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Monday, October 28, 2013 10:41:08 PM
Thanks for providing link to this Cardiogenics' WDM Capital presentation; slides 16 & 17 provide important information:
Slide 16 -
1.Confirmation that 200 patient Beta Site Study to be completed in Q4 2013
2.Informs FDA Pivotal Study will require only 200 additional patients
3.Informs/confirms that FDA Pivotal Study will be conducted at Wayne State hospitals
Slide 17 -
1.FDA 200 patient Pivotal Study targeted completion date of Mid-Q1 (February?)
2.510K submission to FDA targeted late Q3 2014 (August?)
3.Partnering discussions to complete end of Q1 2014 (Partner announcement April ?)
4.Q4 2014 Launch target date in United States
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