Replies to post #564130 on NorthWest Biotherapeutics Inc (NWBO)

[Smitty5150]

but the US FDA is so corrupted with big pharma money , it may never be de risked

I dont agree. I know its popular for retail investors to think the whole of the FDA is littered with corruption, but that is simply not true. Show me a industry where there is zero corruption and I will say the industry doesn't exist, at least not in this universe. While there are those that are corrupt, its a very, very small minority within the FDA. The outcome of DCVax with the US FDA will be approval.

I know people inside the Agency that are good people, who are sincere and honest. They want to bring drugs to market that benefit patients and their family's. One person I know well works in the FDA's Oncology Center of Excellence in a very high position of influence within the OCE. She might be the most honest person I know. and very well respected. Most of these people have been effected by cancer in one way or another. Either from a Family Member who had cancer, or they are a Oncology Surgeon who has seen first hand the suffering of Cancer Patients. These are not bad people, as you suggest.

Question: Do you know anyone who reviews the BLAs inside the FDA? Or maybe the Independent Advisory Panel the FDA calls on for further validation of BLA approval or not?

If you do not, and have not seen what goes into the drug approval process, I think you need to rethink your comments. Its not the FDA Commissioner that gets a gavel and says yes or no. So many people have ZERO idea how all this works. Most people are professionals and very honest and loaded with integrity.

Another question: Did you see the guidance from the FDA today on the use of External Controls for cancer trials? This should put to bed any and all discussions about NW using ECs in the PH3 DCVax trial, and whether the FDA would accept the practice or not. After all, Dr. LL stated the FDA demanded it. Today was a huge day, but yet I see the same posters making the same stupid (and wrong) arguments rather than focusing on what the FDA is "telling us". Its unreal and shows the inexperience of retail investors when it comes to biotech investing. I mean no disrespect whatsoever when I say this. Its just an observation.

Conspiracy theories aside: DCVax will easily be approved by the US FDA once BLA is submitted.

[dmb2]

extrooper, agreed quite de-risked in UK from the receipt of their prestigious award years ago through to current JAMA article. FDA is another story that I find hard to assess but do believe the science will win and there is no reason to believe FDA will refuse a priority review for such a lethal disease. What I am concerned about is how long it will take NWBO to wrap up their MAA/NDA submissions and who they have on board who will provide final review. I am hopeful given the length of time they have had that they have well prepared their submissions and are close to submitting.

GLTA