RE: Thermo Fisher PCR test kit12 Apr 2021 23:45
Not about an 11 month timeline. More about not much happened under Trump. He thought that the high level of cv19 was associated with the high level of testing. He slowed everything down in so many ways. Biden is on full speed catch up. We will soon get approval imho. The US have approved the $1.9 trillion budget which includes $50 billion for testing. The policy behind testing favours high throughput PCRs. They are also becoming increasingly positive about poc tests of all kinds. Faster manufacturing, faster test processing with integrated reporting are the priorities now for updated FDA guidance. Tick, tick, tick for GDR.