RE: Mologic update is dated 30th September on the EU evaluation database21 Oct 2021 21:52
TW, am not sure this matters to Omega shareholders - where we are tonight
Personal view - I may be wrong but this how I see it.
It’s comforting to see the mologic biotech achieve what appears to be a decent performance via an independent EU instructed trial, the false positives/negative ratio's look good overall, we can’t access the Ct / viral load data but these 2 lines provide comfort
Ok so for tactical reasons it was agreed that Omega would be the entity that applied for EU HUA, I suggest this was due to Omega being the better engineer of the two, hence when the EU asked for a user ability study Omega obliged and we can surmise they cleared the hurdle - not saying Mologic are not competent but Omega have a high standing in the diagnostic industry, their paper/ film is considered top draw and they provide consistently high performance kit.
So we are where we are, waiting on the EU but knowing the biotech element is passable and we have submitted a decent deck which has not as yet been passed or failed - think this is fair comment.
Until last week I thought our only chance to secure U.K. HUA was via the back door of EU HUA but the Government web site indicating there was a possibility tests would be included that are basically in the system has to give us hope we may well be one of the said tests - fingers crossed
suggest Omega submitted their test as well
USA - all down to Mologic that one .
Good luck to all holders, feels like a big few days