just something I was thinking about regarding certification of our test in the UK. used the last webinar and some posts from dalstonian11 (disappeared lately which is a shame)
from the webinar we were close to achieving MHRA accreditation and in the process of starting DHSC in which only 2 British companies have succeeded, with the "performance rating we have" (very interested in new trial results without VTM interference) hopeful of becoming no.3
just as a refresher about our VIDRL results and MHRA requirements post
52460316"In terms of clinical performance, the TPP requires desirable sensitivity of at least 97% tested on at least 150 samples and specificity of at least 99% tested on at least 250 samples. When I first saw ADO's announcement on the Doherty Institute's study results, I was surprised why they carried out tests on so many samples (sensitivity 97.3% on 184 samples and specificity 99.6% on 259 samples) because successful EUAs I reviewed roughly averaged (from my memory) 150 -200 samples in total. If you look through the TPP, ADO meets a lot of the requirements."
so even from initial testing we were covering MHRA requirements.
then we had Derek mentioned in 1 of the webinars about possible UK manufacturing??? D11 picked up on this in this post
53303045"Then in terms of manufacturing, DT did mention that they are in talks on manufacturing in the UK and Operon deal seem to exclude the UK. I just noticed this footnote at the bottom of the UK Government's website:
The technical validation process involves 6 keys steps:
1. Register through the online form
2. Triage of online form by scientific advisor
3. Initial review by Scientific Expert Panel
4. Technical and in-service evaluation
5. Decision by the Technical Validation Group
6. Procurement discussion
[footnote 1]
1. Commercial and supply chain conversations will commence earlier in the process and happen in parallel through the relevant process. ↩"so far the distribution agreement with Apacor is the only agreement we have appointed an agent in Promedt UK to handle registration. happened close on 3 months ago. why only in the UK?
all just speculation at the moment but a lot could be happening behind the scenes at the moment that we won't know until Anns are released.
was the UK trial somehow tied into these applications? and if so are we currently in technology transfer with a UK manufacturer as described above. would increase our 32m capacity a lot.
as I said just a bit of Saturday speculation but the whole process involving the UK has been different to all other agreements and this is a reason to at least wonder why?
anyway, a big week ahead for ADO. ellume deal !!! TGA approval ??? company update with quarterly !!! at a minimum....
