https://x.com/DrMakaryFDA/status/1935502814945427563@Mani86 only had two thumbs up, so I've reposted the link.
In our latest FDA Direct conversation learn how we're enhancing drug development and accelerating cures for all Americans through the Commissioner’s National Priority Voucher program.
My take- Mesoblast would have to commit to US manufacturing to be considered for a voucher.
Security and Safety of product being paramount concerns.
Security of access to supply from domestic production.
Safety of the product, being produced locally, so that foreign hostile actors cannot reengineer nasties into cells.
Think I'm kidding? Nope- Makary highlights US patients sending their own individual cells to China for gene editing and then they are returned to the US patient. FDA is not stopping the current treatment cycle but is banning this international style cellular swap into the future.
That does not affect us - the video does highlight the push for domestic manufacturing facilities.
Meaning - we will probably be manufacturing sooner rather than later in the USA. Just need a nice approval first.
Reg
(20min delay)