Aedan schreef op 29 maart 2019 09:44:
"Subject to approval, the new form of ruconest® will be
tested in appropriate clinical settings for intramuscular,
intradermal and subcutaneous delivery. The program is
currently progressing slower than previously planned for
technical reasons, mainly because we were unable to divert
the necessary rhC1INH drug substance needed to validate
the new form manufacturing processes and for production of
clinical trial materials away from the ruconest® production
because of high sales demand. This delay allowed us to
restore inventories after substantial amounts of ruconest®
were delivered to patients as (free-of-charge) emergency
treatments, both in the US and in the EU, to provide
them with medicine during periods of acute shortfalls of
competitor plasma-derived C1INH products in late 2017 and
early 2018."