Replies to post #774182 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

That explains why the very first thing they was to submit an MAA to the FDA. 🙄🤷‍♀️

[Investor082]

But you were slowly explaining Project Orbis and worldwide regulatory and reimbursement approvals to everyone 4 odd years ago. You kept on pumping for a couple of years. How is that coming along? We are still waiting, LOL!

[manibiotech]

As usual another BS

Here it is :
““this guidance focuses on the use of patient-level data from other clinical trials or from real-world data (RWD) sources, such as registries as well as electronic health records (EHRs) and medical claims.” ”

Page 1 of PDF. Clearly says “other clinical trial as well as RWD sources “

Read it to your hearts content

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-and-conduct-externally-controlled-trials-drug-and-biological-products

Not sure when it will be finalized or if there will be any change to it . But there you have it .

[Hopeforthefuture3]

Again ATL you are not correct.
As the fdatold the cei of mimivax they had to have patient level data for comparison. Liau in one of her talks spoke of controlled studies and how they should (but do not) share the patient level data she said nothing of rwd data only that from controlled studies. Liau also spoke of the eu and UK may be more open to the use of grouped data from other trials. You keep believing as you do even though incorrect
Just like the talks from Dr Liau where she says immunotherapy in gym sees perhaps 20 to 30% response rate and you said all respond. If so why in the 3 ucla spoke grant trials only 1 uses the vaccine

And yes nearly all here know the eca for the nwbo trial was from other controlled trials now rwd