Replies to post #705979 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

iclight,

No, patient level data is not “required”. That is a lie which I would normally call a misstatement but by now, after so many corrections, we all know better. Go back and reread the guidance then try again; ). Best wishes.

[dennisdave]

It’s literally required for an ECA per the FDA. That’s been posted here numerous times. But that’s your problem since I assume you own shares of this POS.

Lies Lies lies its nor required by the FDA to provide Patient level data as claimed by exwannebe such as treatment history, age, gender etc etc.

But go ahead shortie show me the FDA regulation which stipulates that when ECA compassion is made it's required to provide that kind of information.
Tick tock Tick tock Tick tock crickets

For anyone all other normal thinking posters here reading this. The FDA required that the ECA data is NOT cherry-picked (logically). In the case of the DCVAX ECA comparison, the ECA data was general SOC treatment for nGBM patients which was of course not cherry-picked.
https://cotahealthcare.com/building-a-better-eca-5-steps-for-submitting-an-eca-to-regulators/

In a similar vein, researchers will need to consider questions about the role of an ECA at the very beginning of the project planning process, since tacking on an ECA after analysis of the outcomes is frowned upon by regulators to avoid bias in choosing ad-hoc methods for analysis (e.g. cherry picking select patient populations to favor the treatment effect).

The patient-level data the FDA required what is used to create their ECA along with the corresponding data from the investigational arm. That is as I said generally known information with nGBM SOC.

The Clinical Data Interchange Standards Consortium’s (CDISC’s) Study Data Tabulation Model (SDTM) is typically used for data submitted to the regulatory agencies, but sponsors may wish to discuss other appropriate data standards and current requirements with the review division, if necessary