Ann: First Patient Enrolled in Cynata MEND Clinical Trial, page-155

Thanks for sharing this, Bazsa, particularly about the 60 day endpoint marker for critically ill patients. For people interested, you can view the FDA recommendations on P.11 here: https://www.fda.gov/media/137926/download
Those recommendations are based on data from German hospitals, with the report available here: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30316-7/fulltext#seccestitle140

Realistically, I don't think we're much chance of launching a P3 in the USA for the indications in this MEND trial, no matter how strong the results are. That said, assuming good results from the trial this year, Cynata looks to be in an extremely strong position to launch a P3 for ARDS next year in Aus. With lockdowns probably out of picture next year, we will see high numbers of cases and elevated numbers of ICU admissions due to COVID (per Doherty modelling [image below]), so we won't have a shortage of potential patients (and we may even go for the 60 day endpoint this time!)


My holy grail outcome is that we get good results from our P2 trial and influence the government to allow this treatment to be used in parallel with the P3 trial on a special needs basis. Managing deaths and decreasing the time spent in ICU by patients will likely become critically important, and if Cynata can help, then we should be knocking down the door to Parliament house.