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Re: thermo post# 536140

Sunday, 11/20/2022 10:21:41 PM

Sunday, November 20, 2022 10:21:41 PM

Post# of 707432
GOOD QUESTION

1. Company press release announcing MHRA has granted approval/certification for commercial manufacturing operations at plant in Sawston before end of this year
2. Company press release announcing MHRA has accepted its application for marketing authorization for DCVax-L, 1Q 2023
3. Announcement (from company, MHRA, or both) that marketing authorization has been granted and some indication whether DCVax-L will be added to standard formulary and reimbursed for patients of the NHS in the UK, also with dosage and pricing information, 2 or 3 Q 2023
4. Company press release announcing that commercial sales have begun, with some indication of initial sales volume, order volume, order backlog, or all three, 3 or 4 Q 2023

5. Total blue sky/wild card/hopeful contingency for which I have no evidence at all and I have no idea when it could happen (but ATLinsider has been talking about this possibility for months if not years and it makes total sense given recent public statements by Richard Pazdur MD about Project Orbis):
FDA announcement of simultaneous approval of DCVax-L in recurrent GBM across at least 2 jurisdictions (USA and UK) and perhaps 3,4, or 5 (European Union, Canada, Japan) etc.
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