The board … ... needs to convene to determine what more can be done to accelerate the pace of enrollment...STAT
50 is underwhelming / disappointing to say the least
Additional sites haven't been the answer in the recent past, yet once again has been proposed as the solution going forward. It's getting old.
I'm sure Baxter would have some ideas as well.
Nevertheless it does not alter the investment thesis ( in terms of eventual approval of PMX)
In fact Euphas 2 data out of Italy now builds on the case with 30 patients enrolled guided by the EAA.
Mr. Seto, added, “On a final note, I’d like to highlight that we have also funded an observational research study using EAA-guided PMX in Italy. This research study is now complete, and we have had the opportunity to review the top-line results. These top-line results are highly encouraging and strongly support the preliminary data received from our Tigris trial. We anticipate publication of the research study results in early 2023. Given all of these positive developments, we remain highly optimistic about the outlook for the Tigris trial, which we expect to complete in 2023, and remain steadfast in achieving our goal of obtaining FDA approval.”
A second important positive is the advance groundwork being laid by Baxter with respect to prismax ( heavily deployed and will be able to be used for HP) and their decision to spin out Kidneyco. Speaks to their degree of confidence in the eventual end result.
MM