WHO Solidarity Trial Results, page-7

If you believe that remestemcel-l works, and that MSB's understanding of how MSCs work against cytokine storms... then the FDA's CRL citing concerns over the single arm study as insufficient evidence for proof of efficacy is not a red flag, it is merely a red herring.

The FDA isn't saying that rememstemcel-l doesn't work... it is only saying that there isn't enough evidence of efficacy in the form in which they are willing to accept (a randomised controlled trial) it to approve.

The same mechanism of action is being evaluated in a cytokine storm induced illness (COVID-19 ARDS) which is similar to the cytokine storm that causes aGVHD. This is a phase 3 randomised controlled trial that if successful will catapult Mesoblast to the world stage overnight.

Mesoblast have a successful phase 3 SR-aGVHD single-arm trial that 9-1 independent experts voted that they believe in light of all the limitations in the data available, they believe that remestemcel-l shows efficacy against SR-aGVHD. Despite the FDA not holding back and basically leading the panel of experts to vote no... the independent panel disagreed overwhelmingly with the FDA.

Any dip in share price is the market adjusting to perceived risk and reward.. it is up to the individual investor to determine whether the market is either right or wrong.. this is IMO the only way to beat the market.

Do not let the market make that decision for you.

Goodluck all