Replies to post #774197 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

dennisdave, the highlighted section (that you posted) of the FDA guidance does not say what you think it says, nor does it say what you are alleging it says. Here is the exact quoted section:

Although various sources of data can serve as the control arm in an externally controlled trial, 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

Again, NWBio did not use patient-level data from other clinical trials, or patient-level data from RWD source databases.

Instead, NWBio used pooled control group data, from other external peer-reviewed and published randomized controlled trials (RCTs), to develop their ECA.

This section of the guidance that you quoted, does not support your opinions.

[Doc logic]

dennisdave,

What you point out comes down to what I have been saying all along about FDA. They use the word “should” to mean suggested or recommended, but not required so technically NWBO’s data could be submitted and be considered fairly apart from what is suggested. The issue is that those who vote on approvals can choose to stand firm on what is suggested or recommended in the guidance especially if incentivized by big pharma influence vs being fair with regard to evidence presented that might validate another form of data interpretation. This level of subjective choice creates opportunity for undue influence. For NWBO that apparently was just not worth the risk. Best wishes.