At least both sides stipulate we can believe all (or perhaps most) of what management says - the only real debate on that topic is whether this situation is reasonable and justified by necessity or not.
The lack of formal FDA guidance and delay is a real and foreseeable issue. Regulators often times move slow as molasses.
I am certain that NWBO’s regulatory counsel has made NWBO management well aware of this and a possible issue wrt a US journal willing to publish upon condition and when formal guidelines issue from the FDA wrt ECAs.
Accordingly, in an abundance of caution, I believe that in order to avoid this possible issue and hold up, NWBO in collaboration with the authors and strong support from Dr Ashkans opted to go with a UK journal. JMHO.
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