The following are the key short term milestones for the Company:
Completion of patient enrolment in International Clinical Trial | Q3 2007 |
Complete CE mark clinical trial enrolment (20 patients) | Q3 2007 |
Submission of IDE to US FDA | Q4 2007 |
Extension of International Trial to allow additional implants | Q4 2007 |
Submission of Technical Dossier to Competent Authority | Q4 2007 |
Receipt of CE Mark (European Regulatory Approval) | Q1 2008 |
Commencement of US Clinical Trial | Q1 2008 |
First Revenue | Q1 2008 |
Submit IDE Application to US FDA | Q1 2008 |
Approval to Commence US trial | Q2 2008 |
Capital raising | Q2 2008 |
Submission of Technical Dossier to Competent Authority | 2H 2008 |
Receipt of CE Mark (European Regulatory Approval) | 2H 2008 |
Commission new manufacturing facility | Q3 2008 |
Submit applications for European regulatory approval | Q3 2008 |
Commence US BTT Clinical Trial | Q3 2008 |
First revenue | Q3 2008 |
Receive EU reguatory approval (CE Mark) | Q4 2008 |
Commence commercial sales in Europe | Q1 2009 |
Complete Enrolment in US BTT Clinical Trial | Q4 2009 |
updated 7th November, 2008
© Copyright 1996-2019 irasia.com Ltd. All rights reserved. |
DISCLAIMER: irasia.com Ltd makes no guarantee as to the accuracy or completeness of any
information provided on this website. Under no circumstances shall irasia.com Ltd be liable
for damages resulting from the use of the information provided on this website.
TRADEMARK & COPYRIGHT: All intellectual property rights subsisting in the contents of this website belong to irasia.com Ltd or have been lawfully licensed to irasia.com Ltd for use on this website. All rights under applicable laws are hereby reserved. Reproduction of this website in whole or in part without the express written permission of irasia.com Ltd is strictly prohibited. TERMS OF USE: Please read the Terms of Use governing the use of our website. |