Quote:
Originally Posted by stylez2k4
Drugs don’t get certified. They get approved.
This is a poor understanding of the approval process. There is no backdoor. You are seeing correlation not causation. If a drug gets approved by a regulatory body, it is because they have a solid NDA. If you have a solid NDA, you are of course more likely to get approved by another regulatory body.
FDA is also regulatory body not a governing body.
If you are not an expert, why do you think 44,00 test group is small? What are you basing that determination on?
|
I’m using certification as the medical device term, if you want to get hung up on that go ahead.
I’m basing 44,000 being “small” based on the resulting groups it will be distributed to and other vaccines and treatments which had a similar sized test group which do not apply to nearly the amount of people the Pfizer covid vaccine will. I do agree though that the statistical analysis based on this test group will scale to the general population.