NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

I believe the FDA guided NWBO that this will be the policy, but the policy is not final, and they likely have been guiding everyone else as to what the policy is. The challenge is that a journal can’t participate in such conference calls that provide direct guidance to companies, and the actual guidance is not yet finished. Other countries have agreed to the SAP, but the SAP is not FDA policy.

Doesn’t mean it is held up, but likely is useful clarification and confirmation that policy is happening and these are the key concerns. For third parties that might evaluate results of a clinical trial based on this updated policy, the FDA’s further clarification would be very useful.