So I took the time to read, thoroughly, the links I provided and I must conclude the only point I am unsure about are the in vivo tests. In the 2017 ASCO video Lohr talks a lot about this subject, however, the MCB was created later. Still, we know they exchanged the bovine serum with a compliant medium and selected the cells that are identical with the best performance. Question is, if logically that ensures greater safety, would that be enough to guarantee also a practical greater safety? (Wolfy, what is your opinion?)
My guess is an in vivo study started as soon as the cell line was "purified" and we will have a pr about it at some point. Exactly like we have been getting these other prs about studies we had no clue about.
Overall, I think we have much more to offer in regard of tests, studies and additional information than required in the guidelines. The only factor remaining is the pace with which the documentation after the encapsulation and the corresponding tests will be generated.
As per the presentation, we will have to complete another phase 3 trial (or two if I got that right) before the product can be marketed. However, there is fast track and, forgot the name, other possibilities. And the "right to try".
I wouldn't worry about what comes after the 2b because after all improvements that have been done in the last 20 years...I mean this is going to be a fantastic chance at life for all participants in the trial.
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