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Re: underpar71 post# 610529

Monday, 07/17/2023 9:56:26 AM

Monday, July 17, 2023 9:56:26 AM

Post# of 705240
I wrote about a month or two ago that one of these excuses detailed below will gain traction as we approach late Q3 with no U.K. submission/acceptance news. Eventually, NWBO will disappoint investors again by announcing only MAA submission/acceptance but it would be almost a year after MIA that its impact will be muted and likely result in another sell the news trigger.

1) The focus has shifted to FDA now? UK not number one priority anymore. So need more time to line up CRL and other million BLA pages?

2) Now applying strategically via Project Orbis. All RAs at once. Need extra months.

3) Flaskworks certification given off label demand considerations!

4) Going after tissue agnostic approvals.

5) No MAA acceptance PR. Need to wait until final MHRA approval (in 2024?) for the big reveal.

6) Rolling review already in the works. Approvals can come anytime.
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