Replies to post #406186 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Anders, it’s both. There will always be regulators and clinicians that need more education, but I’d surmise there is already “buy in” from the lion’s share of regulators and clinicians working closely on this orphan designated trial.

I only see positives here — not reasons for more delay.

[biosectinvestor]

The FDA updated its guidance to make the conversation possible and in accordance with the 21st Century Cures Act as well.

NWBO commented on the update when it was in early proposal mode and that took about 1 year at the FDA.

The update to SAP followed that change.

However, some changes and some decisions by regulators can cause controversy and regulators do not like to be controversial.

Linda Liau’s thought leadership lectures on the subject last winter and spring at various universities and research centers was a part of that effort to socialize the discussion and the article and lectures including by staff at the FDA are further indications that the message is not only being socialized but well received and amplified by other researchers as a positive development.

This would give regulators more comfort that they are not too far out there and there is solid and influential support amongst thought leaders in the research community for this approach.

Then when some blogger says otherwise, or some columnist with a desire to smash small companies and create angst for the sake of building his personal reputation, they can be considered as not really being all that important. It might momentarily influence the stock market, or increase some shorting, but not the scientific community or regulators.