RE: Validate Quickly22 Jul 2020 08:52
This is also what Ophidian said
Here is the Timeline I posted (please note 1-6 are completed so not reproduced here)
7. Additional batches made again at pilot scale to clinical standards for first time clinical evaluation. Supplied Wk3/Wk4 June Time to complete 21-28 Days (end of July)
8. In parallel with clinical programme; Scale up to production scale. Include Tech transfer and validation batches (again put on stability to generate data)
9. Evaluate data from clinical programme (establishes the Selectivity and Sensitivity of the test) July Wk.2s/wk3/wk4
10. Generate the Regulatory dossier including clinical data, stability data, development data and supporting data from early designs Wk2/wk3/wk4 July
11. Submit Regulatory dossier and if not already ongoing be manufacturing launch stocks 1st August
12. Get approval Wk3 August
13. Start selling Wk3/4 August
So to answer your question - right now I expect the clinical validation is taking place and in parallel, Stability data is being generated and compiled into report format,. Additionally I expect tech transfers and scale up activity is also ongoing. You will note - I was not expecting any RNS on LFD before August aside from potentially an announcement of manufacturing partners.
Given what we have heard in the press about the prevalence of the disease it is possible it may take longer to complete Clinical validations due to a shortage of ill people. This was also noted by the company in the videoconference from Cytiva. I don't know that that is the case or not but it's worth noting.