Thanks Dave sss.
This is what we have been waiting for. Seems many hear are more interested in the other camps than what is going on in our back yard.
A lot of very interesting information hear.
Not yet recruing, we are enrolling, the head line of the last announcement confirms. Previous reported as a phase 2-3 trial now phase 3. This must have changed after the FDA got the results of the 12 patients and is likely that this is why the trial went from 240 - 300
Primary Outcome Measures:This is very important for us.
- Number of all-cause mortality [ Time Frame: 30 days ]
Number of all-cause mortality within 30 days of randomization.
Success or --- f ( I shall not say it )
The study is designed to have three interim analyses for stopping accrual early for efficacy and futility when 30%, 45% and 60% of the 300 patients
The first look will be at 30% enrollment + 30 days , just 90 patients.
What will DMC need to take action ? To show that I am not ramping all the time, I will look at ---f first
Adverse events, this is always considered however they would need to be very serious in these settings . We know our safty record.
Looking at survival, 30% or 13 patients or above and they would take a closer look at it when we reach 45%.
Efficacy Match the previous results and this I believe will be triggered, why have a look if you haven't at least some intention to stop the trial. 37 survivors and the trial should be called. That could be in less than 6 weeks.
If the trial proceeds longer than say 2 months it would be a very strong indication that the interim results were short of magnificent however many trials return results
with only very marginal success and questionable safty and still are considered successful.
I am also very impressed with the depth of the secondary outcomes , unless the collection of data and testing is compromised in some way , the out come will be definite. No more trials for this application.
So much more to come in regards to ARDS in the next couple of weeks . The big ones CHF and CLBP are in range now , we have the potential of multi partnerships even with the US government.
All we need is good health for family and friends, stay safe and we will have a wonderful 6 months.
Good luck all.
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