Ellume received approval after 5 days I believe, so yes a week...

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markess01

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13/02/21

23:47

Post #: 50963859
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Originally posted by captainblood: ↑

in the last interview with Derek, he talked about the CE approval which should be granted before the end of q1. and they will be submitting our validation studies a few weeks beforehand.

so that would be around the 10th march. from Monday just over 3 and a bit weeks away.

we also know from the quarterly and interview that we are close to completing laboratory studies with VIDRL and the mass production run from Operon that is a pre-requisite for finalising clinical trials and regulatory approval.

from our 26 nov announcement.

"The Company remains on track to commence clinical trials for the COVID-19 ART test in December.
As previously announced the clinical trial procedure has been approved by the Therapeutic Goods Administration (TGA), and discussions with Victorian Infectious Diseases Reference Laboratory (VIDRL) a unit of Doherty Institute, the laboratory undertaking the trial, are well advanced."

so we have to gain TGA approval 1st. in that 3 and a bit weeks we should announce our sensitivity and specificity results, then hopefully in 1-2 weeks afterwards we will receive our TGA approval. the TGA approval and any extra documentation would then be presented to the European regulators.

so looking at timelines I would imagine that we could be receiving our sensitivity and specificity results this week. that looks about right for timelines indicated. ellume released their results about 1 week before FDA emergency approval. I suppose once documentation is presented to the TGA, it becomes public knowledge and needs to be announced.

in regards with the VTM issues, the trial being conducted by VIDRL was laboratory validation study, the same as we conducted in house and operon as well. both used samples stored in a solution using VTM. and the result from both those showed fantastic results with our swab Covid art test with reading samples over 30Ct and readings as low as 0.02ng/ml.

these are the results that future success of our platform of covid tests will be based on. GLTAH.....

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Ellume received approval after 5 days I believe, so yes a week at the most all going well for us. Considering TGA are working with Doherty if I’m not mistaken.

ADO Price at posting: 22.0¢ Sentiment: Buy Disclosure: Held
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Ellume received approval after 5 days I believe, so yes a week...

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Ellume received approval after 5 days I believe, so yes a week...

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