Yes, see my earlier post: its as simple as this we are waiting for clarification via RNS that the batch is ready. Then as per the investor presentation:
The Affimer based lateral flow test developed with Cytiva is in the process of technology transfer to BBI Solutions. This process involves scale-up of the manufacturing processes and optimisation of the performance of devices manufactured with the scaled up processes; the first pilot batch will be 10,000 units.
Clinical validation can only be conducted on devices made using the scaled-up process to satisfy CE regulations.
We expect clinical validation to be completed in Q4 dependent on pilot batch availability.
The clinical validation and lay user studies are being designed with Liverpool School of Tropical Medicine.
Completion of verification and validation will allow Avacta to self-certify for professional use, and completion of the lay user study, will lead to an audit by AYacWa·V notified body for CE marking for consumer use.
When the manufacturing development phase is completed and the pilot batch is available, the timeline to clinical validation, CE marking and product launch will be defined more precisely.
Big Al stated he will not rush this and risk failure
RE: Press Conference at Downing Street5 Nov 2020 13:53
I would bet 10 Avacta shares that he will say nothing new.
OR
he says it will be a new test and this board goes mental (again) is it us will it be us must be us could it be us can it be us it might be us it may be us it probably is us or is it Chin-ah
its as simple as this we are waiting for clarification via RNS that the batch is ready. Then as per the investor presentation:
The Affimer based lateral flow test developed with Cytiva is in the process of technology transfer to BBI Solutions. This process involves scale-up of the manufacturing processes and optimisation of the performance of devices manufactured with the scaled up processes; the first pilot batch will be 10,000 units.
Clinical validation can only be conducted on devices made using the scaled-up process to satisfy CE regulations.
We expect clinical validation to be completed in Q4 dependent on pilot batch availability.
The clinical validation and lay user studies are being designed with Liverpool School of Tropical Medicine.
Completion of verification and validation will allow Avacta to self-certify for professional use, and completion of the lay user study, will lead to an audit by AYacWa·V notified body for CE marking for consumer use.
When the manufacturing development phase is completed and the pilot batch is available, the timeline to clinical validation, CE marking and product launch will be defined more precisely.
Big Al stated he will not rush this and risk failure