Pink Sheet is part of the Business Intelligence Division 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

Spectrum's Apaziquone Pooled Analysis Can't Make Up For Negative Studies

Executive Summary

Faced with two unsuccessful pivotal trials, FDA advisory committee concludes substantial evidence of a treatment effect in non-muscle invasive bladder cancer has not been demonstrated.

Advertisement

Related Content

Keeping Track: FDA Approves First Rx DHEA, Receives Applications For Midostaurin, Gesulkumab, Biosimilar Avastin
A Cautious Guide To The Interpretation Of Clinical Trials From NEJM
FDA Oncology Advisory Committee Is Still Pazdur’s Center of Excellence
Keeping Track: Opdivo Dosing Simplified; Yosprala, Cuvitru Approved; Telotristat Review Lengthened
Spectrum Failed To Heed FDA Advice On Apaziquone, And Is Paying The Price
Spectrum's Apaziquone: Can Two Failed Studies Lead To An Approval?
Spectrum regains apaziquone from Allergan, to file US NDA on pooled data

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS119129

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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