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I think it has been put aside as we have signed an OEM deal in US, maybe we’re not going to distribute from Europe, meaning whoever that is would need the FDA on our tests.
Still thinking Roche.
Just things starting to come together
So maybe:
1. OEM deal in US: Roche (CA 94588 USA)
2. Third-Party Manufacturer: GMP pharma and molecular diagnostic outsourcing and is based in mainland Europe - Roche (headquarters in Basel, Switzerland)
3. Timings of it all, 6 weeks ago for NCYT, 6 weeks ago for Roche... 1 day for FDA approval?! must have been some convincing facts and validation for that! (PrimerDesign Assay 100% homology released weekly)
4. Same test methods stated, oral/nasal swab
5. how many businesses really have capacity to ramp production 10-fold?
6. Roche appearing all over NCYT COVID-19 Instructions for use booklet released today
7. Roche already had FDA approval for Cobas system tests, why would they need to re-approve FDA for COVID 19 test? (dont know if this is relevant)
All IMO but the parts are all there for me
https://www.genesig.com/assets/files/Path_COVID_19_CE_IVD_IFU_Issue_3.pdf?timestamp=1584143164
https://www.genesig.com/assets/files/Path_COVID_19_CE_IVD_IFU_Issue_3.pdf?timestamp=1584143164
Roche Roche Roche.
Which explains why it initially made ZERO sense to us for the UK to be throwing £1m at Qiagen when right here we have the best tests in the world ready to go. It sounded like too stupid a thing to do, that’s because it is. IMO all ties in to NCYT.
Roche and Qiagen:
https://www.genesig.com/products/10006-bk-virus-ce
Page 5 under Notice and disclaimers, “patents owned by Roche”
https://www.genesig.com/assets/files/2019_ncov_std.pdf
Now tell me Roche and NCYT aren’t involved! Qiagen £1m granted, still indirectly to the benefit of PrimerDesign. Tell me that’s not relevant info?
Also, don’t forget Roche advertised our PrimerDesign COVID-19 test on their website homepage about 3 weeks ago (May still be there)
anyone expand on this? Could be a biggie.
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