Hey mate,I respectfully disagree, what really matters for EUA...

Hey mate,

I respectfully disagree, what really matters for EUA is:



Because the comparison is between Remestemcel-L + Standard of Care (SoC) vs SoC, this data would be a problem if we were trying to replace SoC. The above graph shows that Remestemcel-L statistically reduces mortality in moderate to severe Covid-19 ARDS. However, then you can further characterise this with this data which shows a significant increase in potency:



This increase in potency can then be used to develop a clinical dosing protocol for Remestemcel-L + Dexamethasone.

As it stands we are using Remestemcel-L as a complementary intervention to SoC, which is a steroid (Dexamethasone) which is off-patent and super cheap. Therefore, there should be no instance if we get approval where Remestemcel-L should be administered without a co-administration of Dexamethasone, and that can be detailed in the EUA/Approval. In this circumstance, we see a 77% reduction in mortality in this under 65 y/o population, which is the bottom line.

The other thing that needs to be considered is the development stage and evidence level of the EUAs granted to date (some of which were granted on pre-clinical data only). We are in a far superior position to this with statistically significant RCT results demonstrating a marked reduction in mortality. EUAs are relatively non-committal in this way, as they shortcut some of the data requirements for approval, effectively allowing a phase 4 post-market trial due to the circumstances. If a therapy has been shown to not do anything - the EUA can be revoked, or approval not granted, so that when the emergency period passes - the drug still needs to go through the traditional regulatory process.

Remestemcel-L has consistently demonstrated a clean safety profile, so worst case scenario - we're giving patients an expensive water solution and the FDA revokes the EUA upon review of the new data without any harm to the patient population.

• The motivation here is to improve SoC, not replace it.
• Combination therapy of Remestemcel-L with current SoC saves lives.
• We have a far higher evidence level than the EUAs for Covid-19 granted to date.

The case for Remestemcel-L in ARDS is very compelling despite its lacklustre stand-alone data.

Gang gang