That is one of the accelerated statuses that allows for a drug to be in Project Orbis, doesn’t matter which one. Cell therapies and vaccines would be better under RMAT, but they could qualify for any of them including BTD. RMAT is a low hurdle I believe given both the previous data, which is all that is needed, to demonstrate that it would be worthy, not final TLD, though if they are there, in theory a company might wait because it might be moot if the data were not as anticipated (unlikely in this case). The key issue though, for any of the accelerated statuses is that parties are simultaneous to their trials working out the manufacturing issues. That is coming late for DCVax in the sense that they now need it really to be part of Project Orbis and have an accelerated status late in the game. The FDA does not want to accelerate a product that can’t be manufactured fast enough to become the new Standard of Care for the relevant disease. Though if one looks at the earlier Car-T processes, the politics around those drugs seemed to put the manufacturing challenges they faced out of eyeshot for the regulators.
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