NorthWest Biotherapeutics Inc (NWBO)

[luckyy]

How much time FDA will take to review (if data is positive) 13 years of data ?

Sincere question from a long.

If company and its dedicated team of analysts (inhouse or outsider) has taken almost a year (and still working) to analyze 13 years of test data, how much time FDA will need ?

Even if data is positive and promising, can FDA complete its analysis in max 10 months ? With the pandemic, so many delays have happened already from FDAs side. So, I don't see how any FDA response to NWBO's data comes out before early 2024 at the least.

Is there any similar case where FDA had to review such a huge data of 10+ years and yet was able to give a decision in 10 month window ?

What do you think ?