Anonymous ID: fc84a7 Dec. 18, 2020, 11:26 a.m. No.12081758   🗄️.is 🔗kun   >>1963 >>2235 >>2365 >>2372

So everyone picked up from last bread that

Pentagon halting Biden transition briefings is FAKE NEWS

It's a "mutually-agreed upon holiday pause".

 

>>12081655 lb

>Scoop: Pentagon halts Biden transition briefings

>>12081454 lb

>Holiday pause?

>>12081370 lb

>Statement on Transition Activities by Acting Secretary of Defense Miller

Anonymous ID: fc84a7 Dec. 18, 2020, 11:40 a.m. No.12081894   🗄️.is 🔗kun   >>1931 >>2023

Alex Berenson@AlexBerenson

 

So @peterdoshi, a junior editor at @bmj_latest, is among the few researchers raising hard questions about the vaccine trials. Here's another. He's too polite to say it this way, so I will:

HOW IN THE HELL DID @US_FDA REVIEW THE PFIZER TRIAL IN THREE WEEKS?

 

https://twitter.com/AlexBerenson/status/1339994714871881728

with link to:

https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-pfizer-biontech-vaccine/

Anonymous ID: fc84a7 Dec. 18, 2020, 11:43 a.m. No.12081931   🗄️.is 🔗kun

>>12081894

 

Did the FDA understaff its review of the Pfizer/BioNTech vaccine?

By PETER DOSHI and MATTHEW HERDERDECEMBER 17, 2020

 

In what is arguably the most important decision the Food and Drug Administration has made this year — its emergency use authorization of the Pfizer/BioNTech Covid-19 vaccine — the agency apparently assigned only a single reviewer in each of two key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do.

 

The FDA’s authorization last week followed similar authorizations in the United Kingdom and Canada. But the FDA’s decision is particularly important because of its reputation for being the international “gold standard” in regulatory rigor.

 

Unlike its counterparts in other countries, the FDA is believed to be the only drug regulator in the world that consistently receives and reviews patient-level data from the clinical trials that underpin drug and vaccine approvals. To perform such rigorous analyses, the FDA typically spends around 10 months (a mere six months for applications given “priority review” designation) in an effort that involves reviews by experts representing various scientific disciplines: clinical medicine, statistics, pharmacology, chemistry, pharmacovigilance, and more. Together, these reviews form an “action package” which, by law, must be made publicly available 30 days after approval.

 

moar

>https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-pfizer-biontech-vaccine/