[old spanish trail]

[quote="BostonCard" pid='300748' dateline='1607740162']
People talk about why can't the FDA just move faster given that the efficacy is clear and the safety is acceptable, but the answer is that there are thousands of details in the documentation furnished to the Agency that reviewers pore over, everything from the assays of the raw materials, to the factory GMP certifications, to the qualifications of the people running the clinical trials.  And now what you have created is an atmosphere where you are telling people that none of that matters because the President wants his EUA.  I think we would all be horrified if 6 months from now it is discovered that one of the batches has a carcinogen, or was not sterile, or any one of a thousand different things that could go wrong.  The last thing you want is a 737 MAX situation to happen with a vaccine; it would destroy the credibility of the agency for decades.


BC

Amen! Let the FDA do their job. It may not be pretty but it is usually through and effective. If they are going to approve something that later turns out to have issues (which inevitably does happen), let it be with their process, not some rush job. Both the congress and previous POTUS have prodded the FDA to eliminate unnecessary delays, and this is proper and reasonable. Threatening somebodies job if a certain result is not not delivered by a certain date is totally inappropriate.

_______________________________________
He is an absolutely terrible person.

[old spanish trail]

[quote="BostonCard" pid='300748' dateline='1607740162']
People talk about why can't the FDA just move faster given that the efficacy is clear and the safety is acceptable, but the answer is that there are thousands of details in the documentation furnished to the Agency that reviewers pore over, everything from the assays of the raw materials, to the factory GMP certifications, to the qualifications of the people running the clinical trials.  And now what you have created is an atmosphere where you are telling people that none of that matters because the President wants his EUA.  I think we would all be horrified if 6 months from now it is discovered that one of the batches has a carcinogen, or was not sterile, or any one of a thousand different things that could go wrong.  The last thing you want is a 737 MAX situation to happen with a vaccine; it would destroy the credibility of the agency for decades.


BC

Amen! Let the FDA do their job. It may not be pretty but it is usually through and effective. If they are going to approve something that later turns out to have issues (which inevitably does happen), let it be with their process, not some rush job. Both the congress and previous POTUS have prodded the FDA to eliminate unnecessary delays, and this is proper and reasonable. Threatening somebodies job if a certain result is not not delivered by a certain date is totally inappropriate.

_______________________________________
He is an absolutely terrible person.