1.) FDA Submission -Unlikely: I would assume NWBO would wait until Flaskworks is approved, and another CDMO in the US is contracted out for capacity concerns. Also, no word from NWBO other than the MHRA submission.
2.) Compassionate Use -Possible: Internal "buzz" on DCVax-L within the medical field and the FDA's interest is peaked.
3.) Charity/Medical Activism -Possible: Non-Profits and charities pushing the envelope to get the regulators attention.
4.) None of the above -Probable: We unfortunately won't know until we know.