"It's simple. Remestemcel-l is trash, unless proven otherwise. Everyone can say what they want in support of remestemcel-l, but the fact is it has failed every single randomised, double-blind clinical trial, so it needs to be resigned to the trash heap of failed treatments."
Fortunately, @Zenox, it's not as simple as "trash, unless proved otherwise". It could also be hoped that it is the salvation of populations and economies "unless proved otherwise". The latter, contra view is supportable while awaiting the reporting of the secondary endpoints of the Covid-ARDS RCT. Too soon to put Rem-L down for the count. It's not trash unless it fails full results readout.
You are right. Rem-L did not meet the primary endpoint of the Covid-ARDS trial. It fell short of the required 43% mortality improvement. The SOC tortoise was given better shoes and some booster shots and got closer to the Rem-L hare. How much closer, we don't yet know, so we'll have to put mortality aside for the moment. There are more serious issues than death from this condition.
This is not a failed primary endpoint in a trial for an "ordinary" condition like CHF, or Crohn's, or osteoarthritis, or diabetes, or absolutely any other condition ever found to challenge populations and economies. I venture that this is the first ever trial for a condition that challenges civilisation. The overworked word "unprecedented" applies here like nowhere else.
What I am getting at is that this trial did not satisfy the mortality endpoint. That is only part of the story. Have a look at today's newspapers. Mortality is dreadful. The totals are reported. But the articles then run on to what really is worrying governments. Namely hospital capacity; support-staff exhaustion; declining ability to match the increasing demands. It's getting worse despite SOC.
The UK health system is at breaking point. They report a "tsunami" of cases. Today's Sydney Morning Herald carries an alarming report from there.
Los Angeles reports "the medical infrastructure is buckling", "worse is expected", "mortuaries are turning families away".
Skilled medical staff are exhausted. They have surpassed their capacity, mentally as well as physically. Retired nurses and doctors are being recalled. Students are being recruited, reminiscent of Berlin 1945 when 12 year olds were sent into the streets with Panzerfausts. A bit of a stretch, I admit, but the hint of martyrs to futility is there. ICUs are overloaded. British patients are being treated in the ambulances at hospital doors because there's no room indoors. A temporary field hospital is being recommissioned. Nations are desperate. Worse is expected. In normal times ICUs are quite busy with trauma patients, cardiac cases, respiratory patients, post-op monitoring. There is no room in too many ICUs now for these critically ill people. Normal health care has been suspended. And it's not just mortality that's the problem. The RCT results for mortality don't address the full story.
It is no exaggeration to say that many parts of the world, including advanced economies, are on the edge of health care catastrophe. Not my words. The words of frontline workers and administrators.
See the picture? If mortality were the only problem, Rem-L won't help to the degree required by FDA. But what if the early Mt Sinai, small number observations of shorter time on ventilators, speedier recovery allowing discharge from ICU, earlier discharge home from hospital, what if those were replicated in the multiple secondary endpoints being assessed right now? And the additional possibility of reduced return to hospital in months following discharge? What if Rem-L shows statistically significant improvement in these areas over SOC? The answer is being explored right now.
If Rem-L really can show the benefits listed in the previous paragraph I believe there is no chance that the FDA could brush them aside. They could argue all they like about unknown mode of action, manufacturing issues and all the other theoretical objections in their briefing notes for the sr acuteGvHD ODAC meeting but they wouldn't be arguing with the team from MSB. They'd be up against tens of thousands of health workers, numerous politicians, millions of citizens. Their opinion would be irrelevant if enough people are convinced by results.
None of the above is a prediction. I'm just saying Rem-L is not trash vs Covid-ARDS yet. Covid does a lot more than just kill. Rem-L might help. Not long to wait.
(20min delay)