FDA - just some waffle thoughts8 Aug 2020 13:47
So on the one hand we’ve got Bill Gates and the Rockerfeller fella Michael Mina banging the drum very loudly at the FDA with templates for people to lobby with. They keep talking about $1 strips that can be made in the billions.
Where are they? In a recent YouTube (sorry can’t remember who posted it, but credit due), MM had a slide with a list of these cheap tests. Some needed bits of kit, others were nasal swabs. He’s pushing hard for a solution that simply currently doesn’t exist. (https://www.youtube.com/watch?v=3seIAs-73G8 - 25 mins in)
On the other hand you have the FDA. They’ve set out their requirements. If there’s currently no suitable high frequency test that fails them, then they’re under no pressure to buckle. There’s simply no alternative at the moment. Now consider they’ve been in communication with Cytiva during development. If they know tests can meet their requirements are on the way, again, they have simply no need to lower them.
The FDA might consider that if Sona can meet them for a POC test and Awacta can for a mass screening test then they’ve set the bar perfectly. Michael Mina would then be lobbying for greater manufacturing of Awacta’s tests instead, it would certainly be top of his list of cheap tests for frequent use.
Awacta meeting their guidelines then means that the barrier to entry for other developers/manufacturers remains high. Eventually the FDA might allow lower sensitivity tests like lower nasal tests to be used, who knows. Globally they might just take whatever they can get, as India have. So whilst it might change over time, but Awacta could initially find themselves in a monopoly and total market dominance. Plus, other countries would see the effectiveness and realise it’s a false economy to use alternatives with lower sensitivity, especially when you add in the ease of use due to the saliva sample. A lot of countries also look for FDA approval.
Everything points to this being incredible, world class as Sir Al has said, we’re hopefully on the home straight now.