Italy 9 months delayed! but... on track to deliver in December.
Israel - still awaiting registration,
FDA 513g now under review - so we can expect a response before the end of the year (usual 60day for responses)
Sounds like we should start seeing some traction in this last quarter, was nice to finally get some explanations. I am very excited to hear ground work has been going on in Italy. We are all waiting to see those first sales for PromarkerD. I know initial sales will be minor but every hay ball starts off as a single thread.
Also some interesting wording around the US LDT version roll-out, it sounds to that we may get some news on lab agreements shortly, which would then be followed by a submission for the unique CPT code. FDA approval for the IA kit still a long way away but getting some traction via the LDT kit would be very positive.
Cash position is the only real concern I see here, CR most likely in Q2 2022 depending on how PromarkerD sales go (in my opinion).
Apart from that, things are looking good!
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Italy 9 months delayed! but... on track to deliver in December....
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