Winstgevend schreef op 9 april 2018 16:57:
Pharming TOP ontwikkelingen voor 2018
This
sustainable base allows us to now broaden our scope and focus
on the
near-time clinical development of more convenient ways for HAE patients
to use RUCONEST®, such as intramuscular and sub-cutaneous injections,
but also on research into the application
of
needle-free and pain-free technologies with RUCONEST®.
The further development of RUCONEST® to extend the HAE franchise
also accelerated:The filing with the FDA of our
sBLA for propyhylaxis of HAE in November
and acceptance for review by the FDA of the dossier, in January of this year
and the completion of our
paediatric trial to treat HAE attacks
in children from the age of 2 years of age and upwards
were significant step forward to underpin
the proven efficacy and safety of RUCONEST® further.
During the year we have also taken the next steps
in the initiation of clinical development for additional indications
for RUCONEST® outside of HAE,
ncluding support for
as-yet undisclosed Investigator Sponsored Studies
and results of one of these studies may already become available later this year.
Over the year, we have continued to make progress on bringing forward
our pre- clinical pipeline of products developed
using our proprietary technology platform.
The first of these new products;
human recombinant a-glucosidase for the treatment of Pompe disease,
is now
undergoing upscaling of manufacturing to produce supplies
for the clinical testing and is expected to complete the final steps
to
IND filing stage in 2018, and
we will be providing more clarityon these timelines during the
course of 2018.en nog steeds......... 1 Euro en 3 duppen per aandeel.