Replies to post #3383 on PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[CYDYWinning]

Thank you !


Mr. Bashan continued, "The BRIGHT study is the second Phase III study of PRX–102 in Fabry patients that we have completed as part of our comprehensive PRX–102 development program. We announced positive results earlier this year from our Phase III BRIDGE clinical trial, and we anticipate results from an interim analysis of our Phase III BALANCE clinical trial in the first half of 2021. In addition, earlier this month, we announced the filing of the PRX–102 BLA by the U.S. Food and Drug Administration with a PDUFA target date of January 27, 2021."


I hope the PDUFA date is still on target. Looking into it now. Looks like they have a good chance of approval in the U.S.