Ann: Mesoblast Management Update, page-48

I would like to endorse what Left-E wrote yesterday. Spot on in my opinion:

I think we have a shot at an EUA for the following reasons. To date the FDA appears to be willing to give emergency authorization on a broad spectrum of therapies to address C-19. On the preventive end of the spectrum they've authorized 3 vaccines. On the opposite end for patients getting ECMO they've authorized Cytosorb. In between we have convalescent plasma and the monoclonal antibody combos to deal with mild disease. Then comes remdesivir (which now has full approval) for patients sick enough to require hospitalization. For more serious cases of pneumonia FDA has authorized baricitinib and tocilizumab. While these authorizations extend to critical cases even ECMO and can be used at a physician's discretion, there's no CRT evidence they are effective such cases. I think the EUA for tocilizumab especially should give hope for sponsors of other therapeutics. Minimal mortality benefit if any. Aviptadil has shown safety and a mortality benefit in critical cases prior to intubation and may get an EUA. But rem-L is the only therapeutic to have demonstrated a mortality benefit in intubated patients with ARDS as measured on the Berlin scale. Short of ECMO, these are the most critically ill and hardest to treat patients and right now there's nothing with demonstrated effectiveness. If a product is proven safe and shows a significant mortality benefit (48% mortality reduced to 14%), FDA should make it available. Clinicians will sort out which is best for which patient. Mesoblast's N is probably greater than FDA required to authorize Cytosorb early in the epidemic. No problem having multiple parachutes in an emergency, especially for the most serious cases.”