Pfizer: Company warns of the damage caused by the release of FDA clinical data
Two weeks ago, the FDA pleaded with a Texas judge to delay production of the first monthly batch of 55,000 pages of Covid-19 vaccine data submitted to the agency by Pfizer. Initially, the agency only had to produce 500 pages per month.
Now, Pfizer, which expects just $ 54 billion in Covid-related sales in 2022, appears to be anticipating some bad news, as evidenced by several changes in the red line in their fourth-quarter earnings releases.
As Rubicon Capital's Kelly Brown notes on Twitter, the changes are centered around disclosing unfavorable security data.
For example, in the fourth quarter they added: “or additional information on the quality of preclinical, clinical or safety data, including by audit or inspection”.
Here are the risks added in the new drafting of the stock exchange information document.
"… risks associated with … additional information on the quality of preclinical, clinical or safety data, including through audit or inspection;"
"… challenges related to public trust or awareness of our COVID-19 or Paxlovid vaccine, including challenges driven by misinformation, access, CLINICAL DATA INTEGRITY CONCERNS, and prescriber and pharmacy training;"
Pfizer added new and peculiar items deep in its business risk disclosures re: clinical trial data, today in its Q4 earnings.
(1/3)
"… Risks associated with… further information regarding the quality of pre-clinical, clinical or safety data, including by audit or inspection;" pic.twitter.com/2GCjs0Bj3r– Kelly Brown (@rubiconcapital_) February 8, 2022
Furthermore, the company warns against the fact that "Covid 19 may disappear or decrease strongly"
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New risk disclosure regarding Covid-19 itself:"… The possibility that COVID-19 will diminish in severity or prevalence, or disappear entirely;" pic.twitter.com/1nOK8fu8HQ
– Kelly Brown (@rubiconcapital_) February 8, 2022
So, stop everyone: on the eve of a verdict that could force the FDA to very quickly distribute all documents related to the Covid-19 Pfizer vaccine, including the results of pre-clinical tests, adverse effects, etc, the company warns investors from the danger that this information could damage corporate profits. So he still warns of the damage that the clinical data disclosed could have caused. Then another threat to Pfizer's profit, that the covid may disappear.
So "Mors tua, vita mea". Why does Pfizer fear that clinical data held by the FDA could harm it? Ah, mystery … ..
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The Pfizer article: the company warns against the damage caused by the dissemination of FDA clinical data comes from ScenariEconomici.it .
This is a machine translation of a post published on Scenari Economici at the URL https://scenarieconomici.it/pfizer-la-societa-mette-in-guarda-dai-danni-portati-dalla-diffusione-dei-dati-clinici-fda/ on Wed, 09 Feb 2022 09:00:20 +0000.