Direct has had a fully closed system for quite some time, all the way back to when first trialed. The TFF process was part of this. Only L has had open system manufacturing. Your AI helper is conflating the two processes. What I found interesting is that recent regulatory changes have provided an opportunity to change the IND to take advantage of the new pathway being offered by FDA and others it seems. This keeps them out front of and not lagging behind the new regulations like the bears would have wanted; ). See the section on Direct. Best wishes.
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