Saturday, May 11, 2024 4:46:40 AM
@peter_brit
#dcvax $nwbo #gbm
I still have not seen anything to suggest that Project Orbis might still not be in play. The company would not necessarily say if it was but interesting that the rapid assessment procedure of 150 day does not rule out Orbis from being in play, just a thought.....
The fact they have not made any "amendment or addition to its MAA after the original 12/20/2023 submission” is the only barrier however to be considered for the Project Orbis pathway it is possible that the following might have applied "Project Orbis Partners (POPs) may propose products for inclusion in the scheme. " so the company statement could still be valid if MHRA proposed the company's inclusion for Orbis pathway.
I am reminded of a conversation a poster had with DI where he stated when he was asked about UK being the first to approve, DI's response was "not necessarily"
Linda Powers is on record as stating that with regards to Marketing Authorization applications that they would be "Strategic"...
https://gov.uk/guidance/guidance-on-project-orbis
https://ih.advfn.com/stock-market/USOTC/northwest-biotherapeutics-qb-NWBO/stock-news/93828655/form-10-q-quarterly-report-sections-13-or-15d
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