A serious question......, page-2

That is indeed a good question Broker67, one that I believe I have an answer for.

As the pandemic commenced, mesoblast signalled it's intentions to run trials in both Australia and the USA. At the time cases were starting to rise in the USA but were huge in Europe which was starting to report mass casualties and ER overruns. Australia was quick to move and close the internationl boarders aswell as internal boarders, and significantly reduced the intake of international arrivals. Because of this, there were practically zero cases in australia around the Feb 2020 time when Mesoblast wanted to test the first 12 - which was completed in New York Mt Siani which was completely overrun with casualties. Following this, Australia's hard boarder stance kept the Covid numbers in ICU really to an absolute minimum... a handfull, which has not really changed.

To run the phase 3 trials, at the time there was something like over 100 clinical trials being run by different pharma companies.... so you can imagine getting sick and being offered 1 of 100 different experimental treatments. It's a numbers decision, and as it turned out even with 20 plus overwhelmed hospitals full of patients, to recruit over 200 patients still took around 6 months - probably due to the other 100 + trials being run in parallel.

If the trial was running in Australia for the TGA, it would still be going, and would not have reached 200 yet in my opinion. You need patients to agree to it, and you need doctors to agree to a science experement.... when there are 10's, 100's of other experiments using drugs they are familiar with. So you need 10's of thousands of ICU patients in order to get enough doctors and enough patients to agree to take part.

The good news is that more than likely if the FDA approve, the TGA will probably also accept the FDA approval as theirs and may not require any more data.