Doc Logic, though I would say what you mention seems quite optimistic, it is not impossible. We do not know enough about the details of their process nor what exactly was changed. When they say the enclosed the system or they implemented TFF, it is possible they may have also made other minor enhancements. Just closing the system or implementing TFF would not typically result in a more effective product, but, we do not know what would have to be changed to produce more effective product without detailed process knowledge. So, if there was an unexpected product improvement that resulted from the process changes, NWBO would have to prove the product is still the same, just higher potency or ... And, as you can imagine, the regulatory bodies have to be convinced that the product is still the same product, just enhanced in a definable, controllable and characterizable way. If there is a process enhancement that has resulted in improved therapeutic efficacy without 'changing' the product that could result in a very interesting clinical data situation. Even if the enhancement was not foreseen in the plant, the result in the clinic should have been expected. Assuming so, there would not be a time consuming investigation. But, if the enhanced therapeutic effect was not expected, that could certainly lead to a time consuming investigation to uncover the reason why some patients, maybe across phenotypes, were showing improved clinical results. I feel like we may be going beyond reality here, but, then again why not.
