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DavidW2

10/12/24 3:57 PM

#725743 RE: meirluc #725739

I really feel disappointed if what you say is true....It also proves approval won't come until year 2025 and no news from the company during interim.
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flipper44

10/12/24 4:02 PM

#725744 RE: meirluc #725739

I don’t think so. They are very small combo trials, and the blinded/unblinded one is also sponsored by Merck and was unblinded to investigators back on September 11. I doubt it will take anywhere near as long as you’re thinking to give MHRA a preliminary final analysis. If the MHRA wants to see them.
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scotty3371

10/12/24 4:35 PM

#725751 RE: meirluc #725739

We are going to December regardless.......
Bullish
Bullish
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Sammy 967

10/12/24 8:21 PM

#725779 RE: meirluc #725739

It has nothing to do with our approval. Completely irrelevant
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mike00h

10/12/24 9:45 PM

#725785 RE: meirluc #725739

Bureaucratic delays, my personal story.

Hot sure how relevant it is but the US IRS experienced a colossal delay from Covid in 2020 and 2021. Personally, they messed my return up so badly that I ultimately had to get my congress(wo)man to intervene. Their backlog was 200+ days. Sounds like MHRA had shrunk their Covid delay/backlog down to 47 days when NWBO filed for approval last December. Anyway, after acceptance, it looks like 150 calendar day clock started in March.
As a cya, or to burn some of the Covid backlog, someone at MAA may have inflated some minor quibble into a RFI. However, it's not necessarily true that they added a full 70 days which would burn past the middle of October.


I'm calling the NWBO approval by MHRA/MAA before USA Halloween. Look here for the last half of September and the two halves of October:
https://www.gov.uk/government/publications/marketing-authorisations-granted-in-2024

Technically this means that the announcement may lag (the second half of Oct being announced in mid November...) and not appear before Halloween. My claim is that the approval will appear on or before the second half of October in the link, above.
Bullish
Bullish