FDA Approval, page-22

Hi Guys,
Was fortunate enough to speak to the company pre-xmas.
Below are my comments:
The FDA approval process takes 90 days max. It is quite common for the FDA to revert with questions. When this happens the clock stops, and doesn’t start until LBT have replied.
The machine will sell for approx USD200k
No distribution deal will be done until FDA approval has been granted, it’s not how the sector works.
A small lab would probably need at least 2 APAS machines as a minimum based on throughput.
APAS is miles in front of the competition. The next best option simply takes a photo of the image which is still analysed by a biologist. From the results of the trial APAS performed better than the Biologist.
The company haven’t decided whether to go with a Global partner or Zonal partner.
Licensing Fee: approx. USD20-25k per year. Obviously the distribution partner gets a cut, but all these funds go direct to LBT as per this graph below. In other words it isn’t split with Hettich.