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Mar 3, 2022Liked by Modern Discontent

"What’s interesting is the last paragraph, which suggests that no adaptive immune response occurred to target luciferase, although it does appear that an adaptive immune response was formed against the modRNA, and it appears that it depends on the type of LNP used."

You may have already spotted it, but 4.5.9 suggests the T Cell / ELISpot response was elicited with the luciferase peptides. A quick review of the research suggests that ELISpot with luciferase peptides is typically used for testing gene vector platforms that are intended to NOT induce an adaptive immune response - https://www.nature.com/articles/3300951 - so, just like here, it may be a common thing that antibody screening usually misses luciferase sensitization and that is why ELISpot is preferred. (Just guessing since I can't find any specific mention of antibodies in conjunction with luciferase gene platform trials.)

So, it probably didn't add a ton of value to the distribution study. A separate immunogenicity study would still be wanted.

There's a non-redacted summary of R-20-0072 and more good stuff in the Australia nonclinical overview that was released last week-ish (including more "spike in the nucleus?" stains) https://www.tga.gov.au/sites/default/files/foi-2389-06.pdf

Lists the redacted products on p 40

mRNA Luciferase LNP12 - DODMA:Chol: DOPE:PEGcerC16 (40:48:10:2); RNA-EH190611-01c, FSU- 1#029, 79% encapsulation, 0.9053 mg/ ml encapsulated RNA, diameter 84 .nm. polydispersity 0.202, storage temperature +4°C.

mRNA Luciferase LNP5 - Acuitas proprietary; RNA-EHl90611-0lc, batch FM-1055-D, 79% encapsulation, 0.924 mg/ ml encapsulated RNA, diameter 108 nm. polydispersity 0.091, storage temperature -80°C.

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The lack of transparency in data submitted to federal agencies happens at the EPA also. For pesticide approvals, only the active ingredient in the pesticide has to be declared. The active ingredient can be as little as 1% of the whole formula.

There is an urban myth that the government tests everything and nothing unsafe would ever be released on to the market. We all need to dispel that myth. Talk to family and friends and explain why they can't trust any product. Buyer beware!

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Mar 3, 2022Liked by Modern Discontent

Thanks so much for digging into the data! I just read naked emperor too, and I'm excited for the scientist substackers to work together on this data. I have to say it's really fun and so educating to watch you all collaborate. 👍🏼💕

I love your white pill conclusion, that while it's unethical that so much is redacted and cannot really be peer reviewed, hopefully it will get out that this is the way the FDA review process works. You concluded that your brief experience interacting with the FDA means that is the normal way they operate. I imagine that is true, even with your brief anecdotal experience, because it showed what type of person they want on board; someone who is okay skirting the scientific and strict review process.

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