Replies to post #705976 on NorthWest Biotherapeutics Inc (NWBO)

[iclight]

Hoping the company’s bullshit redo of the trial gets around the FDAs REQUIREMENT of patient level data for the ECA isn’t just wishful thinking, it’s absurdity.

Medicenna got ACTUAL APPROVAL for their hybrid ECA (which includes a database with all patient level data) from the FDA because they actual met with the FDA after their P2 to confirm they could use an ECA. Do you think they would’ve chosen the more time-consuming and expensive route they chose with patient level data if the FDA didn’t require it? They would’ve done the same bullshit that NWBO.

But hey, that’s exactly why they didn’t submit to the FDA and submitted to the practically irrelevant MHRA.

[dennisdave]

Yes, the external control arms do not have patient level data

which is not required in the sense what exwan meant and what you justifiably said competing companies did not deliver to NWBO

During the submission process, researchers will need to show the patient-level data used to create their ECA along with the corresponding data from the investigational arm. 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.

NWBO did adhere to this requirement. So in other words there is a misunderstanding here of what patient-level data means. If we take the cotahealthcare article definition then NWBO DID meet that requirement.

https://cotahealthcare.com/building-a-better-eca-5-steps-for-submitting-an-eca-to-regulators/

[dennisdave]

you are confusing everyone here by taking the bashers Exwannebe and icylights definition of patient-level data seriously Senti.

Yes, the external control arms do not have patient level data.

Yes NWBO did meet the patient level data requirement