As Eire and I have discussed in the past, the wildcard is a...

As Eire and I have discussed in the past, the wildcard is a Humanitarian Device Exemption being granted for ViV by the FDA at some point. That would allow up to 8000 DurAVR's to be sold in the US each year for a profit. Being a blanket coverage, it's likely easier to manage than similar programs in other countries like with Canada's Special Access Program where doctors have to submit a request to Health Canada each time they want to use an unapproved device.

The problem with the HUD is it requires there be no comparable approved devices currently available, and there are currently approved options for the procedure. The question then may come down to how strict is the interpretation of what is comparable. So there may be a chance although I would not put the odds in our favor. Another question is how much evidence will Anteris need to prove that the DurAVR is superior and thus not comparable to currently approved options. It may be worthwhile to start the FDA approved ViV trial as soon as possible because it will be smaller and could be completed sooner than the large pivotal trial if enrolling the 1000 or more patients in the pivotal drags on and on.

So there seems to me to be a potential dilemma: Do you try to run the ViV trial concurrently from the start knowing that it will siphon money and resources from the pivotal, which could delay the pivotal, for the chance to petition the FDA as to whether the DurAVR is comparable to existing ViV options? Or do you wait because the odds may be not good that a HUD would be granted? That's the kind of decision Wayne gets paid the big bucks to make.