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Totally off topic, but I’m really looking forward to the return of spitting image
Definitely not me Tayboy. I thought me thinking of the Boris puppet from the new Spitting Image !!!!
correct @SiriusB - 200 UK /EU minimum of 20 US
Ophidian
SiriusB is the dirty dog .......
You don’t need anywhere near that number for the clinical validation results.
I expect we will see S&S results and CE mark in the first week of Sept.
New gold standard BAMS test between now and then
Wolfie, it’s sounds like you’re keen..... you dirty dog ;)
Think we might need to introduce some version control ;-)
Tayboy ... re " I’m thinking ram a 1000 people in a room and get them spitting" .....
Do you have anyone in mind to go into that room???
Probably best not to get them in a room, social distancing and all that. For me, this is where Condor swoops in. I’d have had concerns over getting access to samples otherwise. I agree, I’d be very hopeful we should have the required number of sample very quickly with this govt backing.
This was really helpful thanks.... so the question is how long does it take to firstly produce validation batches, then how long does it take for clinical validation of those batches, tahinis when we’ll get news on sen/spec. Forgive my naïveté, but my first thought was if both stages are being fast tracked, the first stage would have a fairly rigid process (actual manufacturing) whereas stage 2 could have bandwidth to really shorten the typical timeline.... I’m thinking ram a 1000 people in a room and get them spitting.
CEO explains the process courtesy of tweet :
https://twitter.com/Tweet_trader01/status/1291300252734173184
just as a reminder - the "Timeline" was originally posted not as an attempt to predict "D-day" but as a demonstration of the complexity of the tasks and how paralleling some of them up could work. Sure - and end point gives some level of insight but it is more about the process which I think RNS after RNS and company presentations have now demonstrated to have been almost 100% spot on. When exactly these things happen is fuzzy what HAS to happen and how they can be ordered and their interdependencies is for me what counts as helping indicate probable progress. Sure I got the longer than expected optimisation period quite wrong but I also think I have identified why and what caused it. (I also think it was 100% out of Avactas hands - I think Cytiva dropped the ball by following US thinking not UK/EU) and had to bsically re-do a stage of development over).
Ophidian
Think your timeline is pretty much on the money Ophidian.
Ophidian your timeline is spot on for this webinar
Webinar 10th SepWed 19:28
Interesting !
https://twitter.com/govscisource/status/1290698546522599429?s=21
First defined 13th June (updated with Viral inactivation 21 day delay 2nd Aug) updated after RNS 6/Aug
1. R&D work to establish a proof of concept - DONE
2. Development work to establish the design to take forward - DONE
3. Collaboration with third party device manufacturer to define product - DONE
4. Third party device manufacturer established final design to take forward - DONE
5. First batches to final design made at pilot scale (and put on stability to generate supporting data) - DONE
6. Examples from pilot scale devices supplied to Avacta for further evaluation and lab testing - (these are probably what he calls Prototypes) DONE
6b (New Step) Optimise LFD for viral inactivation (optimisation) DONE
7. Additional batches made again at pilot scale to clinical standards for first time clinical evaluation. Supplied Wk1/Wk2 Aug Happening Now - Time to complete clinical Validation ~21 Days
8. In parallel with clinical programme; Scale up to production scale. Include Tech transfer and validation batches (again put on stability to generate data) - Happening Now
9. Evaluate data from clinical programme (establishes the FINAL Selectivity and Sensitivity of the test) Aug Wk3 &Wk 4
10. Generate the Regulatory dossier including clinical data, stability data, development data and supporting data from early designs wk4 Aug
11. Submit Regulatory dossier and if not already ongoing be manufacturing launch stocks 1st - 8th September ish
12. Get approval Wk2 September
13. Start selling Wk3 September