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Care Access Compendium

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Quote from Guest on October 11, 2023, 6:48 pm

Especially if they think they are right and haven't been able to say anything about it until the FDA came by...

Quote from Guest on October 11, 2023, 6:30 pm
Quote from brad on October 11, 2023, 6:05 pm
Quote from Guest on October 11, 2023, 4:56 pm

FDA finds no evidence of GCP Violation. 

https://careaccess.com/about/news/2023-10-11-press-release-fda-finds-no-misconduct-by-care-access-in-pfizers-lyme-vaccine-trial

yeah this one is a real melon scratcher. the audit ended yesterday so it seems like they had this primed and ready to publish.

? what would you expect them to do, sit on this for a week then announce it? It's a fairly big deal, and we live in the era of GPT!

 

Fair enough. Still seems weird. So was Pfizer just crazy or did they clean up nice? Is there any way to independently verify that this audit happened and is there anything else we can learn here?

I'm even more confused at this point.

Hightower Clinical / Note to File Podcast / Existential Dilettante / "Specialization is for insects"
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Pfizer needs to speak up and state exactly what their concerns were.

My guess is they won't - why make it a national headline if they don't have to? Right now its only of interest to folk in the research community. 

 

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Quote from Guest on October 11, 2023, 8:17 pm

Pfizer needs to speak up and state exactly what their concerns were.

My guess is they won't - why make it a national headline if they don't have to? Right now its only of interest to folk in the research community. 

 

I'd love to see this but, like you, I sincerely doubt it would happen. The bigger question is why make the specific allegation in the first place?

Hightower Clinical / Note to File Podcast / Existential Dilettante / "Specialization is for insects"
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$$$?!? 

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Something here doesn't make sense, pfizer would try to sweep under the rug anything they can. A bold move like this indicates that the issue should be noticable. But if CA is saying the truth, and nothing was found in the audit, that must mean...

Oh my god...

Yes, it all makes sense now...

All this time, it's actually been Big Tick that pulls the strings in the pharma industry, trying to suppress a vaccine. Remember LYMErix? Of course you don't, tick psy-ops made sure to stop the product and erase it from memory of us - the sheeple. And the tick cabal will keep getting away with this, since we are blind to the truth and unwilling to act.

Well, i say NO MORE! No longer shall Big Tick suck on our blood and get away with it! It's about time we all come together, reverse the roles, and suck on the Big Tick!

Who's with me? Let's all go out in the streets and suck some Tick!

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Quote from Guest on October 14, 2023, 9:19 pm

Something here doesn't make sense, pfizer would try to sweep under the rug anything they can. A bold move like this indicates that the issue should be noticable. But if CA is saying the truth, and nothing was found in the audit, that must mean...

Oh my god...

Yes, it all makes sense now...

All this time, it's actually been Big Tick that pulls the strings in the pharma industry, trying to suppress a vaccine. Remember LYMErix? Of course you don't, tick psy-ops made sure to stop the product and erase it from memory of us - the sheeple. And the tick cabal will keep getting away with this, since we are blind to the truth and unwilling to act.

Well, i say NO MORE! No longer shall Big Tick suck on our blood and get away with it! It's about time we all come together, reverse the roles, and suck on the Big Tick!

Who's with me? Let's all go out in the streets and suck some Tick!

Whenever I wonder whether or not I should just shut this site down, I'm reminded why we need it more than ever: for works of art like this.

Thank you kind stranger. 

Hightower Clinical / Note to File Podcast / Existential Dilettante / "Specialization is for insects"
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Thanks Brad, it's a pleasure to have a place where my shitposts are appreciated.

But seriously, there was a whole lot of non-GCP stuff going on, and work on cleanup started a bit before the whole thing going public, so there was plenty of time to get everything ready. What i can tell you, is that a whole lot of source data ended up as "late entry", because it just couldn't be captured in esource on time due to the mad pacing. That alone should be a significant bit of non-ALCOA-ness, but i guess it's not a big enough of a deal to warrant a 483.

Now if someone could tell us the story about pregnancy tests in this trial, that could be a bit of fun.

But yeah, it was a bit of a shitshow, it got all dolled up for an audit like this. It had no good ending potential if left ongoing.

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