Ann: Proteomics files US FDA 513(g) regulatory submission, page-13

Regardingthe change from ‘pre-submission’ to a ‘513(g) application’ with the FDA forPromarkerD.
It is likely there there will be no material delay to afull FDA submission and the anticipated FDA approval of PromarkerD for the following possible reasons:

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  • • The 513(g) application does not require clinical data to be submitted, resulting in a faster determination of which full application to file (either the De Novo Classification or 510(k) route). There is no issue with not providing clinical data in this initial 513(g) submission, given the extensive data is validated – it simply means the data will be provided once PIQ knows which route.
  
  

• • PIQ will probably file a full FDA submission post the release of the results from the collaborative Janssen study ( probably due in late July/August ? ).
  
  
  

• • Once PIQ has been provided a determination of the most appropriate classification, a full submission can be made (with the inclusion of the robust Janssen data), which we all hope will be successful.