Replies to post #546737 on NorthWest Biotherapeutics Inc (NWBO)

[dr_lowenstein]

But more importantly the sap said otherwise and oh boy those stat people are so precise

[biosectinvestor]

Exactly right SkyL. It's an important point that critics fail to realize is important for legal and procedural reasons as well as for reasons relating to an agency acting rationally. They have to act minimally rationally. The FDA required an arrangement that, if the drug is perceived to have worked, of course every patient would want to cross over. It's also a rare disease and they knew that as well and designated this an orphan drug. It would make no sense therefore, at the end of the day to say, we reject your trial results because you had a crossover arm and therefore had no placebo. at a minimum level of rationality, which is a requirement for agencies and government, they need to provide a rational option that addresses the conundrum that the FDA created with their requirement. It also was something said to be an ethical requirement.

So at the end of the day, it appears to me likely that the FDA did in fact direct the company toward the option of an ECA. Now doctors can do what they want on these committees, but if there is no significant risk or danger or significant side effects, and if they demonstrated a significant survival benefit not just for nGBM, but significantly for rGBM and various arms and segments in the trial that normally would have had a much worse prognosis, then it is hard for them to then reject the application for marketing, in my opinion. It's just a regular person's opinion, but I do believe that the FDA has a narrow road to travel given the circumstances that they created as well as given the outcome that is shown with the data.

It is an important point to keep in mind that Liau has specifically stated that FDA mandated crossover for trial participants suffering from GBM. Most recently, she confirmed it during the JAMA interview that Dr. Low published here on iHub—I was so happy to hear her confirm this fact again … brain surgeons are always so precise and accurate it seems, and we need that kind of clarity amid all the noise.

Skip to timestamp 8:01. Dr. Liau again confirms that the crossover was mandated by the FDA.
https://edhub.ama-assn.org/jn-learning/audio-player/18738384