Replies to post #430354 on NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

This isn’t the same guidance that Lykiri wrote FDA about.

The three pharmas were responding to requests from FDA on their “Benefit Risk” guidance put out in September 2021:
https://www.fda.gov/media/152544/download

…and Lykiri’s letter to FDA concerned the “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products” guidance from December 2019 found here (and liked above in the board information - I’ll add the link to the previous Benefit-Risk guidance in the section above later today):
https://www.fda.gov/media/133660/download