We do need to be a little more optimistic about this IHMO
Firstly the recent Quarterly (30th September)stated
“Work is underway to support early market access for the USin 2019, where the appointment of a key reference Laboratory and shipment of anAPAS Independence instrument is expected in the first half of 2019”
“Coinciding with this is the dossier to submit a 510(k) tothe US FDA for the APAS Independence instrument”
NOW we have ……Drum roll…..
First placement of APAS Independence into US Lab
“Training and commissioning of APAS Independence will occurover the coming weeks.”
This is good, this exceeded expectations….. finally.
Secondly today we have also been told
“To support commercialization and sales in the US a 510(k)is required to submit to the US FDA for the automated instrument. APASIndependence. The Company will provide a progress update on the submissionbefore the end of 2018”
What does this tell me……… Well you can’t update the marketbefore the end of the year with
“Still working on it” “up to page 60 now” “40 to go” "dam dropped my pencil"
It is more likely to be
LBT is pleased to announce that today we have submitted the 510(k)supplement to the US FDA. Expectedreview time is 90 days.
So the future might look a little like this….
Australian Laboratory buys multiple machines
Dr Wisplinghoff buys multiple machines, realistically therenot doing all this work with LBT to not end up buying and using the machines.
FDA clearance end of 1st quarter.
So from here we will start to creep up to a range of 0.25 to0.35 especially as certain types set themselves up for the buy on rumor sellon fact component of the FDA clearance.
When clearance is given day traders might send this back upto a dollar like last time.
But when it happens this time we have a product, not one that is two yearsaway.
If anyone is going to the AGM please fill us in afterwards
IMHO
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We do need to be a little more optimistic about this IHMOFirstly...
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