The body of evidence showing significant efficacy of MSC's for...

The body of evidence showing significant efficacy of MSC's for the treatment of COVID-19 ARDS is only getting stronger. Multiple phase 1 and 2 studies have shown efficacy of stemcells in this treatment in the US and Israel. Remestemcel-L showed significant efficacy in its P3 trial:

• Rem-l + dex reduced 60 day mortality by 75% (p=0.006)
• Rem-l + dex reduced 90 day mortality by 77% (p=0.0037)
• survival benefits were accompanied by significant improvements in ventilator-free days, respiratory function as assessed by ARDS severity, and overall clinical improvement on a 7-point ordinal scale
• Dex alone provided no survival benefit in control patients
• Additionally Remestemcel-L has shown an impeccable safety profile in all patients (adults and children) similar to placebo in multiple phase 2 and 3 trials for the treatment of sr aGVHD

Mesoblast have indicated that they had a meeting with the FDA and so we should expect the formal outcome of this meeting within 30 days (by 30 August).







To illustrate the power of this treatment, let's look at how many patients <65 have died in the US from COVID-19, 126,246 as of August 4th. If this was to happen again in the future Rem-L + dex has the power to reduce this by 77%, saving 97,000+ lives.

If Remestemcel-L + Dex was approved, just in the past 2 weeks it could have saved 1,424 lives (77% reduction in mortality).

https://www.statista.com/statistics/1191568/reported-deaths-from-covid-by-age-us/

Additionally, let's look at all cause ARDS in the US, causing on average 67,719 deaths in <65s annually (before covid). If Rem-l + dex has the same effect in all cause ARDS, then it has the potential to save 52,000 lives every year.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5122485/

If MSB and Novartis are able to find an effective dosage for >65's, then you can double or triple the number of lives that could be saved and potential revenue.

Noting that apart from dexamethasone no other treatment has provided a significant survival benefit in any patient population for ARDS. I don't know how Novartis could walk from this given the huge potential of the all cause ARDS market.

As for the FDA this ticks all the boxes for an EUA, data showing likely benefit (77% reduction in mortality over 90 days p=0.0037) with no safety issues and no alternative treatment.

FDA minutes are due within 14 days... Tick Tock