Post AAfBtHaTKk1AzAM3Zg by watch4thedrop@social.quodverum.com
(DIR) More posts by watch4thedrop@social.quodverum.com
(DIR) Post #AAf9KBD0rAEj9xW2Xg by EarlThePearls@social.quodverum.com
2021-08-24T21:31:25Z
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@bonkster @MCMINA #LinksForTheLazy Please
(DIR) Post #AAf9QS4z2rx1DhkcXA by FreakinChickenLittle@social.quodverum.com
2021-08-24T21:32:33Z
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@EarlThePearls @bonkster @MCMINA https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
(DIR) Post #AAf9dba12A24RxXPYO by EarlThePearls@social.quodverum.com
2021-08-24T21:34:55Z
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@FreakinChickenLittle @bonkster @MCMINA ...The EUA is Sufficient...
(DIR) Post #AAf9tasjOgq0uyuqoK by EarlThePearls@social.quodverum.com
2021-08-24T21:37:49Z
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@FreakinChickenLittle @bonkster @MCMINA But is a letter to a company sufficient?Doesn't it need to be published in the Federal Register or Something?#How_Does_It_Work
(DIR) Post #AAfA6es1sXZ33MojAm by watch4thedrop@social.quodverum.com
2021-08-24T21:40:11Z
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@bonkster @EarlThePearls @MCMINA Even without a link, does anybody really believe that the FDA would announce it's official approval and not actually approve it? Dumb conspiracy.
(DIR) Post #AAfAJ3md4xAfnJCm1I by EarlThePearls@social.quodverum.com
2021-08-24T21:42:25Z
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@watch4thedrop Read it and then tell me where they OFFICIALLY APPROVED IThttps://www.fda.gov/media/150386/downloadEUA@bonkster @MCMINA
(DIR) Post #AAfAmyWpBHjmBT4qQK by umad80@social.quodverum.com
2021-08-24T21:47:50Z
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@EarlThePearls @watch4thedrop @bonkster @MCMINA Doesn't page 2 say this? They got the BLA approved but are also keeping the EUA.That's how I read it.
(DIR) Post #AAfAwzQagwjprxw8QK by watch4thedrop@social.quodverum.com
2021-08-24T21:49:39Z
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@umad80 @EarlThePearls @bonkster @MCMINA The fda commissioner literally came out and announced it is approved in an official statement. The rest is just technicalities and logistics.
(DIR) Post #AAfB06eQIDTp8ktPHM by FreakinChickenLittle@social.quodverum.com
2021-08-24T21:50:11Z
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@EarlThePearls @bonkster @MCMINA The EUA includes children 12-15, and third dose for immunocompromised individuals.
(DIR) Post #AAfBFitoMwxS6nXMem by umad80@social.quodverum.com
2021-08-24T21:52:41Z
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@watch4thedrop @EarlThePearls @bonkster @MCMINA That's what I figured. It seems people are misunderstanding the jargon they have to use and acting like it's not approved.But just looking at page 2 should put everything to rest, or am I misreading that?
(DIR) Post #AAfBnVlPiG3LDQijvU by FreakinChickenLittle@social.quodverum.com
2021-08-24T21:59:08Z
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@EarlThePearls @bonkster @MCMINA FDA response to Biologics License Application (BLA) for COMIRNATYhttps://www.fda.gov/media/151710/download
(DIR) Post #AAfBtHaTKk1AzAM3Zg by watch4thedrop@social.quodverum.com
2021-08-24T22:00:10Z
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@umad80 @EarlThePearls @bonkster Yeah. it's a whole bunch of logistics talking about what to do with the indication on the EUA and how to transfer it over, expiration dates of the vials created during the EUA, etc. etc. Good info to know for healthcare professionals but for the layman, all you need to know is this statement
(DIR) Post #AAfBwsf7whFCqBFQI4 by FreakinChickenLittle@social.quodverum.com
2021-08-24T22:00:49Z
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@EarlThePearls @bonkster @MCMINA FDA response to Biologics License Application (BLA) for COMIRNATYhttps://www.fda.gov/media/151710/download#How_Does_It_Work
(DIR) Post #AAfJ625KysNGLloo88 by EarlThePearls@social.quodverum.com
2021-08-24T23:20:55Z
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@watch4thedrop @umad80 @bonkster Show me to the official approval locationThe following is just a press releasehttps://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
(DIR) Post #AAfJL4SGS6UY2liHGC by EarlThePearls@social.quodverum.com
2021-08-24T23:23:38Z
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@bonkster @watch4thedrop PAGE TWELVEThis product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
(DIR) Post #AAfJPR6gAvFVSIhMjx by EarlThePearls@social.quodverum.com
2021-08-24T23:24:25Z
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@bonksterIf you already found it it is only polite to share it"• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner." @watch4thedrop @umad80
(DIR) Post #AAfJiUreQdYGbyl3Q0 by watch4thedrop@social.quodverum.com
2021-08-24T23:27:52Z
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@EarlThePearls @umad80 @bonkster https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
(DIR) Post #AAfK0TkRJlISMUxXTk by watch4thedrop@social.quodverum.com
2021-08-24T23:31:07Z
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@bonkster @EarlThePearls @umad80 BLA approval letter. damn earl you making me do WAY too much work here 😅 https://www.fda.gov/media/151710/download
(DIR) Post #AAfKMBa1XwjcNyRE7E by EarlThePearls@social.quodverum.com
2021-08-24T23:35:02Z
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@bonkster https://www.youtube.com/watch?v=OjYoNL4g5Vg@watch4thedrop posted a link to the official letter, not a press announcementhttps://www.fda.gov/media/151710/download@umad80
(DIR) Post #AAfLasQX8hTtHVZHyy by EarlThePearls@social.quodverum.com
2021-08-24T23:48:54Z
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@watch4thedrop I am persistent once I get started on somethingYou contributions are much appreciatedNo why couldn't the FDA link that in their announcements? Or the the "news" organizationsGoogle useless too@bonkster @umad80
(DIR) Post #AAfLo6Fv2GDhw2uOHY by umad80@social.quodverum.com
2021-08-24T23:51:17Z
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@EarlThePearls @watch4thedrop @bonkster They probably didn't realize people would do this. I mean, who thinks crazy and that the FDA, Pfizer, and a whole host of other people would just up and lie about approval?Most of us don't think like anti-vaxxers, apparently.
(DIR) Post #AAfMCGwEyA9u16ELDs by watch4thedrop@social.quodverum.com
2021-08-24T23:55:39Z
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@umad80 @EarlThePearls @bonkster yup. they usually dont link the approvals when they announce a drugs been approved in the press conferences. for any other drug, no one would give a shit to look
(DIR) Post #AAg3g6spDMHJY26h1c by MEMA@social.quodverum.com
2021-08-25T08:02:51Z
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@watch4thedrop @umad80 @EarlThePearls @bonkster Unfortunately there are a number of underlying causes for irrational fear when someone refuses to accept facts as reality... imo the most ignorant is saving face...
(DIR) Post #AAgpZ7BIVIysFETfFY by Debradelai@social.quodverum.com
2021-08-25T16:59:26Z
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@EarlThePearls @watch4thedrop @bonkster @umad80 They did.
(DIR) Post #AAgsCusJsQJlZNhufw by EarlThePearls@social.quodverum.com
2021-08-25T17:29:01Z
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@Debradelai Show me.My eye was blind to them when I looked@watch4thedrop @bonkster @umad80
(DIR) Post #AAgsTjPJlbqqvT9ym8 by Debradelai@social.quodverum.com
2021-08-25T17:32:04Z
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@EarlThePearls @watch4thedrop @bonkster @umad80 I posted it.It took me 10 seconds to find in in Google.Take the blinders off and you'll see it, too.
(DIR) Post #AAgt5KvVEbdU0J9648 by watch4thedrop@social.quodverum.com
2021-08-25T17:38:52Z
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@Debradelai @EarlThePearls @bonkster @umad80 You know, I double checked the press conference link earl posted. The official approval letter is not on it. but the first link that i posted to the official approval letter is all the way at the bottom. FWIW 🤷♂️
(DIR) Post #AAguWId7yqRqeeyJEm by Donjanusgjrdrm@social.quodverum.com
2021-08-25T17:54:58Z
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@watch4thedrop @Debradelai @EarlThePearls @bonkster @umad80 I am going to have to defer this to lisa our resident researcher and developer. I have no legalese.any lawyers here?
(DIR) Post #AAh4XVyQqzQds29fAO by EarlThePearls@social.quodverum.com
2021-08-25T19:47:14Z
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@Donjanusgjrdrm @watch4thedrop @Debradelai @bonkster @umad80 After a long scroll I found this toothttps://social.quodverum.com/web/statuses/106806526206552588
(DIR) Post #AAh4btYH8I7i9g0c9w by EarlThePearls@social.quodverum.com
2021-08-25T19:48:01Z
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@Donjanusgjrdrm @watch4thedrop @Debradelai @bonkster @umad80 It linked me to thishttps://www.livescience.com/amp/fda-grants-full-approval-pfizer-biontech-covid-vaccine.html
(DIR) Post #AAh4lDg3fxmpBC5zXM by EarlThePearls@social.quodverum.com
2021-08-25T19:49:42Z
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@Donjanusgjrdrm @watch4thedrop @Debradelai @bonkster @umad80 which led to this press releasehttps://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
(DIR) Post #AAh4p92oqJNZy9c6Fc by EarlThePearls@social.quodverum.com
2021-08-25T19:50:25Z
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@Donjanusgjrdrm @watch4thedrop @Debradelai @bonkster @umad80 Which led to thishttps://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
(DIR) Post #AAh4xVjcMfOuetcasS by EarlThePearls@social.quodverum.com
2021-08-25T19:51:56Z
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@Donjanusgjrdrm @watch4thedrop @Debradelai @bonkster @umad80 Which finally led to the approval letter and numerous other useful linkshttps://www.fda.gov/media/151710/download
(DIR) Post #AAh59A96SQmpB168q8 by EarlThePearls@social.quodverum.com
2021-08-25T19:54:02Z
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@Donjanusgjrdrm @watch4thedrop @Debradelai @bonkster @umad80 Not a straight path at allTo further confuse folks have some sciencehttps://www.fda.gov/media/151733/download
(DIR) Post #AAh5L4jSPYNBrTmaxs by EarlThePearls@social.quodverum.com
2021-08-25T19:56:11Z
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@Donjanusgjrdrm @watch4thedrop @Debradelai @bonkster @umad80 A little bit more detail than "Because I said so"Being not FDA Literate I am sure there must be something else they need to do to make it legalI have not chased down all of the links and referencs
(DIR) Post #AAh5W8h21c2fKbvLQO by EarlThePearls@social.quodverum.com
2021-08-25T19:58:11Z
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@Donjanusgjrdrm @watch4thedrop @Debradelai @bonkster @umad80 @barrsniffsatjejuneanalysis might find this interestinghttps://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
(DIR) Post #AAh5bcBZncu2FVp1bE by EarlThePearls@social.quodverum.com
2021-08-25T19:59:10Z
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@bonkster 😤 @Donjanusgjrdrm @watch4thedrop @Debradelai @umad80
(DIR) Post #AAh5rRQ1bALxUP7uoi by barrsniffsatjejuneanalysis@social.quodverum.com
2021-08-25T20:02:02Z
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@EarlThePearls @Donjanusgjrdrm @Debradelai @bonkster @umad80 Thanks, Earl. I do. Drop does not want me tagged to anything related to him. I do not want to be tagged likewise. Please remove me from chain. Best, L
(DIR) Post #AAh6H1J7IpCW2G5nF2 by EarlThePearls@social.quodverum.com
2021-08-25T20:06:38Z
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@bonkster That's why they invented the Pin@Donjanusgjrdrm @watch4thedrop @Debradelai @umad80
(DIR) Post #AAh6lYZCD3qlsJArcO by Donjanusgjrdrm@social.quodverum.com
2021-08-25T20:12:10Z
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@EarlThePearls @bonkster @watch4thedrop @Debradelai @umad80 Are you talking to me?loops do get confusing.
(DIR) Post #AAh7BxaXnmbb0XOYUa by EarlThePearls@social.quodverum.com
2021-08-25T20:16:57Z
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@bonkster It is is directed at the Intelligent Equine above the sentence when I post like this 🤡 @Donjanusgjrdrm @watch4thedrop @Debradelai @umad80
(DIR) Post #AAh7VldVwudZjMEGbw by EarlThePearls@social.quodverum.com
2021-08-25T20:20:31Z
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@bonkster I usually find things easily and this one was evading meAnd it takes so little conscious effort to run down a link tree that it is very easy to forget where one saw something@Donjanusgjrdrm @watch4thedrop @Debradelai @umad80