Insmed Inc (INSM)

[Christiaan F]

New ruling in EU! has been changed since March this year! Positive opinion to speed up the process of approval!

what is more important is that the second filing is for NOONAN syndrome! So they file for another 30,000 patients in EU with no treatment anymore!

Got also a positive opinion form COMP!!

http://www.emea.eu.int/pdfs/human/comp/18025106en.pdf
Mecasermin rinfabate, from Insmed Europe Ltd., for treatment of patients with growth hormone
(GH) gene deletion who have developed neutralizing antibodies to GH (review time: day 30)

From 10k:

Noonan Syndrome. Noonan Syndrome is a congenital disorder characterized by a deficiency in IGF-1, short stature, heart defects and variable dysmorphic features. Growth failure is a consistent feature of Noonan Syndrome and the response to recombinant human growth hormone therapy has been disappointing, particularly in children with an identified gene mutation.

With an incidence of approximately one in 2,000, we estimate that there are approximately 30,000 children in the United States with Noonan Syndrome.

CF.