This all may seem unfamiliar and uncharted territory… but there is some value in looking at other similar stories to what Meso has been and is going through right now.
one such company is Amacus Therapeutics, have a look at the their pathway to approval for Galafold. Whilst not a biologic, the pathway to approval strikes many similarities to what we are going through now.
and worth to note, if we get approval for ryoncil… we will get an insight into all the FDA correspondence (albeit redacted) which will be made public… that will be quite the read.
goodluck all
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