Game,
Thanks for providing link to this Cardiogenics' WDM Capital presentation; slides 16 & 17 provide important information:
Slide 16 -
- Confirmation that 200 patient Beta Site Study to be completed in Q4 2013
- Informs FDA Pivotal Study will require only 200 additional patients
- Informs/confirms that FDA Pivotal Study will be conducted at Wayne State hospitals
Slide 17 -
- FDA 200 patient Pivotal Study targeted completion date of Mid-Q1 (February?)
- 510K submission to FDA targeted late Q3 2014 (August?)
- Partnering discussions to complete end of Q1 2014 (Partner announcement April ?)
- Q4 2014 Launch target date in United States
Ante