Ann: PainChek receives FDA regulatory guidance, page-77

A mate of mine forwarded this email he received from PD responding to some questions he had about PCK timelines, pretty much confirms what we already know, however, I doubt we will be waiting many quarters before the contracts start rolling in.

Hi XXX,

Just a few comments which are all in the public domain

1. We are focusing on Europe and Australia for the next 18 months and have good market traction already. This has been communicated consistently to ALL investors since we listed.
2. We have four existing paying customers and a significant number of RAC’s trailing the App in Aged Care some of whom are already moving to contract negotiations. We have recruited sales management and clinical support to in Q1 2018 to accelerate the process. This is a relatively rapid take up of a novel technology.
3. Installing the App is rapid (now via the App Store) and training only takes 1-2 hours per site. This is a low cost of sale business model.
4. There is no change to the data collection process – in fact we make it easier as the pain assessment data is carried out at the point of care (by the resident) and stored automatically – no double handling of data.
5. In terms of FDA De Novo process for PCK in comparison to other Apps
   1. We have significant clinical data already available to support the submission
   2. We are likely to be rated in a low risk class which can speed up the regulatory process
   3. We do not plan to enter the US market in the next 18 months - as ANZ, Europe and other CE mark markets are the priority and represent 40% of the global market potential. Therefore receiving FDA regulatory clearance in 2019 would fit in with the current business goals and strategy.

Hope this helps.

Regards
Philip



Philip Daffas