Replies to post #273001 on NorthWest Biotherapeutics Inc (NWBO)

[Survivor2012]

Thanks iwasadiver!! I Agree -- time to get it across the finish line!!

[Umibe5690]

You can take that to the bank. The FDA/Hahn and Pazdur are on board. They understand the new immunological paradigm. The FDA guidelines have been written with a lot of carefully thought input from NWBO. There has been discussion about P-values and their application. However, they don't necessarily apply when everyone is living longer including late vaccination. Linda's letter is on point wrt to P-values and sub-groups This is an important area and has been addressed extensively in the SAP on which the FDA has made comments. BTW, would not doubt that several of the 800 statisticians were involved with NWBO. JMHO.

[Hspooner]

iwasadiver, do you think its just a coincidence that our two Linda's both come out talking about the need for change at the FDA with TLD imminent?

https://www.regulations.gov/document?D=FDA-2019-D-4964-0065

https://billmalloy.info/qa-with-linda-liau/

[manibiotech]

That is a wishful thinking based on pure fantasy . FDA making a paradigm shift to help a microcap, pennystock company .
We will see ..

[Doc logic]

iwasadiver,

Agreed. I Just think Linda is pleading with FDA to make even more changes objective instead of subjective where a case by case situation can give opportunity to bias and influence from outside sources not necessarily primarily tied to patient advocacy and well being but rather to purse strings. Patients and doctors want safe options which act as tools with which to work. FDA and other regulators are being asked to take this under full consideration especially where "safety is not an issue". I think that is where anyone who needs treatment, doctors and even the 800 statisticians Linda pointed to, would agree that this type of stance is long overdue and worth pleading for. Best wishes.