RE: Still in City hands16 Feb 2021 22:23
Kaeren
Just My Interpretation:
From the AVACTA board -
Muck165 Premium Member
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No Opinion
RE: Usa16 Feb 2021 20:59
The FDA recently posted this on its FDA Virtual Town Hall series page
https://www.fda.gov/media/145829/download
It links through to more detailed stuff at
https://govtribe.com/file/government-file/fa811921sc001-aoi-0003-fa811921sc001-supply-chain-covid-19-diagnostic-testing-final-dot-docx
Looks to me like the US are following the U.K. lead by putting in place mechanisms to massively bolster its domestic Covid supply chains. No bar to foreign test manufacturing as long as actual manufacturing done in the US, but we would need EUA by 31 March (which seems unlikely..)
But you never know...!
++++
The first Link appears to be about financing:
"Capacity expansion investment funding for vendors that have
developed or are developing products relevant to COVID-19
diagnostic tests
Supply chain materials and equipment in scope (see AoI for all)
– Sample collection and testing consumables
– Raw materials, components, processes supporting diagnostics
tests, kits/cartridges and related instruments
– Equipment to expand manufacturing capacity and/or increase test
throughput
– Manufacturing and equipment related to temperature sensitive
diagnostic testing, including their distribution and storage
Some Limitations
– Does not include distributors
– Manufacturing expansion limited to domestic or within US
territories, although manufacturers may be foreign-owned"
Having looked briefly at the second link, it would appear to be about manufacturing capacity increase:
"..rapidly mature and scale specific manufacturing
capabilities within the diagnostic testing supply chain, including (but not limited to) the raw
materials, resources, components, equipment, and enablers utilized in the production of analyzers,
reagents, test kits and other pre-analytical, analytical and post-analytical diagnostic materials for
COVID-19 testing."
++++
IMO, I believe if the contracted US OEM felt they needed finance or assistance under this program, they could apply for it, but that Novacyt per se would not be involved.
It would be for NCYT to encourage the OEM to apply if they felt the OEM would benefit.