What do they want?, page-6

Nice time line there Torpy, good to see the detailed progression - thanks.

Definitely illustrative of just how much body of work needs to be done to get us eventually to commercialisation! It spans years.

The good news is that they don't have to do the same repetitive work for each and every strain of MPS and in fact the higher and broader classification of Lysosomal Diseases. Once they get enough evidence for a couple of these strains linked together, it should be enough to formulate a Phase 3 (in my view) and that will be the eventual path to registration. I hold probably around 10% chance that we may get this phase three opened at some point but not sure on the chance of that.

As it is novel drug (though repurposed) we may need to prove it in the larger number set in a full length P3? It would be ideal if half way through such a P3 if we reach a tipping point and the FDA say we can start selling as long as we keep the P3 going meanwhile? Its these sort of surprise elements that are so completely NOT factored into our share price, let alone the whole MPS indication as a meaningful future revenue stream.