PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[king oil]

Possible warning from yesterday's filing re: FDA inspections

Recent Developments

Regulatory Update

On August 11, 2020, we, together with Chiesi, announced that the FDA had accepted the BLA for PRX-102, and granted Priority Review designation for PRX-102, for the proposed treatment of adult patients with Fabry disease. The FDA noted in its BLA filing communication letter for PRX-102 that it is not currently planning to hold an advisory committee meeting to discuss the application. The FDA initially set an action date of January 27, 2021, under the PDUFA. However, as we previously announced, in November 2020, the FDA extended the PDUFA action date to April 27, 2021. As we publicly disclosed last year, the FDA advised us that it will have to inspect our manufacturing facility and the facility of a third party in Europe that performs fill and finish processes for PRX-102 as part of the FDA’s review of the BLA to ensure cGMP compliance. Due to COVID-19-related FDA travel restrictions, the FDA has advised that it may be unable to conduct the inspections prior to the PDUFA action date. We, together with Chiesi, are currently addressing this issue.


This sounds like another possible delay to the April date.