Replies to post #418390 on NorthWest Biotherapeutics Inc (NWBO)

[kfa670]

That's funny :)



Still screams incompetence to me though

[biosectinvestor]

I doubt that. They likely knew it would take some time. But the issues for this trial are not purely scientific. They relate to regulatory matters, screwed up by regulators who did not understand the ins and outs of immunotherapies or cell therapies when this trial started and they created unnecessary barriers that today would be be better managed for other trials. New procedures are in fact being written and guidelines to address the very issues that caused regulators to screw this up.

No regulator will ever say “yes, regulators screwed this up”. No company will likely ever say it or not certainly before the end of the process.

The reality is, in my opinion, everyone knows this should be approved, even the critics, but getting it across the finish line has always been the challenge. Even the most vehement critics basically were saying that for years also before they realized it might actually succeed, then they started yelling “fraud” as the best way to stop it or undermine credibility.

The reality is that clinical trials are a fusion of science, laws, procedures and regulatory policies. I won’t go into more detail here, but that is the reality. Making pronouncements of clinical “results” by definition, is part of a regulatory process, multiple regulatory processes in fact, and they involve that fusion of different areas of social validation.

Anyway, everything is almost in place for the regulators to be able to address what is obvious, in a manner that makes sense. But it’s not all final. And regardless of what way they chose to proceed with, whether presentation at a conference or publication, in my opinion, they can announce nothing until a certain clarity is achieved that is still pending because of regulatory caution broadly on certain reforms that will figure highly in the ultimate validation of the results here.

None of that would have been sped by a full time CRO or by which form of presentation of results they chose, in my opinion. I think the regulatory effort should be done soon. And I could be wrong on that as to what, when and how. It is all just my opinion and people should do their own diligence.