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

BMS caffeine study

This article was originally published in The Tan Sheet

Executive Summary

Bristol Myers-Squibb requests teleconference with FDA in "near future" to discuss several questions generated by agency comments on firm's clinical study proposal for trial comparing effects of aspirin/acetaminophen/ caffeine in varying doses with acetaminophen 1,000 mg alone. Excedrin marketer submitted study protocol in July 2001; FDA responded in February that acetaminophen-only arm is unnecessary, trial should include second pain model other than headache (1"The Tan Sheet" Feb. 25, 2002, p. 9). In May 31 submission, BMS maintains "we believe that many of the issues raised [by FDA] will be answered by providing the agency with a full protocol, rather than the protocol outline we submitted" in July. Complete protocol will be submitted after the teleconference, firm says...

You may also be interested in...



BMS Caffeine Adjuvancy Study Acetaminophen-Only Arm Unnecessary – FDA

An acetaminophen-only treatment arm in Bristol-Myers Squibb's planned clinical study on the efficacy of different caffeine doses in analgesic adjuvancy is unnecessary, FDA says in a recent letter

AstraZeneca's Risky Lynparza Endpoint In Pancreatic Cancer Goes Before Advisory Cmte.

US FDA usually recommends using overall survival for pancreatic cancer drugs, but AstraZeneca choose progression-free survival; now ODAC will weigh in on whether the PARP inhibitor olaparib demonstrated a clinically meaningful impact. The firm cites enrollment and design challenges in the gBRCAm population as reasons for using PFS.

Did Sarepta Need To Tell Investors About Its Vyondys 53 Dispute Resolution Request?

Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.

Topics

UsernamePublicRestriction

Register

PS094110

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