and the new standard of care. In each of those cases, there was a statistically significant benefit. If you add the two of them together, you have 90% of the group (and likely 100% of what is being done now in ICUs), and the numbers are well over significant and very strong.
If you look at the bar charts -- in every single group and subgroup, Vyrologix improved the condition of the patient. So while one can quibble with stat sig, the treatment effect is in the right direction for every single stat on every single group. That shows a very broad benefit for adding it into the treatment guidelines.
But it's especially powerful in the critical group, so I see why the FDA said just go focus there and let's get going on this.
Critical Group Analysis: So we know the headline number on all-cause mortality for the critical group -- it was roughly 25% fewer deaths. But in the critical under 65, it was a 61% difference -- massive.
If you look at the critical group that got the "common care" they get now, the differences were even more massive. This is the group that represents what a critical patient would be getting today, so the most relevant group for critical patients. The all-cause mortality was 36% fewer deaths, but for the under 65 it was a massive 73% difference in relative deaths!
If you were a dexamethasone only patient, no matter if you were critical or severe, there were roughly 24% lower deaths relative. If you were under 65, it was another massive 52% drop with Vyrologix.
For discharging alive, in the critical group and under 65 Vyrologix had more than twice the rate, 28% versus 10%. And for the critical group over 65, NO ONE WAS DISCHARGED ALIVE -- Vyrologix had 21% discharged alive.
Just look at the charts, every single group and every single stat you see Vyrologix beats the placebo group. So the one main weakness was there was a group of severe patients, not using dexamethasone or under common care, and Vyrologix didn't do much different than placebo and it brought the overall mortality number down. Otherwise, literally every other reading Vyrologix improved the patient and if you are CRITICAL and under 65, it was a MASSIVE help. THAT IS CLEARLY WHAT THE FDA SAW AND SAID, JUST FOCUS IN THAT GROUP. IF they even do half as well with the next 140, it's easily at the Primary Endpoint. Truly solid numbers in that group. Also, if you are under 65 and on the common care or dex, comboing with Vyrologix really improves your chances of leaving the hospital alive and leaving quicker.
These show what is a very clear path for efficacy and where to use it. Had they known before how effective it would be on Critical OS2 patients under 65, they should have tailored the trial, but you learn by doing these trials. They have learned as have the FDA and they are now doing what needs to be done to get this into the treatment guidelines. It definitely works if you are critical.
Lastly -- THEY WROTE HORRIBLE PR ON THIS.
So for the entire group of severe and critical, if you were in the common standard of care or dexamethasone, there was a statistically significant all -mortality benefit !! Done-- there's your primary endpoint met. There's a little bit of overlap between those two groups, but it is by far the majority of the entire trial. It was between 230-310 of the trial patients. So the vast majority were in one of those two categories or both. The failure was in severe only patients not getting the current standards including dex or whatever they defined as "common". Otherwise, it was a huge Passing Grade. They really botched how they explained it all. They desperately need smarter IR and PR to pull these things together better. Instead of being at $10 -- it's a $3! That cost them $7 at least in value.
Less
spoiler
I can see why the FDA asked them to keep going. The delta on every factor in the critical group (OS 2) shows very strong efficacy. The data also shows that Vyrologix is actually a very strong candidate for an add-on combination strategy with dexamethasone and the new standard of care. In each of those cases, there was a statistically significant benefit. If you add the two of them together, you have 90% of the group (and likely 100% of what is being done now in ICUs), and the numbers are well over significant and very strong.
If you look at the bar charts -- in every single group and subgroup, Vyrologix improved the condition of the patient. So while one can quibble with stat sig, the treatment effect is in the right direction for every single stat on every single group. That shows a very broad benefit for adding it into the treatment guidelines.
But it's especially powerful in the critical group, so I see why the FDA said just go focus there and let's get going on this.
Critical Group Analysis: So we know the headline number on all-cause mortality for the critical group -- it was roughly 25% fewer deaths. But in the critical under 65, it was a 61% difference -- massive.
If you look at the critical group that got the "common care" they get now, the differences were even more massive. This is the group that represents what a critical patient would be getting today, so the most relevant group for critical patients. The all-cause mortality was 36% fewer deaths, but for the under 65 it was a massive 73% difference in relative deaths!
If you were a dexamethasone only patient, no matter if you were critical or severe, there were roughly 24% lower deaths relative. If you were under 65, it was another massive 52% drop with Vyrologix.
For discharging alive, in the critical group and under 65 Vyrologix had more than twice the rate, 28% versus 10%. And for the critical group over 65, NO ONE WAS DISCHARGED ALIVE -- Vyrologix had 21% discharged alive.
Just look at the charts, every single group and every single stat you see Vyrologix beats the placebo group. So the one main weakness was there was a group of severe patients, not using dexamethasone or under common care, and Vyrologix didn't do much different than placebo and it brought the overall mortality number down. Otherwise, literally every other reading Vyrologix improved the patient and if you are CRITICAL and under 65, it was a MASSIVE help. THAT IS CLEARLY WHAT THE FDA SAW AND SAID, JUST FOCUS IN THAT GROUP. IF they even do half as well with the next 140, it's easily at the Primary Endpoint. Truly solid numbers in that group. Also, if you are under 65 and on the common care or dex, comboing with Vyrologix really improves your chances of leaving the hospital alive and leaving quicker.
These show what is a very clear path for efficacy and where to use it. Had they known before how effective it would be on Critical OS2 patients under 65, they should have tailored the trial, but you learn by doing these trials. They have learned as have the FDA and they are now doing what needs to be done to get this into the treatment guidelines. It definitely works if you are critical.
Lastly -- THEY WROTE HORRIBLE PR ON THIS.
So for the entire group of severe and critical, if you were in the common standard of care or dexamethasone, there was a statistically significant all -mortality benefit !! Done-- there's your primary endpoint met. There's a little bit of overlap between those two groups, but it is by far the majority of the entire trial. It was between 230-310 of the trial patients. So the vast majority were in one of those two categories or both. The failure was in severe only patients not getting the current standards including dex or whatever they defined as "common". Otherwise, it was a huge Passing Grade. They really botched how they explained it all. They desperately need smarter IR and PR to pull these things together better. Instead of being at $10 -- it's a $3! That cost them $7 at least in value.
Less
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