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Re: OncoJock post# 629398

Friday, 09/08/2023 6:28:55 PM

Friday, September 08, 2023 6:28:55 PM

Post# of 724272
OncoJock, you're not doing your job very well if you don't see biotechs PR submission of MA.

Also, FWIW, in my day job of writing about the latest and greatest cancer medicines, it's highly unusual for a company to issue a press release announcing its intention to file a regulatory submission. In my experience, it's far more normal for a company to announce that an application has been accepted by a regulatory authority. Here's why: Just because NW Bio submits the application, doesn't mean the MHRA accepts it. The MHRA may require all kinds of additional info from NW Bio before it deems the application to have been submitted in a full and satisfactory manner. This may easily take a great deal of extra time, which of course no one is including in their timelines for a possible regulatory decision.

Every biotech that I spot checked PR'd submission of their BLA/MAA. Are there small public biotechs that just PR acceptance of Marketing Application? Maybe, but I haven't seen it in my spot checks. I noted other companies PRing the beginning of the Rolling Review process and the submission of the RR process in post 603724 and 606391, and earlier posts where they PR'd submission of the application. Another poster noted another submission PR in post 606027. Regarding, NWBOs PR announcing its intention to file a regulatory submission, many were hoping we'd get a submittal PR per the MHRA submittal timeline (~Aug 28th). So I think the Aug 29th PR was the perfect salve for what ailed longs.
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