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DewDiligence

09/19/22 1:54 PM

#243877 RE: DewDiligence #243487

PFE—Prevnar-20 results in EU infants looks good enough for EU approval:

https://finance.yahoo.com/news/pfizer-announces-positive-top-line-104500704.html

The main difference between these data and the data from PFE’s similar phase-3 trial in the US (#msg-169661718) is the number of shots in the treatment course: 3 in the EU; 4 in the US.

Please see #msg-169661718 for related info.
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DewDiligence

01/06/23 12:14 PM

#244981 RE: DewDiligence #243487

PFE’s Prevnar-20 sBLA for infants/children has Apr-2023 PDUFA date—(with FDA priority review):

https://finance.yahoo.com/news/u-fda-accepts-priority-review-114500941.html

Please see #msg-169661718 for related info.

Prevnar-20 is always FDA approved and ACIP-endorsed for the adult market (#msg-166441188).
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DewDiligence

04/27/23 4:19 PM

#246613 RE: DewDiligence #243487

FDA approves PFE's Prevnar-20 for infants/children:

https://finance.yahoo.com/news/u-fda-approves-prevnar-20-194200076.html

Please see #msg-169661718 for related info.

Prevnar-20 is already FDA-approved and ACIP-endorsed for the adult market (#msg-166441188).