2004N-0408 - Regulatory Site Visit Training Program
FDA Comment Number : EC12
Submitter : Ms. Denise Scheffler Date & Time: 10/23/2004 04:10:05
Organization : Neuronyx, Inc.
Drug Industry
Category :
Issue Areas/Comments
Neuronyx,Inc. is a development stage biopharmaceutical company focused on cell therapy. Our goal is to develop an allogeneic cell product for use in cardiovascular disease, stroke and diabetes. Our lead program is focused on the use of the Cell Product to enhance the recovery of cardiovascular function following myocardial infarction.
We are interested in participating in the Regulatory Site Visit Training Program and providing CBER the opportunity to visit our facility and observe our manufacturing process. We welcome the prospect of providing CBER with an understanding of our early-stage manufacturing operations as well as a chance to open a dialog with CBER regarding our development of an allogeneic cell therapy product.
If you have any questions, please do not hesitate to contact me at
(610)458-0421. I look forward to your response and our participation in the program.
Denise E. Scheffler
Director, Quality Assurance