PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[Spideyboy]

Just listened to yesterday's webcast. Of note when going though the timeline slide, Dror said the following.

While we are more than half way through the [PRX-102] review cycle, and the inspection will be able to be conducted either onsite or virtually, we are very much optimistic the review cycle will be ok, and we are encouraged so far with the progress.

One wonders if the FDA has responded and Type A meeting and/or if it has happened already and thus, if so that this would seem optimistically upbeat.

I do hope given the priority review designation and the potential superiority demonstrated in the Bridge study over current ERT, that the FDA could make this happen.

Bright study seems on-track for Jan - Feb Topline Data, potentially prior to PDUFA date.

12 months for all patients in Balance was accomplished in October, data probs out 6 months later so probably April 2021, which would provide data for EMA submission.