This release doesn't even seem like 55,000 pages to me. Also I don't believe there is an updated "post-marketing experience" document, which seems to be the label they use for examining adverse reactions. The most up-to-date one is from an earlier release and the report is date April 2021. If I'm wrong please someone let me know.
125742_S1_M1_priority-review-request.pdf has some outcomes dates and you can see the alterations. They are controlling for HIV as a factor, which I found interesting. They are not reporting serious adverse events just things like fever and swelling at the site.
It's 2 batches of 10,000, next is due April 1. Then 3 months @ 80,000 pages, 2 months @ 70,000, THEN 55,000 a month after that. It's a cluster fuck. They can literally leave out enough important denominators to obfuscate the total picture for years to come.
This release doesn't even seem like 55,000 pages to me. Also I don't believe there is an updated "post-marketing experience" document, which seems to be the label they use for examining adverse reactions. The most up-to-date one is from an earlier release and the report is date April 2021. If I'm wrong please someone let me know.
125742_S1_M1_priority-review-request.pdf has some outcomes dates and you can see the alterations. They are controlling for HIV as a factor, which I found interesting. They are not reporting serious adverse events just things like fever and swelling at the site.
It's 2 batches of 10,000, next is due April 1. Then 3 months @ 80,000 pages, 2 months @ 70,000, THEN 55,000 a month after that. It's a cluster fuck. They can literally leave out enough important denominators to obfuscate the total picture for years to come.