Well guys, my broker contact received a brief email back from David Garvey this afternoon, and he'll be talking to him tomorrow in a bit more detail. Here is the feedback - as a precursoe to further discussions tomorrow:
Mr Garvey said that all of PXS's public announcements, investor presentations, etc have referred to a further study in bronchiaectasis and he says that PXS are budgeted and funded for it.
They believe one study will be sufficient for both regulators and the study will probably now contain more non-US sites/less US sites which will actually REDUCE the cost. The scientific advice they received from the EMEA was ACCEPTED AS SOUND in that it positions PXS for a label claim that attracts the pricing they want for the product without any additional cost (as the study was already scheduled).
Obviously the trial will delay commercialisation and cash flow as is evidenced in the Wilsons Note posted earlier this evening but I am comforted - relatively speaking - that this will not incur costs NOT ALREADY budgeted for.
I can handle the delays but I was VERY worried that these trials were unexpected.
If I get any feedback of substance tomorrow I will keep you all informed.
Regards
Coop
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