Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

SomatoKine User Fee Goal Date Extended to Oct. 3, Insmed Says

This article was originally published in The Pink Sheet Daily

Executive Summary

The insulin-like growth factor therapy is under priority review for the orphan indication of growth hormone insensitivity syndrome. The original review deadline of July 3 is being extended to allow FDA time to review a major amendment to the NDA.

You may also be interested in...



Insmed iPlex Growth Agent “Approvable” Letter Leaves Orphan Status Issue Open

Exclusivity discussions with Office of Orphan Products Development are ongoing, CEO Geoffrey Allan says Sept. 28; letter requests chemistry, manufacturing and controls data.

Insmed iPlex Growth Agent “Approvable” Letter Leaves Orphan Status Issue Open

Exclusivity discussions with Office of Orphan Products Development are ongoing, CEO Geoffrey Allan says Sept. 28; letter requests chemistry, manufacturing and controls data.

Tercica’s Growth Treatment Increlex Clears FDA With Orphan Drug Exclusivity

The company plans to launch the extreme short stature therapy in January with a 30-member sales force.

Topics

UsernamePublicRestriction

Register

OM017301

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel