Ann: MSB Annual Financial Results and Operational Progress, page-187

This is my view only, but MSB had three key factors playing into their hands when the Mt Sinai results were released and the COVID phase 3 trial was announced.. firstly, it was the peak COVID, secondly Mesoblast had a BLA / approval process later in the year for Ryoncil which was the same Rem-L used for the COVID ARDS trial. And most importantly the potency assay issues were not yet known by the FDA at that time.

Before the FDA issues an EUA, the FDA must ensure they are happy with manufacturing as if they were going to approve the product.

So the situation now is quite different, in that the Ryoncil CRL was issued in Oct20 and so the FDA now knows about it and so it is asking Mesoblast to deal with that issue now, so if Rem-L works in the trial.. they don't have to deal with it then. I think this is the right way to go about it, because if MSB can't convince OTAT, then a successful phase 3 COVID ARDS trial will not be approvable or an EUA cannot be issued anyway.

Either way you look at it, the FDA has given clear guidelines as to what MSB needs to do to get an EUA. Agree the potency assays upfront, run a phase 3 trial and if positive you'll get your EUA... and if Ryoncil is approved already, it could be a quick label extension.. and MSB has two fully approved products on the market, just like that.

We are likely going to find ourselves in a similar frenzy next year once the Ryoncil BLA is back online, and another COVID trial. This time the BLA will have the ODAC vote 9-1 already behind it (efficacy tick), and the OTAT tick of approval (manufacturing), and the only other element is safety which Rem-L has an impeccable record. And the COVID trial will be targeting under 65's with Dex, so the dose and target is optimised.