Replies to post #585488 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

False.

Provenge

November 13, 2006 was first BLA submission.

April 29, 2010 was the approval.

Provenge days from BLA filing till approval: 1,263 days

^^ That doesn't even include the days from data lock to BLA submission.

Your timelines are misleading, at best.

https://www.drugs.com/history/provenge.html

[dstock07734]

EX,

"I wanted as much to initiate a cancer immune response as I wanted to initiate one against infection."

This is what Dr. Steinman would love to see. Now NWBO has made his dream a reality. Dr. Liau said that in combo trial the immune response from patients was so drastic that patients had to go through surgery.

It is good news for all the investors.

[Arby2000]

They tried to get approved based on a P2 that failed the primary endpoint of PFS but was stat sig on the secondary endpoint of OS. The FDA said that is no good and they needed a real P3 trial that properly defined the prospective OS endpoint in advance.

I think there have been a few changes in FDA's thinking since 2009.