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

Forest’s Faropenem Is “Not Approvable”; Additional Studies Will Take Two Years

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA decision reflects the agency's new position on the need for superiority studies to support the approval of antibiotics, Replidyne says.

You may also be interested in...



Stuck In Reverse: Another Start-up Takes Reverse Merger Route To Public Markets

Deal results in unlikely combination of antbiotics maker Replidyne and device firm Cardiovascular Systems.

Stuck In Reverse: Another Start-up Takes Reverse Merger Route To Public Markets

Deal results in unlikely combination of antbiotics maker Replidyne and device firm Cardiovascular Systems.

Replidyne Shelves Faropenem Program

Potential partners may have been scared off by challenging trial designs, analyst tells “The Pink Sheet” DAILY.

Related Content

Topics

UsernamePublicRestriction

Register

LL1134531

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