Evaluate, I appreciate your reply. But, as Lykiri, Dan88 & flipper44 have said and shown, the FDA RTOR started out with only supplemental NDAs & BLAs. But, it was expanded by the FDA to include new NDAs & BLAs for NMEs.
Also, the sponsor & the FDA do not announce a RTOR submission until the new BLA / NDA application has been accepted by the FDA. This step does not happen until all of the new BLA application modules have been completely submitted.
I do not believe that NWBio has gotten this far yet. I believe that NWBio has submitted the DCVax-L top line data (TLD) to the FDA for its initial review, and the FDA has determined that the DCVax-L BLA does qualify for the FDA RTOR program, and it can be moved to the next steps in the process.
I think that is part of the reason NWBio got the loan for $11 million, was so that it hire outside experts to help them finish all the required modules to complete the new BLA, and submit it to all of the 4 regulatory authorities.
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