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Well for starters, it would be stupid to pipeline the process so that nobody could start reviewing the code until after it was done. Secondly, I don't believe i
by modeless 6y ago
Well for starters, it would be stupid to pipeline the process so that nobody could start reviewing the code until after it was done. Secondly, I don't believe it's a valid analogy because the process of reviewing clinical trial evidence is not similar to the process of reviewing executable code. Thirdly, there is no amount of review that guarantees a lack of mistakes, so it's simply a question of risk tolerance which you have to balance against the harm of delay.
- apsec112 6y agoThey started rolling review back in October: https://www.pharmamanufacturing.com/industrynews/2020/uk-regulators-use-rolling-review-to-speed-pfizer-astrazeneca-vaccines/ https://www.pharmamanufacturing.com/industrynews/2020/uk-reg...
- modeless 6y agoThat's good (though it should have been earlier) but makes the approval delay even less acceptable. Edit: Actually FDA Fast Track was approved in July. There should be no surprises for the FDA in this submission. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-granted-fda-fast-track-designation-two https://www.pfizer.com/news/press-release/press-release-deta...
- pfranz 6y ago> Well for starters, it would be stupid to pipeline the process so that nobody could start reviewing the code until after it was done. I imagine the expedited process also means summaries and overviews that would normally be presented were skipped--detailed documentation if we're continuing the source code metaphor.