NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Certainly, they won’t likely reference new or old definitions. There is only the definition. They need to be prepared to answer questions if the FDA asks them about it, whether they bring it up in anticipation or not. If the FDA asks them, it is entirely fair to do so. And if they anticipate the question with details, that is fine as well. Their counsel and advisors will discuss with them the best approach in terms of whether to anticipate questions or as to how best to address the inevitable question with the FDA.

And, as you suggest, the BLA process may necessitate a particular approach initially.