Replies to post #810066 on NorthWest Biotherapeutics Inc (NWBO)

[seekinganswers]

"Very clever manipulation, but FDA wouldn't buy it."

Apparently not MHRA either

[learningcurve2020]

I’ve always thought she delayed the MAA submittal until the MHRA broke loose from EMA, probably because they wouldn’t allow them to file either?

[theorysuit]

NWBO knew they were toast at Dr. Liau's Interim analysis when there was no set of PFS results that showed they would meet their primary endpoint. So they had to spin the protocol, endpoints, comparator, add the R/R that wasn't even part of the original protocol.

This 100%. That's why they have 2 or 3 paid trolls that try and reply/refute to all your posts. Thats why they went to the only regulator that wouldn't outright refuse them on the spot. Not approvable by any regulatory agency in the world. The company needs to report on the rejection result sooner rather than later.....it is 2 plus years already. That should be writing on wall for those that have any brain. There is no way that this company can justify this any longer. But it is nwbo so .....

[dstock07734]

How many years have you been repeating this type of nonsense? Five years?

Read carefully the following part from ASM transcript, go through all the new guidance from FDA about rare disease, and ask yourself the question:

Should Dr. Vinay Prasad and Dr. Makary be amazed by the intensity of anti-tumor immune response triggered by DCVax-L in treating the hardest cancer?

Another example has been multiple regulators, including US FDA, including just very recently, coming out with new and modernized policies to embrace and start increasing the use of real-world data and real-world evidence. We’ve treated, for example, hundreds of compassionate use patients, and that real-world data is increasingly valuable as the policies move in the direction of embracing and supporting use of that data in regulatory decision making processes.