NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

It’s absolutely NOT bizarre why they waited. 1) a key policy is still not final, and was not then (ECA); and 2) yes, the FDA approved silently, and they may have been directed that way but the FDA likes to talk out of both sides of its mouth… they will confirm that silence means approval through some low level nobody who will likely also tell you you can’t rely on anything he says.

So then you change it and then, when they get it, they have the right to pretend they never approved anything or said anything (because they do not do so as a matter of fact, and policy, as they do not at the beginning also for the first SAP, but shorts pretend this is different) about the SAP, and given Adam Fuerstein and crew, and those who use his columns to wreak havoc legally, I can imagine they were advised that since updating is on them, there were risks updating before final confirmation of actual marketing approval on the basis of the actually approval updated SAP because of the backwards way the FDA runs it’s regulatory approval process . The disconnect between the FDA approving the SAP but not themselves then confirming it with the database approval, as is done in Europe, is intentionally ambiguous and likely puts them in a risky situation if the FDA doubles back at the end of the day. I won’t explain more but I would guess that a good lawyer would advice them that there was real jeopardy if the FDA is fickle, which we all know they do sometimes. The risk might seem low, but is always a risk.

The FDA wants to be responsible for nothing financial, and will always take full advantage and opportunity to do whatever they claim they think is necessary for drug safety and public safety (ignoring their mess with opioids and other mistakes they have made that they never admit). They may at times seem to fall short of that, but that is their face saving tactic and it is very political, but that is the reality due to the LAW and interpretations of courts that for policy reasons, give the FDA that incredible discretion to be that two faced.

It sucks to be a tiny drug company and let’s face it, a complex trial like this, involving cell therapies that the FDA has been institutionally very hard on for years, was not typically what the FDA had in mind. The FDA deals with such trials consistently ultimately in my opinion, but on a very careful case-by-case basis. I believe NWBO is very carefully lining everything up, without putting the company at risk with debt, like Dendreon did. The FDA is also reforming because of things like the 21st Century Cures Act but still it is happening very slowly and even then because the organization is very, very conservative and wants to reserve all power to itself.

So yes, I can see why they delayed and why it was in fact immaterial though placing blame on the company for 5/10 that it had to do with this, when it absolutely had nothing to do with this, suits some people’s spun narrative that you can’t trust management and they are incompetent. That’s a false narrative.