Thread by @BeauxReliosis

When @TruthCuresLyme met with @US_FDA investigators in Oct 2021, it was a hybrid in-person/virtual meeting conducted on their premises and with their virtual meeting platform. Our attorney and a well-known clinician participated virtually.
#LymeDisease
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We were on premises for 3 hours with 2 investigators & an administrative employee. We were told of only one other FDA employee participating virtually. However, something very telling happened prior to the meeting.
#LymeDisease
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The virtual meeting invitation they sent was rescinded and replaced, causing confusion for our remote representatives. The new invitation included only their names. The old one contained the names of about 10 other FDA employees.
#LymeDisease
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We looked up the names, of course. They are situated at FDA field offices all over the country. So, this is quite suspicious, but there are a lot of things we don’t know.

We don’t know if the people on that original invite listened in.
#LymeDisease #FDA
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We don’t know if other FDA personnel were added to the new invitation.

We don’t know who was the highest ranking official who heard/saw our presentation.

We don’t know why they would include the individuals on the first invite.

#LymeDisease #FDA
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We don’t know if any of this was purely a mistake, e.g. perhaps it’s policy to blind cc internal participants & someone screwed up.

However, we DO know:

One of the investigators transferred to #BARDA within 3 months.

#LymeDisease #FDA
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We’ll call him Investigator A.

Investigator B claimed he was tasked with writing the report, and all responsibility fell on him after Investigator A’s transfer to BARDA.

A is a microbiologist. B is an inspector for an @US_FDA field office.

#LymeDisease
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That left Investigator B way over his head in writing the report on our meeting, from a scientific standpoint.

We also know nobody at @US_FDA is allowed to communicate with us about this meeting. Direct communications are ignored.

#LymeDisease
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The meeting was obtained through our complaint to @US_FDA’s Office of Criminal Investigation. Upon follow-up to OCI, we were told in writing that any information we want about our own meeting must be obtained through #FOIA.

#LymeDisease
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Things we can say about the meeting, in general, off the top of my head:

• They scheduled an hour; we were there for 3 hours.
• They asked very pointed questions to make sure not only they understood the material, but that we understood it.

#LymeDisease
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• They absolutely understood how we came to the conclusions we presented.
• They were mortified by examples we showed of marketing campaigns by #LymeDisease diagnostic test manufacturers.
• False marketing would be a serious violation.

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• We showed slide after slide of 510(k) applications marked up by our independent medical device regulatory expert and they agreed with the critiques.
• We showed them documentation of the process used to clear the #LymeDisease tests implemented post-Dearborn conference.

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• We told them since those tests were not properly cleared (either @US_FDA was duped or complicit), all #LymeDisease tests cleared using those as “predicate devices” must be recalled.
• That would mean every #Lyme test on the market via #FDA clearance would have to go.

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• The @US_FDA investigators in the room agreed with our assessment that those post-Dearborn #LymeDisease tests were improperly cleared.
• We were not allowed to put that fact in the official minutes. That’s why we brought counsel. We anticipated such antics.

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We do not know how many @US_FDA officials were present for the bombshell conclusion that no #LymeDisease #diagnostic test currently on the market has obtained proper clearance, but we must assume word has spread & they are hoping we go away.

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We will not go away. Stay tuned for further action by @TruthCuresLyme to come very soon. Please consider supporting our efforts with a contribution to our 501(c)3 organization dedicated to #justice for #LymeDisease victims.

truthcures.org/donate