KnockOut schreef op 30 maart 2021 21:05:
@Phill & Lego. Hier ook redelijk wat PLX ingekocht na de laatste offering. Uit het jaarverslag van vandaag:
The FDA set a PDUFA action date of January 27, 2021. However, as previously announced in November 2020, the FDA subsequently extended the PDUFA action date to April 27, 2021. As we disclosed last year, the FDA has advised 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 its 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. The Company, together with Chiesi, is addressing this issue.
Die voorlaatste zin geeft toch weinig vertrouwen dat er goedkeuring komt eind april... Voor de rest goed rapport lijkt me.