In the last ER call, they stated the new manufacturing facility which is online, can produce $80 million in filters. They have a ton of capacity. They did not break down how many filters that is, but consider they have close to 80% margins, so you can do that math if you want.
well, if you think about it, even at current production, 80,000 cartridges, why would any entity prevent any proven therapy from helping as many people as possible, versus no one? I cannot imagine that potential issue, being a "game stopper."