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Tuesday, October 04, 2022 5:15:29 PM
Perhaps these companies do not think that the submission of an application is a material matter, but rather the acceptance of the submission is, as you note.
There are, however, also examples of companies that do PR the submission.
Below are a few companies that I found who PR'd their MHRA MAA submissions:
March 2, 2021 - submit MAA
May 12, 2021 - approval granted
BioCryst Submits Marketing Authorization Application for UK Approval of ORLADEYO™ (berotralstat), an Oral, Once-daily Therapy to Prevent Attacks in Patients with Hereditary Angioedema
https://ir.biocryst.com/news-releases/news-release-details/biocryst-submits-marketing-authorization-application-uk-approval
January 12, 2021 - submit MAA
February 7, 2021 - approval granted
CHRONOCORT® MARKETING AUTHORISATION APPLICATION SUBMITTED TO THE UK MHRA
https://www.diurnal.com/Investor/news/chronocort-r-marketing-authorisation-application-submitted-to-the-uk-mhra
And here are a few companies that PR'd their FDA BLA submissions:
July 8, 2020 - submit BLA to FDA
June 7, 2021 - receives AA from FDA
Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease
https://investors.biogen.com/news-releases/news-release-details/biogen-completes-submission-biologics-license-application-fda
May 7, 2021 - initiating submission process
August 23, 2021 - FDA approval
Pfizer-BioNTech Applying for FDA BLA for Their COVID-19 Vaccine
https://www.contagionlive.com/view/health-officials-urge-flu-vaccination-but-few-adults-plan-to-get-the-shot
September 21, 2021 - submits BLA to FDA
August 17, 2022 - FDA approval
bluebird bio Submits Biologics License Application (BLA) to FDA for betibeglogene autotemcel (beti-cel) Gene Therapy for Patients With ß-thalassemia Who Require Regular Red Blood Cell Transfusions
https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-submits-biologics-license-application-bla-fda
Anyhow, in the post I'd responded to, flipper asked if there were "any reason at all to believe the MAA wasn't filed in late August", to which I simply replied that I believe the company considers an MHRA MAA filing to be a material event and so would PR its submission upon submission.
I think that my suggested consideration falls under the answer of "any reason at all", IMO. For now, we can't know if my answer is correct, of course, so we'll have to wait to see if my answer is proven out.
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