More on cormatrix, page-6

Yeah its interesting, whats important to add is this is ongoing so those results are to date, who knows how much more will be failing next year and the year after that and so on... Only more time will reveal the true extent of the issue.

One of the handicaps for AHZ and our cardiocel is we dont have long term data yet ( as pointed out by the surgeon on the video), however that isnt anyones fault and it doesnt mean we wont get it in the future. We are pointing to good long term data so far but caution willl remain until more years pass.

I know this sounds crazy but I have this view that with FDA and EMA, when they give you an approval,l to use the products in their jurisdictions that there is a secret handshake for a roll out of these. It would make sense for the FDA to say well happy for you to start selling, however in year one I dont want you to exceed x amount of operations, then following year X times 2, and so on. This would protect the community and their decision to allow it.
It would almost be an agreement over a ten year period lets say of how many patients can be implanted in yeach year until that hard long term data comes in.

While superior product, I dont think FDA and EMA would want every surgeon to switch overnight... It would be very high risk for them as well not just tje surgeons. It almost feels like a plan with these 10% increases each month- question is is it the companies doing or was it an agreed rollout step up between jurisdictions?[/QUOTE]