Timelines15 Jun 2021 09:55
Hopefully the Mologic fiasco puts the slipped timelines in some perspective - it looks like it was less to do with Avacta and more to do with the flawed PD process.
I know we were in PD before Christmas and that we've also been hamstrung by the flawed futility testing procedures - this was more or less publicly confirmed after the Huff Post article, Al's sniping in RNS's and in the annual report. Al's also previously commented on a 'disappointing access to samples' for BAMS.
If one thinks back to when it was announced validation was to take place in Spain, I think you can start to see that a test was ready for clinical evaluation broadly in-line with Al's timelines - but was contingent on the Government for access to validation procedures.
It seems to me the moment Avacta announced they had shifted over to Spain was the moment they pivoted away from focusing on the Government here, likely following several months of unnecessary delay induced by Porton Down.
Given the delays have somewhat dented confidence in the ability of Alistair to deliver, personally I find this new clarity on whats likely happened quite reassuring - I think Avacta have been intensely frustrated by the Government across the later stages of the development process.
That said, we also know from RNS's PHE have been testing AffiDx against variants for quite sometime - which suggests to me that we are still very much in the running for Government contracts. Additionally, PD procedures have been changed to allow alternative validation pathways and recently updated to reflect FDA guidance that live clinical samples should be used.
The whole thing is a complete farce mind - though I suppose when this Government of charlatans has ****ed up every other aspect of the pandemic, why would you think test validations would be any different.
Still, onward and upwards - Europe/ROW awaits...
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