Hey EQZ, soon you will be able to top up until your hearts content l have terrible preminition which l hope is totally wrong. The cancellation of the FDA application on the week it should have been announced has me extremely suspicious of the Americans. It would have to raise questions about their propriety, because they could have let the almost 60 day applicants be heard before banning new applications one would rightly think. All does not meet the eye on that score.
Secondly the point you raise is like the elephant in the room no one wants to talk about. Why didnt Richard apply for significant device status? We need a firm answer on that given things fell in a heap and significant shareholder value has been eroded from the company which otherwise might not have been.
Third, now we have seen how ground rules can change so quickly, are we totally confidant the Yanks will grant FDA approval. This is the big boys league and lots of hidden agendas operate behind closed doors. PIQ is not a Britsh company like Renaltex, so my concern is they could quite easily knock us back as a small Australian start up that nobody cares about. If they did that, no heads would roll and it might benefit some of their home grown biotecs in the making. Prior to this little in ursion it seemed automatic like rubber stamping our FDA application. Now the seeds of doubt say dont count your chickens before they hatch. A knock back would knock the stuffing out of the SP even if there is an appeals process. l dont trust the Americans but l guess l have to suck it up and hope all is kossure.
cheers.
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Ann: Proteomics files US FDA 513(g) regulatory submission, page-23
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