Quantcast
Search Daily Dose & Film Annex
Loading

BIO SmartBrief

Daily Dose Newsletter

Friday
Apr272012

Athersys ($ATHX) holds meeting with FDA to discuss MultiStem 

Athersys announced that a scheduled meeting with the FDA was held to discuss the results of its recently completed clinical trial involving the administration of MultiStem to patients being treated for leukemia or other conditions that place them at risk of Graft versus Host Disease (GvHD).

  • Additionally, the company discussed with the FDA its proposed plans for the next phase of clinical development, answered questions and obtained feedback on a number of specific issues related to the potential study parameters and proposed trial design.
  • The company intends to provide further information about its plans as it finalizes development of a detailed trial and statistical plan and receives additional FDA feedback.

PrintView Printer Friendly Version

EmailEmail Article to Friend

Reader Comments

There are no comments for this journal entry. To create a new comment, use the form below.

PostPost a New Comment

Enter your information below to add a new comment.

My response is on my own website »
Author Email (optional):
Author URL (optional):
Post:
 
Some HTML allowed: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <code> <em> <i> <strike> <strong>
« Vertex Reports First Quarter 2012 Financial Results and Provides Update on Launch of KALYDECO™ ($VRTX) | Main | AtheroNova Signs Agreement for Development of Clinical Trial Supplies ($AHRO) »