Replies to post #273065 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

highwayman4life,

In order for companies to act differently the rules must change. Linda has quite clearly pointed this out in her comments to FDA guidance changes. Dr Pazdur and others will see change when they lead the way forward with rule changes that create the incentive for what they want. The problem is they don't want to step on the hands that feed them too much so there is more imploring than snarling and exposed teeth in this. Best wishes.

[sentiment_stocks]

Excellent, thank you highwayman!

This reminds of my post back from February 13, 2020, regarding pearls falling from Pazdur's mouth. And for those noting that perhaps the FDA is paying attention to NWBO's case, please note that one of our SAB members, John Smyth, was on that same panel with Pazdur.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=153819283&txt2find=Pazdur

Who's mouth did these pearls recently drop from?

“The patient is the client at the FDA.”

“The sciences is changing and should guide our decisions.”

“Are we acting in the best interests of the patient, or are we adhering to regulatory orthodoxy?”

“And when we act in the best interests of patients, we are always right.”

“There are circumstances when a randomized trial does not provide the relevant answers, or may not be the best approach.”

They are from Richard Pazdur, who heads the FDA Oncology Center of Excellence, when he spoke at the recent Cancer Drug Development Forum (CDDF) Spring Conference in the Netherlands, on February 12, 2020, was about “FDA Guidelines” as it pertains to “Regulatory Guidance on Oncology Drug Development”.

Dr. Pazdur's comments are in line with a changing approach at the FDA in approval environment, as has been noted in some of Gottleib and Sharpless' speeches.
This changing FDA approach should help NWBO obtain BLA approval IF there are any issues with the trial's statistical significance.

After he, and others spoke on their respective topics, Dr. Pazdur also participated in a panel discussion with the others that was moderated by one of NWBO’s scientific advisory board members, John Smyth.

[eagle8]

Thank you highwayman4life, great speech of Dr.Pazdur.

I like this part :

It’s a given that effective oncology treatment will involve combinations of drugs.

And we have the platform from were to start.

GLTU