NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

If you are correct, take the established medicines protocol. What are they assessing for up to 150 days?

Well, if they do send out an RFI after the first assessment period, when the clock goes back on, they are only assessing the response. If the response addresses all the issues, then the maa moves to determination. If the assessment of the response finds issues still remain, like “efficacy” or “safety,” then it must go to a CHM hearing.

On the other hand, if an RFI is not issued, it goes straight to “determination,” not further assessment.

So let’s review.

Quick route. 80 days assessment > determination

Slower route. (Up to) 80 days assessment > RFI > clock off (up to) 60 days > response received and further 70 days assessment > determination.

Slowest route.

(Up to) 80 days assessment > RFI > clock off (up to) 60 days > response received and further (up to) 70 days assessment > sent to CHM for advice > further assessment > determination