Declaration of Peter "Pretzel" Marks

The Director of FDA CBER explains how same is different but same

I mentioned this declaration in our discussion with Dr. Meryl Nass on CHD TV on June 16 about the “bait and switch” scheme that the DOD and HHS officials pulled on the American and global public. Video Recording Link Here

There were several questions about BLA vs EUA status of the product. Just to reiterate what we discussed:

• EUA (Emergency Use Authorization) is a mechanism for the FDA to put products on the market without formal safety/efficacy/manufacturing quality review for what is deemed dire situation and emergency. Started as a niche pathway in late 90’s, today this mechanism is being abused by the FDA to put hundreds of untested products on the market. One of the key requirements for issuing an EUA is that there is no approved product to treat the condition.

• BLA (Biologics License Application/Approval) is the full regulatory approval of a pharmaceutical product which is supposed to include all safety, efficacy and manufacturing process review, inspections, quality assurance, etc. The FDA is divided into “drugs” and “biologics” (including vaccines), the distinction being small molecules vs large molecules and things like tissues, cell lines and blood products.

• Importantly, even after the BLA is issued, each lot of the BLA vaccine must be separately tested and approved for release - the “lot release process”.

• The DOD and FDA officials lied about “FDA approved” status of Covid-19 injections. The reason for this lie is that it enables them to use the PREP Act liability shield since the actual distributed and injected substance is the EUA version. At the same time, they are forcing vaccination mandates (impossible with experimental substances), by claiming that the two versions are “the same”. In reality they are not the same (not even chemically, which I will explain in future posts). They admit there is a legal difference between the two versions, but avoid explaining how significant: there are no requirements to test the EUA version for safety, efficacy, manufacturing compliance, and there is no lot-release testing requirement.

Here is what Peter “Pretzel” Marks, Director of CBER at FDA has to say about this. This declaration was filed in the court case where servicemembers are suing Scy of Defense and the DOD for covid vaccination mandates.

The excerpts and my commentary below are based on this glorious court document.

Link to the document here.

From this declaration we learn what the criteria for issuing Covid-19 mRNA “vaccine” “emergency authorization” (EUA) are:

This translates roughly to:

1. Whenever your lords at HHS decided that there is a pandemic (whatever we think that is, peasant, lol, lol).

2. Whatever your lord HHS Scy feels may be effective.

The famous 21 USC 360(bbb) is cited of course. But everyone who has been paying attention on this stack already knows this. That was in the introductory level material.

Now we are moving into the master class territory. Behold Peter “Pretzel” Marks explaining how the “fully approved” and “emergency use authorized” substance can be the same. Abracadabra! This is like the transmutation of lead into gold and Schordinger’s cat, almost simultaneously. It’s like being a little bit pregnant also.

Peter states that the FDA decided the EUA version must remain in circulation along with the “approved” version (which was never shipped in the US according to FOIAed shipping data). It is interesting to note that “small amount” of Comirnaty indeed became available in the US, 35,000 doses to be precise, starting in August 2022. That’s a tiny fraction of one lot (which now can be up to 12 million doses, or even infinity since Pfizer moved to “continuous” manufacturing). Why would they make and ship so little? Why, of course that was necessary to push some military mandate refuseniks in Alaska Coast Guard, and some other places. The article says the pharmacies can now order Comirnaty but no information on whether they can receive these orders. And since that article was written, of course the FDA removed the monovalent vaxes from the market - poof! Let’s forget that happened. Moving on.

Because the FDA determined that 2 versions are absolutely the same…

…but, actually, not the same, because legally different…

… and here Peter Marks “forgets” to mention that the main legal difference between EUA and BLA product is that the EUA-Countermeasure under PHE is deployed solely on the criterion that it “may be effective” (see para 7 above) and no other hard requirements, while BLA requires the full regulatory approval and verification that the manufacturing complies with the federal standards for pharmaceutical products.

He goes into the distinction between BLA and EUA manufacturing sites and lot release requirement for BLA (all true). Then he asserts that both BLA and EUA sites must adhere to the cGMP requirements:

…but forgets to mention that for EUA manufacturing there is no way to verify or ENFORCE the cGMP requirement (for EUA-Countermeasure, only “may be effective” hope and blessing from HHS Scy applies, see para 7 above).

No enforcement means there is no real requirement.

Now comes the main part of the “bait and switch” scheme, pay attention:

You see, on the basis that maybe some of the same manufacturing facilities are used to make a non-existent BLA product and the quite real EUA one the FDA decided that lying to the people by withholding the information that the product they are receiving is EUA and thus cannot be forced on them is totally ok.

Does the FDA have authority to make laws? I don’t think so.

Additionally, Comirnaty received the “Fast Track” designation from the FDA.

Funny he should mention it. Which Comirnaty? There are 4 of them under the same IND (Investigational New Drug) number mentioned in the Fast Track designation letter, and many more were tested in clinical and preclinical studies. So which one is it? Can FDA enforce that version? How would they know which one is being shipped anyway, since the lot release testing does not apply to the EUA variety?

I want to emphasize that 1 IND for 4 different products was never allowed before. since that would make mockery of pharmaceutical regulations and strict “one formula one dossier” requirement. Are there 4 different formulas for aspirin out there (not different dosage or delivery formulation, but different chemical formulas)? I don’t think so. Apparently, this is ok now, in this new clown-infested reality we find ourselves in.

… he again forgets to mention that there are no statutory requirements, stringent or otherwise for EUA-Countermeasures. Only “maybe effective” opinion of whoever happens to be the HHS Scy. He goes into several pages describing all the stringent multi-faceted requirements that apply to other pharmaceutical products, in general.

Just not this one.

Art for today: sketch of sheep in a vineyard, oil on panel, 9x12 in.