As stated above the FDA approval process is tedious, if they...

As stated above the FDA approval process is tedious, if they (FDA) choose to raise queries then it obviously lengthens the process.  This in itself is not a fault of the company.

The product has so many advantages over the existing alternative that it's a no-brainer choice for people that require it.  Therefore, in my opinion, the sales will flow - this isn't really a discretionary spend.

Whether sales peak in some quarters over others is of no concern to me. It's just noise.  In fact, the quantum of sales at this point is negligible in my opinion.

There is the risk that the FDA does not pass the product, however with each month that passes there are more successful recipients that use Air Xpanders in Australia.  This surely weighs nicely for the FDA's decision.

Therefore - buying opportunity as I see it.