RE:Sami
Mrlucky wrote: - The Company is working with Baxter on a sub-study to obtain FDA approval for hemoperfusion for Baxter’s Prismax device; the Prismax, with its leading installed base, is anticipated to be the primary device utilized for PMX treatments on commercial launch.
wasn't Sami going to be the future for PMX treatments....perhaps this is where the fallout with Infomed began
Excellent point.
Prismax approval ensures more immediate, out of the gate usage of PMX post fda approval ( if it happens) ... especially with their large pre-installed base.
perhaps Infomed is not thrilled, but I question their ability to deliver SAMIs on a big scale for the US. I suspect they need to show that they have sufficient capacity to deliver both SAMI and DIMI on a large scale. Add in supply chain concerns, and the need to obtain dialysate bag approvals for NA and you realize that Infomed has lots to do yet.