I may have oversimplified this a bit too much.
Just to clarify.
MSB was able to get a new protocol with the FDA to take account of stem cells having not the same risks re patient responses.
This would not need to be the case with AHZ and TAVR.
BUT the point is the partner being able to understand and assess relevant risks.
The point is about risk to patient and efficacy. A potential partner who already has a TAVR device and already has a type of valve approved will be in a position to expertly assess this because of the human trials.
It's not got the obstacles MSB had in having to get a new protocol in place.
So I'm giving it an excellent chance of partnership before completion of human trials. Along the lines of the Cephalon/MSB deal.
Ann: Appendix 4C - quarterly, page-44
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