Replies to post #708634 on NorthWest Biotherapeutics Inc (NWBO)

[drugrunner]

X you seem to have a problem accepting the fact that they worked with all the regulatory bodies on this change. So you keep wanting to fight a battle that is already been one and pretend like your side of the argument is relevant. Sorry, dude you and all your friends are going to spend a lot of time in jail soon.

[dennisdave]

Good grief. Do you seriously live in your own fantasy bubble?

Sponsors should finalize a study protocol before initiating the externally controlled trial, including selection of the external control arm and analytic approach, rather than selecting an external control arm after the completion of a single-arm trial

NWBO did that. NWBO did submit its trial design before initiating the externally controlled trial. NWBO submitted an IND with a trial design SPA and SAP.
Hilarious that you now claim that NWBO started a medical trial illegally without an approved IND. Are you sure you are an IT guy you really have talent as a stand-up comedian! Then in 2018 unrelated to the IA NWBO amended the SAP, which is completely legal and happens all the time. In there they the ECA protocol was added. Read this if you know how to read

https://www.fda.gov/media/87621/download

If the SAP is changed late in the trial, particularly after the data may be available, it is critical for the sponsor to assure the FDA that anyone making such changes has been unaware of the results. Sponsors should be encouraged to describe the methods used to ensure compliance. Additional information on the principles of statistical analyses of clinical trials is available in ICH E9. 75 The review of the SAP requires close collaboration with the biostatistical reviewer.

That is why Dr Bosch left for The Netherlands and the Merck guy was hired. Bosch was Biased and the Merck guy was not.
Thats is also why you are as dumb as an ignorant ass.

NWBO was exempt from the FDA requirement to include patient level data
https://www.fda.gov/media/171667/download

• If an appropriate justification exists for why a sponsor cannot submit patient-level data to FDA through traditional channels, regulatory pathways exist for third parties to provide patient-level data to FDA to support a sponsor’s marketing application. Specifically, the third-party provider can choose to open either a pre-investigational new drug application (pre-IND) or a Type V drug master file (DMF). The sponsor should provide a letter of authorization from the third party for FDA to reference the data in a third party’s pre-IND or DMF. F

You still have not quoted where the DMC will tip the sponsor off, on the progress of the locked data. DMCs are used all the time by many biotechs in many medical trials. So is IA. Why you are BSing your conspiracy theory that NWBO's DMC and IA tipped of NWBO management without evidence to change study protocol is beyond me other than you being dumb as shit. https://www.fda.gov/media/75398/download

[dennisdave]

You continue to argue it would make trials impossible to stick with this,

I appreciate it you have me at the same quality of posting as the American Brain Tumor Association

An FDA proposal to require the inclusion of patient-level data in marketing applications may prevent the use of external controls for some rare diseases, the American Brain Tumor Association said in their comment. “[I]ndividual patient-level data (IPD) is not always available for many cancers and other rare diseases,” they wrote. “This is due to many barriers that interfere with data sharing in healthcare.”

https://www.raps.org/News-and-Articles/News-Articles/2023/5/Stakeholders-want-more-clarity-from-FDA-on-using-d